G Model BONSOI-4150; No. of Pages 4
ARTICLE IN PRESS Joint Bone Spine xxx (2015) xxx–xxx
Available online at
ScienceDirect www.sciencedirect.com
Original article
Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot open-label uncontrolled trial conducted outside the operating theatre夽 Bertrand Lecoq a,∗,1 , Nathalie Hanouz b , Rémy Morello c , Pierre-Yves Jean-Jacques a , Jean-Jacques Dutheil c , Christophe Hulet b , Christian Marcelli a a
Department of Rheumatology, Caen University Hospital, avenue de la Côte de Nacre, BP 95182, 14033 Caen cedex 9, France Department of Orthopaedics, Caen University Hospital, avenue de la Côte de Nacre, BP 95182, 14033 Caen cedex 9, France c Department of Biostatistics, Caen University Hospital, avenue de la Côte de Nacre, BP 95182, 14033 Caen cedex 9, France b
a r t i c l e
i n f o
Article history: Accepted 29 January 2015 Available online xxx Keywords: Carpal tunnel Sonography Ultrasound Surgery Surgical release
a b s t r a c t Objective: To confirm the feasibility of ultrasound-assisted surgical release of carpal tunnel syndrome in the interventional radiology room. Materials and methods: Study involving 39 patients suffering from carpal tunnel syndrome confirmed by electromyogram and unresponsive to medical treatment. The patients were recruited via orthopedic surgery and rheumatology consultations and were operated on in the interventional radiology room under local anesthesia. A single approach was used, at the wrist flexion crease. Patients were monitored over a 90-day period. This is a descriptive open-label uncontrolled study. Results: Fifteen men and 24 women, aged between 21 and 86 years, were included, 23 of whom were in work. The mean surgical procedure time was of 19.0 ± 4.6 minutes; the mean room occupancy time was of 38.0 ± 8.1 minutes and the mean volume of local anesthetic used was of 14.7 ± 2.3 cc. The score for pain, formication and discomfort experienced in the hand was significantly reduced by day 15 (49.1 ± 21.1 vs. 23.5 ± 19.5; P < 0.001). Eight patients continued to present with paresthesia on day15 and only 3 by day 30. Four patients had returned to work by day 15, 10 patients considered that they could have resumed work within an average of 9.9 ± 4.9 days after the procedure. Twenty-five patients estimated that they could resume their daily activities within a mean period of 7 ± 3.9 days. No postoperative complications related to the procedure were observed. Conclusion: According to the results of this study, ultrasound-assisted surgical release of carpal tunnel syndrome performed outside the operating theatre seems to be effective and well-tolerated. © 2015 Société franc¸aise de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.
In the United States, carpal tunnel syndrome (CTS) affects 1% of the general population and 5% of the active population [1]. Carpal tunnel surgery is the most frequent of hand and wrist surgical procedures in the USA, with more than 500,000 surgical procedures per year [2]. The direct costs induced by this disease in the US are of 1 billion dollars per year [1]. CTS is responsible for a significant loss of working days (National Center for Health
夽 This study was promoted by the Caen University Hospital, Caen, France. ∗ Corresponding author. Tel.: +33 2 31 06 47 55; fax: +33 2 31 06 49 63. E-mail address: [email protected] (B. Lecoq). 1 The corresponding author certifies that all authors approved the entirety of the submitted material and contributed actively to the study.
Statistics). According to the Bureau of Labor and Statistics and the National Institute for Occupational Safety and Health-NIOSH, CTS affects 8 million Americans and in half of these cases, the CTS is linked to professional activity. Twenty-five percent of persons working on computer keyboards suffer from CTS. Only 23% of patients operated for CTS are able to resume their previous work. Carpal tunnel syndrome is a disease caused by compression of the median nerve. The most frequently observed symptom is a sensation of formication (or acroparesthesia) in the first 3 to 4 fingers, generally when sleeping or waking up. Other symptoms, such as numbness of the fingers or clumsiness, may also be reported. When a surgical indication is established, two surgical approaches are currently available to treat carpal tunnel syndrome:
http://dx.doi.org/10.1016/j.jbspin.2015.01.024 1297-319X/© 2015 Société franc¸aise de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.
Please cite this article in press as: Lecoq B, et al. Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot openlabel uncontrolled trial conducted outside the operating theatre. Joint Bone Spine (2015), http://dx.doi.org/10.1016/j.jbspin.2015.01.024
G Model BONSOI-4150; No. of Pages 4 2
ARTICLE IN PRESS B. Lecoq et al. / Joint Bone Spine xxx (2015) xxx–xxx
the mini-open or open technique and the endoscopic technique. Both of these procedures, performed on an outpatient basis, share a common goal: flexor retinaculum section. The two techniques differ in the direction of retinaculum section. Mini-open surgery consists in performing a two to three-centimeter incision in the heel of the hand (this technique involves a partially “blind” section of the retinaculum up to 6–8 cm depending on the surgeon), followed by the section of all structures superficial to the carpal tunnel (cellulo-adipose tissue). The initial sections of the flexor retinaculum under endoscopic control were reported in 1990. The two most frequently used techniques are single-portal techniques using Agee instruments [3] and two-portal techniques derived from the Chow technique [4]. Both of these techniques are performed in the operating theatre, under neuroleptanalgesia and local or locoregional anesthesia. The singleportal endoscopic technique requires the use of sophisticated and expensive equipment. It involves making a one to two-centimeter skin incision transversal to the proximal palmar crease of the wrist in order to insert relatively voluminous equipment. Two-portal techniques involve a five-millimeter proximal incision in the proximal palmar crease of the wrist, along with a second incision at the intersection of the axis of the third commissure with a horizontal line passing through the base of the thumb. An endoscope connected to a video control system is inserted through one of the portals, while the cutting equipment is inserted through the opposite incision. Over the past years, the size of the incisions required for mini-open surgery has decreased significantly: it is currently of circa 1 to 2 cm. For endoscopy, distal and proximal incisions of approximately 1 cm are made. Whatever the technique used, carpal tunnel surgery complications are mainly nervous, vascular or tendinous, infections, transient neurological disturbances disappearing within 6 months, or bone complications (algodystrophy). Several recent publications have highlighted more rapid recovery when the incision is small and when the procedures are performed under endoscopic control [5–7]. The purpose of developing a new technique is to reduce the side effects associated with surgery (infection, algodystrophy, scar tissue formation), to limit the prescription of work stoppages (currently 3 to 6 weeks for a surgical procedure) and to reduce induced costs. Carpal tunnel ultrasound has been used for many years, particularly for diagnostic and etiological purposes [8,9]. Recently, a study of the surgical release of carpal tunnel syndrome under ultrasound control was published [10]. In this study, the authors showed that the surgical release of CTS under ultrasound control gives equally satisfactory results as the mini-open technique and generates fewer postoperative complications. This technique also accelerates recovery and resumption of activity. The study involved thirty-five carpal tunnels compared in a non-random fashion to thirty-nine carpal tunnels release by the mini-open technique. A recent study on 104 cadavers has demonstrated that when the technique is performed under ultrasound control, the portal is reduced and retinaculum section rendered more secure [11]. The approach in that study was at the wrist flexion crease rather than distal to the carpal tunnel in the palm of the hand as described by Nakamichi et al. [10]. The authors then conducted an open study in the operating theatre on 25 patients [11]. The carpal tunnel syndrome disappeared for all patients. No side effects were reported during the 3-month patient follow-up. Most patients were able to resume their professional activity rapidly, sometimes in just a few days. Therefore, the purpose of this study was to confirm the feasibility of ultrasound-assisted surgical release of carpal tunnel syndrome (CTS) in the interventional radiology room.
1. Methods 1.1. Patients Patients were enrolled from by non-operator physicians from rheumatology and orthopedic surgery consultations. A clinical assessment was performed by the rheumatologist. An EMG was performed as a pre-therapy assessment. The ultrasound was performed by the ultrasound specialist investigator-operator rheumatologist. After the procedure, follow-up visits were organized at 15 days (D15), 1 month (D30) and 3 months (D90) with the non-operator rheumatologist or orthopedic surgeon, with evaluation of efficacy and of iatrogenicity if any. Additional visits were scheduled if required, depending on tolerance. This is a descriptive uncontrolled study (open-label, a single arm). 1.2. Surgical procedure Patients were managed by the radiology department in the interventional radiology room. They were placed on an interventional radiology table fitted with an arm and forearm rest. The ultrasound instrument was placed at a distance from the table with the monitor facing the operator (ESAOTE Technos Mpx, 13 MHz). An assistant (nurse) was present in the room, in addition to the operator. The operator was either an orthopedic surgeon, specialist of the hand-surgery and trained in the ultrasound, or an interventional rheumatologist. The patient was not perfused. We used a standard ultrasound instrument with 13 MHz probe. The operator had sterile gloves, surgical gown, surgical hoods and sterile gloves (Fig. 1). Before placing the sterile drapes, the various ultrasound parameters (depth, focal length, gain, etc.) were adjusted, and the limits of the carpal tunnel marked (Fig. 2),
Fig. 1. Patient and equipment installation in the interventional radiology room.
Fig. 2. Location of the median nerve (1) and flexor retinaculum (2) at the exit of the carpal tunnel, facing the hamatum hamulus (3).
Please cite this article in press as: Lecoq B, et al. Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot openlabel uncontrolled trial conducted outside the operating theatre. Joint Bone Spine (2015), http://dx.doi.org/10.1016/j.jbspin.2015.01.024
G Model BONSOI-4150; No. of Pages 4
ARTICLE IN PRESS B. Lecoq et al. / Joint Bone Spine xxx (2015) xxx–xxx
3
Fig. 5. Cut transverse to the carpal tunnel, showing the blade in horizontal noncutting position (1) with its shadow cone (3) and the median nerve (2). On the right side, the blade which we used.
Fig. 3. Location of the median nerve (1) and its relationship to the ulnar nerve and vascular bundle (2).
ultrasound monitoring and scalpel manipulation to be synchronized. Once the first passage is complete, the scalpel is removed and the ligament section is checked by re-inserting the trocar with its mandril. The retinaculum is cut along its entire length, from the distal insertion facing the hamatum hamulus to the scaphoid tubercle. The operator ensured that the ligament had been completely cut by looking with the ultrasound. In the event of incomplete section, the operation was repeated. The procedure ended with a single subcutaneous stitch using absorbable thread. 1.3. Outcome measures
Fig. 4. A single operator performs the procedure, trocar in the right hand and ultrasound probe in the left hand (1: median nerve, 2: blade, 3: retinaculum flexor ligament).
along with its relationship to the ulnar nerve and vascular bundle (Fig. 3). We used the color Doppler (80% of gain) to visualise ulnar vessels and to search a median persistant artery. The procedure started with local anesthesia using lidocaine. Ten to 20 cc of lidocaine were injected into the subcutaneous space from the trocar puncture point in the wrist flexion crease to the surface of the flexor retinaculum. Next, a 5 mm transverse incision was made along the axis of the 4th radius, 1 cm up from the wrist proximal flexion crease and avoiding the superficial venous plexus. The portal was then delicately initiated using dissecting scissors. An arthroscopy trocar (5 mm of diameter), mandril in place, was then guided into the carpal tunnel (Fig. 4). Insertion into the carpal tunnel was ascertained by palpation. Ultrasound was used to ensure that the trocar was in the correct position: at mid-distance between the median nerve outside and the ulnar nerve and vascular package inside. The ligament was tensed by bottom to top movements made with the trocar, ensuring that it was positioned at the inner surface of the flexor retinaculum. Once the trocar was in place, the mandril was removed and replaced by a retrograde scalpel. The scalpel was first placed in the horizontal position, cutting plane looking towards the hypothenar compartment. The horizontal placement creates a larger shadow cone, thus facilitating its location (Fig. 5). The distal limit of the section is located by the hamatum hamulus. This bone eminence is important, it allows easy location of the distal end of the carpal tunnel and hence the distal insertion of the flexor retinaculum. If the retinaculum cannot be viewed correctly, this provides a reliable location for the section area. The trocar was then removed and the scalpel placed in vertical cutting position. Finally, the retinaculum was cut in a retrograde fashion along its whole length and under strict ultrasound control. Throughout the procedure, the scalpel blade, retinaculum, ulnar vessels, inner and subcutaneous planes and the median nerve, along with any branches and divisions are viewed simultaneously. There is only one operator, thus enabling
The primary aim of this study was to confirm the feasibility of ultrasound-assisted surgical release of carpal tunnel syndrome in the interventional radiology room. The outcome measures used were procedure tolerance, the lack of postoperative complications and good tolerance of the local anesthetic and the absence of infectious complications. The secondary aims were to demonstrate, after ultrasoundassisted surgical release, a disappearance of carpal tunnel syndrome and to assess the time to resumption of professional and daily life activities. The following evaluation methods were used: • a “pain, paresthesia, discomfort” score was used to quantify the initial ailment and the response to treatment. The patients were asked to answer the following question: “Over the past 48 hours, how would you describe the overall pain, formication and discomfort experienced in your hand?” A visual analogue scale was used; • the ability to resume work, where applicable, was evaluated by means of a targeted question. Patients with a professional activity were asked to answer the following question: “Concerning your ability to return to work: how many days after the procedure would you have been able to resume your professional activity?” The ability to resume the activities of daily life was evaluated for all patients. The following question was asked: “Concerning your ability to resume your normal life: how many days after the procedure would you have been able to resume your daily activities?” 1.4. Statistical analysis Quantitative variables were described using means and standard deviations (SD). Qualitative variables were described using frequencies and percentages. The ANOVA for repeated measures was used to compare the means of quantitative at different times. All pairwise comparisons were performed by a Bonferroni test. All the tests were two-tailed and their level of significance (P) was defined as P < 0.05. IBM® -SPSS® 20.0 for Windows® was the statistical software used.
Please cite this article in press as: Lecoq B, et al. Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot openlabel uncontrolled trial conducted outside the operating theatre. Joint Bone Spine (2015), http://dx.doi.org/10.1016/j.jbspin.2015.01.024
G Model
ARTICLE IN PRESS
BONSOI-4150; No. of Pages 4
B. Lecoq et al. / Joint Bone Spine xxx (2015) xxx–xxx
4 Table 1 Activity of the group of patients. Type of activity (valid)
Population
Percent valid
In work On sick leave On disability leave Unemployed (Early) retirement No data known Total
23 3 2 1 9 1 39
58.9 7.6 5.1 2.5 23.0 2.5 100.0
The institutional review board of our institution approved this analysis and informed consent was obtained from every patients. 2. Results Fifteen men and 24 women, aged between 21 and 86 years, were included, 23 of whom were in work (Table 1). The mean surgical procedure time was of 19.0 ± 4.6 minutes; the mean room occupancy time was of 38.0 ± 8.1 minutes and the mean volume of lidocaine injected was of 14.7 ± 2.3 cc. The score for pain, formication and discomfort experienced in the hand was significantly reduced by D15 (49.1 ± 21.1 vs. 23.5 ± 19.5; P < 0.001). Eight patients continued to present with paraesthesia on D15 and only 3 by D30. Patients with a professional activity were systematically placed on leave for 4 weeks, as is standard for the management of carpal tunnel syndrome. Four of these patients, however, resumed their work at D15. Ten of the 23 patients with a professional activity estimated that they could have returned to work within a mean period of 9.9 ± 4.9 days after the procedure. Twenty-five patients estimated that they could resume their daily activities within a mean period of 7.0 ± 3.9 days. No per- or postoperative complications related to the procedure were observed. Only 2 patients experienced a fainting sensation during the procedure, though without loss of consciousness. In both cases, the procedure was completed and no particular additional care was required; the heat in the non-air conditioned room was the trigger for both of these patients. No septic complications associated with the procedure performed outside the operating theatre were observed in any patient. 3. Discussion The results of our study confirm the benefit of using ultrasound in the surgical release of CTS. The good outcome after treatment for most patients, along with the lack of iatrogenic complications associated with the non-operating theatre procedure, are major elements driving us to consider a prospective study comparing this procedure to the mini-open surgical procedure, which is the reference surgical technique. It would be interesting, during this study, to conduct a medico-economic analysis. In the past, other endoscopy-related studies had demonstrated that reducing skin opening gave better results [3,12]. The use of ultrasound further limits the skin opening, thus reducing complications [6]. Currently, the enthusiasm shown for the development of this ultrasound surgical technique is growing: several teams are working on the carpal tunnel [10,11,13]. The retinaculum section and approach techniques vary between teams [10,11,13]. Like Lecoq et al. [11] and Rojo et al. [13], we preferred a retrograde section and a wrist approach, whereas Nakamichi et al. [11] used a palm of the hand approach, in front of the palmar arch. We considered that it would be much easier to locate the distal end of
the carpal tunnel from a proximal approach, using the arthroscopy cannula as a probe. Moreover, the proximal approach is a relatively easy approach, far from those vascular and nervous structures that tend to cause complications in the event of poor section. Scars at the flexion crease are probably better tolerated, less fibrous and less exposed to pressure than scars on the heel of the hand. There does not seem to be any difference according to the approach chosen in terms of operating difficulties; the aim is not currently to compare these ultrasound-assisted surgical techniques, but rather to continue the studies initiated to demonstrate the superiority of the ultrasound-assisted surgical approach to the carpal tunnel over the conventional surgical approach, whether arthroscopic or open. Our study shows the harmlessness of ultrasound-assisted surgery of the carpal tunnel outside of the operating theatre. It opens interesting prospects concerning the “lightening” of this procedure, along with the potential savings, in addition to the direct benefit for the patient. According to the results of this study, ultrasound-assisted surgical release of CTS performed outside the operating theatre seems to be effective and well-tolerated. In order to confirm the clinical and economic advantages of our technique, we aim at conducting a prospective multi-centre study to compare it to the mini-open and endoscopic surgical techniques. Disclosure of interest The authors declare that they have no conflicts of interest concerning this article. Acknowledgments We would like to thank the rheumatology, radiology and orthopaedics departments, along with the Caen University anatomy laboratory. References [1] Concannon MJ, Brownfield ML, Puckett CL. The incidence of recurrence after endoscopic carpal tunnel release. Plast Reconstr Surg 2000;105:1662–5. [2] Jain NB, Higgins LD, Losina E, et al. Epidemiology of musculoskeletal upper extremity ambulatory surgery in the United States. BMC Musculoskelet Disord 2014;15:4. [3] Agee JM, McCarroll Jr HR, Tortosa RD, et al. Endoscopic release of the carpal tunnel: a randomized prospective multicenter study. J Hand Surg Am 1992;17:987–95. [4] Chow JC. Endoscopic release of the carpal ligament: a new technique for carpal tunnel syndrome. Arthroscopy 1989;5:19–24. [5] Chen L, Duan X, Huang X, et al. Effectiveness and safety of endoscopic versus open carpal tunnel decompression. Arch Orthop Trauma Surg 2014;134:585–93. [6] Thoma A, Veltri K, Haines T, et al. A systematic review of reviews comparing the effectiveness of endoscopic and open carpal tunnel decompression. Plast Reconstr Surg 2004;113:1184–91. [7] Okamura A, Meirelles LM, Fernandes CH, et al. Evaluation of patients with carpal tunnel syndrome treated by endoscopic technique. Acta Orthop Bras 2014;22:29–33. [8] Sernik RA, Abicalaf CA, Pimentel BF, et al. Ultrasound features of carpal tunnel syndrome: a prospective case control study. Skeletal Radiol 2008;37:49–53. [9] Mallouhi A, Pülzl P, Trieb T, et al. Predictors of carpal tunnel syndrome: accuracy of gray-scale and color Doppler sonography. AJR Am J Roentgenol 2006;186:1240–5. [10] Nakamichi K, Tachibana S, Yamamoto S, et al. Percutaneous carpal tunnel release compared with mini-open release using ultrasonographic guidance for both techniques. J Hand Surg Am 2010;35:437–45. [11] Lecoq B, Hanouz N, Vielpeau C, et al. Ultrasound-guided percutaneous surgery for carpal tunnel syndrome: a cadaver study. Joint Bone Spine 2011;78:516–8. [12] Keith MW, Masear V, Amadio PC, et al. Treatment of carpal tunnel syndrome. J Am Acad Orthop Surg 2009;17:397–405. [13] Rojo-Manaute JM, Capa-Grasa A, Rodríguez-Maruri GE, et al. Ultra-minimally invasive sonographically guided carpal tunnel release: anatomic study of a new technique. J Ultrasound Med 2013;32:131–42.
Please cite this article in press as: Lecoq B, et al. Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot openlabel uncontrolled trial conducted outside the operating theatre. Joint Bone Spine (2015), http://dx.doi.org/10.1016/j.jbspin.2015.01.024
ARTICLE IN PRESS Joint Bone Spine xxx (2015) xxx–xxx
Available online at
ScienceDirect www.sciencedirect.com
Original article
Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot open-label uncontrolled trial conducted outside the operating theatre夽 Bertrand Lecoq a,∗,1 , Nathalie Hanouz b , Rémy Morello c , Pierre-Yves Jean-Jacques a , Jean-Jacques Dutheil c , Christophe Hulet b , Christian Marcelli a a
Department of Rheumatology, Caen University Hospital, avenue de la Côte de Nacre, BP 95182, 14033 Caen cedex 9, France Department of Orthopaedics, Caen University Hospital, avenue de la Côte de Nacre, BP 95182, 14033 Caen cedex 9, France c Department of Biostatistics, Caen University Hospital, avenue de la Côte de Nacre, BP 95182, 14033 Caen cedex 9, France b
a r t i c l e
i n f o
Article history: Accepted 29 January 2015 Available online xxx Keywords: Carpal tunnel Sonography Ultrasound Surgery Surgical release
a b s t r a c t Objective: To confirm the feasibility of ultrasound-assisted surgical release of carpal tunnel syndrome in the interventional radiology room. Materials and methods: Study involving 39 patients suffering from carpal tunnel syndrome confirmed by electromyogram and unresponsive to medical treatment. The patients were recruited via orthopedic surgery and rheumatology consultations and were operated on in the interventional radiology room under local anesthesia. A single approach was used, at the wrist flexion crease. Patients were monitored over a 90-day period. This is a descriptive open-label uncontrolled study. Results: Fifteen men and 24 women, aged between 21 and 86 years, were included, 23 of whom were in work. The mean surgical procedure time was of 19.0 ± 4.6 minutes; the mean room occupancy time was of 38.0 ± 8.1 minutes and the mean volume of local anesthetic used was of 14.7 ± 2.3 cc. The score for pain, formication and discomfort experienced in the hand was significantly reduced by day 15 (49.1 ± 21.1 vs. 23.5 ± 19.5; P < 0.001). Eight patients continued to present with paresthesia on day15 and only 3 by day 30. Four patients had returned to work by day 15, 10 patients considered that they could have resumed work within an average of 9.9 ± 4.9 days after the procedure. Twenty-five patients estimated that they could resume their daily activities within a mean period of 7 ± 3.9 days. No postoperative complications related to the procedure were observed. Conclusion: According to the results of this study, ultrasound-assisted surgical release of carpal tunnel syndrome performed outside the operating theatre seems to be effective and well-tolerated. © 2015 Société franc¸aise de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.
In the United States, carpal tunnel syndrome (CTS) affects 1% of the general population and 5% of the active population [1]. Carpal tunnel surgery is the most frequent of hand and wrist surgical procedures in the USA, with more than 500,000 surgical procedures per year [2]. The direct costs induced by this disease in the US are of 1 billion dollars per year [1]. CTS is responsible for a significant loss of working days (National Center for Health
夽 This study was promoted by the Caen University Hospital, Caen, France. ∗ Corresponding author. Tel.: +33 2 31 06 47 55; fax: +33 2 31 06 49 63. E-mail address: [email protected] (B. Lecoq). 1 The corresponding author certifies that all authors approved the entirety of the submitted material and contributed actively to the study.
Statistics). According to the Bureau of Labor and Statistics and the National Institute for Occupational Safety and Health-NIOSH, CTS affects 8 million Americans and in half of these cases, the CTS is linked to professional activity. Twenty-five percent of persons working on computer keyboards suffer from CTS. Only 23% of patients operated for CTS are able to resume their previous work. Carpal tunnel syndrome is a disease caused by compression of the median nerve. The most frequently observed symptom is a sensation of formication (or acroparesthesia) in the first 3 to 4 fingers, generally when sleeping or waking up. Other symptoms, such as numbness of the fingers or clumsiness, may also be reported. When a surgical indication is established, two surgical approaches are currently available to treat carpal tunnel syndrome:
http://dx.doi.org/10.1016/j.jbspin.2015.01.024 1297-319X/© 2015 Société franc¸aise de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.
Please cite this article in press as: Lecoq B, et al. Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot openlabel uncontrolled trial conducted outside the operating theatre. Joint Bone Spine (2015), http://dx.doi.org/10.1016/j.jbspin.2015.01.024
G Model BONSOI-4150; No. of Pages 4 2
ARTICLE IN PRESS B. Lecoq et al. / Joint Bone Spine xxx (2015) xxx–xxx
the mini-open or open technique and the endoscopic technique. Both of these procedures, performed on an outpatient basis, share a common goal: flexor retinaculum section. The two techniques differ in the direction of retinaculum section. Mini-open surgery consists in performing a two to three-centimeter incision in the heel of the hand (this technique involves a partially “blind” section of the retinaculum up to 6–8 cm depending on the surgeon), followed by the section of all structures superficial to the carpal tunnel (cellulo-adipose tissue). The initial sections of the flexor retinaculum under endoscopic control were reported in 1990. The two most frequently used techniques are single-portal techniques using Agee instruments [3] and two-portal techniques derived from the Chow technique [4]. Both of these techniques are performed in the operating theatre, under neuroleptanalgesia and local or locoregional anesthesia. The singleportal endoscopic technique requires the use of sophisticated and expensive equipment. It involves making a one to two-centimeter skin incision transversal to the proximal palmar crease of the wrist in order to insert relatively voluminous equipment. Two-portal techniques involve a five-millimeter proximal incision in the proximal palmar crease of the wrist, along with a second incision at the intersection of the axis of the third commissure with a horizontal line passing through the base of the thumb. An endoscope connected to a video control system is inserted through one of the portals, while the cutting equipment is inserted through the opposite incision. Over the past years, the size of the incisions required for mini-open surgery has decreased significantly: it is currently of circa 1 to 2 cm. For endoscopy, distal and proximal incisions of approximately 1 cm are made. Whatever the technique used, carpal tunnel surgery complications are mainly nervous, vascular or tendinous, infections, transient neurological disturbances disappearing within 6 months, or bone complications (algodystrophy). Several recent publications have highlighted more rapid recovery when the incision is small and when the procedures are performed under endoscopic control [5–7]. The purpose of developing a new technique is to reduce the side effects associated with surgery (infection, algodystrophy, scar tissue formation), to limit the prescription of work stoppages (currently 3 to 6 weeks for a surgical procedure) and to reduce induced costs. Carpal tunnel ultrasound has been used for many years, particularly for diagnostic and etiological purposes [8,9]. Recently, a study of the surgical release of carpal tunnel syndrome under ultrasound control was published [10]. In this study, the authors showed that the surgical release of CTS under ultrasound control gives equally satisfactory results as the mini-open technique and generates fewer postoperative complications. This technique also accelerates recovery and resumption of activity. The study involved thirty-five carpal tunnels compared in a non-random fashion to thirty-nine carpal tunnels release by the mini-open technique. A recent study on 104 cadavers has demonstrated that when the technique is performed under ultrasound control, the portal is reduced and retinaculum section rendered more secure [11]. The approach in that study was at the wrist flexion crease rather than distal to the carpal tunnel in the palm of the hand as described by Nakamichi et al. [10]. The authors then conducted an open study in the operating theatre on 25 patients [11]. The carpal tunnel syndrome disappeared for all patients. No side effects were reported during the 3-month patient follow-up. Most patients were able to resume their professional activity rapidly, sometimes in just a few days. Therefore, the purpose of this study was to confirm the feasibility of ultrasound-assisted surgical release of carpal tunnel syndrome (CTS) in the interventional radiology room.
1. Methods 1.1. Patients Patients were enrolled from by non-operator physicians from rheumatology and orthopedic surgery consultations. A clinical assessment was performed by the rheumatologist. An EMG was performed as a pre-therapy assessment. The ultrasound was performed by the ultrasound specialist investigator-operator rheumatologist. After the procedure, follow-up visits were organized at 15 days (D15), 1 month (D30) and 3 months (D90) with the non-operator rheumatologist or orthopedic surgeon, with evaluation of efficacy and of iatrogenicity if any. Additional visits were scheduled if required, depending on tolerance. This is a descriptive uncontrolled study (open-label, a single arm). 1.2. Surgical procedure Patients were managed by the radiology department in the interventional radiology room. They were placed on an interventional radiology table fitted with an arm and forearm rest. The ultrasound instrument was placed at a distance from the table with the monitor facing the operator (ESAOTE Technos Mpx, 13 MHz). An assistant (nurse) was present in the room, in addition to the operator. The operator was either an orthopedic surgeon, specialist of the hand-surgery and trained in the ultrasound, or an interventional rheumatologist. The patient was not perfused. We used a standard ultrasound instrument with 13 MHz probe. The operator had sterile gloves, surgical gown, surgical hoods and sterile gloves (Fig. 1). Before placing the sterile drapes, the various ultrasound parameters (depth, focal length, gain, etc.) were adjusted, and the limits of the carpal tunnel marked (Fig. 2),
Fig. 1. Patient and equipment installation in the interventional radiology room.
Fig. 2. Location of the median nerve (1) and flexor retinaculum (2) at the exit of the carpal tunnel, facing the hamatum hamulus (3).
Please cite this article in press as: Lecoq B, et al. Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot openlabel uncontrolled trial conducted outside the operating theatre. Joint Bone Spine (2015), http://dx.doi.org/10.1016/j.jbspin.2015.01.024
G Model BONSOI-4150; No. of Pages 4
ARTICLE IN PRESS B. Lecoq et al. / Joint Bone Spine xxx (2015) xxx–xxx
3
Fig. 5. Cut transverse to the carpal tunnel, showing the blade in horizontal noncutting position (1) with its shadow cone (3) and the median nerve (2). On the right side, the blade which we used.
Fig. 3. Location of the median nerve (1) and its relationship to the ulnar nerve and vascular bundle (2).
ultrasound monitoring and scalpel manipulation to be synchronized. Once the first passage is complete, the scalpel is removed and the ligament section is checked by re-inserting the trocar with its mandril. The retinaculum is cut along its entire length, from the distal insertion facing the hamatum hamulus to the scaphoid tubercle. The operator ensured that the ligament had been completely cut by looking with the ultrasound. In the event of incomplete section, the operation was repeated. The procedure ended with a single subcutaneous stitch using absorbable thread. 1.3. Outcome measures
Fig. 4. A single operator performs the procedure, trocar in the right hand and ultrasound probe in the left hand (1: median nerve, 2: blade, 3: retinaculum flexor ligament).
along with its relationship to the ulnar nerve and vascular bundle (Fig. 3). We used the color Doppler (80% of gain) to visualise ulnar vessels and to search a median persistant artery. The procedure started with local anesthesia using lidocaine. Ten to 20 cc of lidocaine were injected into the subcutaneous space from the trocar puncture point in the wrist flexion crease to the surface of the flexor retinaculum. Next, a 5 mm transverse incision was made along the axis of the 4th radius, 1 cm up from the wrist proximal flexion crease and avoiding the superficial venous plexus. The portal was then delicately initiated using dissecting scissors. An arthroscopy trocar (5 mm of diameter), mandril in place, was then guided into the carpal tunnel (Fig. 4). Insertion into the carpal tunnel was ascertained by palpation. Ultrasound was used to ensure that the trocar was in the correct position: at mid-distance between the median nerve outside and the ulnar nerve and vascular package inside. The ligament was tensed by bottom to top movements made with the trocar, ensuring that it was positioned at the inner surface of the flexor retinaculum. Once the trocar was in place, the mandril was removed and replaced by a retrograde scalpel. The scalpel was first placed in the horizontal position, cutting plane looking towards the hypothenar compartment. The horizontal placement creates a larger shadow cone, thus facilitating its location (Fig. 5). The distal limit of the section is located by the hamatum hamulus. This bone eminence is important, it allows easy location of the distal end of the carpal tunnel and hence the distal insertion of the flexor retinaculum. If the retinaculum cannot be viewed correctly, this provides a reliable location for the section area. The trocar was then removed and the scalpel placed in vertical cutting position. Finally, the retinaculum was cut in a retrograde fashion along its whole length and under strict ultrasound control. Throughout the procedure, the scalpel blade, retinaculum, ulnar vessels, inner and subcutaneous planes and the median nerve, along with any branches and divisions are viewed simultaneously. There is only one operator, thus enabling
The primary aim of this study was to confirm the feasibility of ultrasound-assisted surgical release of carpal tunnel syndrome in the interventional radiology room. The outcome measures used were procedure tolerance, the lack of postoperative complications and good tolerance of the local anesthetic and the absence of infectious complications. The secondary aims were to demonstrate, after ultrasoundassisted surgical release, a disappearance of carpal tunnel syndrome and to assess the time to resumption of professional and daily life activities. The following evaluation methods were used: • a “pain, paresthesia, discomfort” score was used to quantify the initial ailment and the response to treatment. The patients were asked to answer the following question: “Over the past 48 hours, how would you describe the overall pain, formication and discomfort experienced in your hand?” A visual analogue scale was used; • the ability to resume work, where applicable, was evaluated by means of a targeted question. Patients with a professional activity were asked to answer the following question: “Concerning your ability to return to work: how many days after the procedure would you have been able to resume your professional activity?” The ability to resume the activities of daily life was evaluated for all patients. The following question was asked: “Concerning your ability to resume your normal life: how many days after the procedure would you have been able to resume your daily activities?” 1.4. Statistical analysis Quantitative variables were described using means and standard deviations (SD). Qualitative variables were described using frequencies and percentages. The ANOVA for repeated measures was used to compare the means of quantitative at different times. All pairwise comparisons were performed by a Bonferroni test. All the tests were two-tailed and their level of significance (P) was defined as P < 0.05. IBM® -SPSS® 20.0 for Windows® was the statistical software used.
Please cite this article in press as: Lecoq B, et al. Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot openlabel uncontrolled trial conducted outside the operating theatre. Joint Bone Spine (2015), http://dx.doi.org/10.1016/j.jbspin.2015.01.024
G Model
ARTICLE IN PRESS
BONSOI-4150; No. of Pages 4
B. Lecoq et al. / Joint Bone Spine xxx (2015) xxx–xxx
4 Table 1 Activity of the group of patients. Type of activity (valid)
Population
Percent valid
In work On sick leave On disability leave Unemployed (Early) retirement No data known Total
23 3 2 1 9 1 39
58.9 7.6 5.1 2.5 23.0 2.5 100.0
The institutional review board of our institution approved this analysis and informed consent was obtained from every patients. 2. Results Fifteen men and 24 women, aged between 21 and 86 years, were included, 23 of whom were in work (Table 1). The mean surgical procedure time was of 19.0 ± 4.6 minutes; the mean room occupancy time was of 38.0 ± 8.1 minutes and the mean volume of lidocaine injected was of 14.7 ± 2.3 cc. The score for pain, formication and discomfort experienced in the hand was significantly reduced by D15 (49.1 ± 21.1 vs. 23.5 ± 19.5; P < 0.001). Eight patients continued to present with paraesthesia on D15 and only 3 by D30. Patients with a professional activity were systematically placed on leave for 4 weeks, as is standard for the management of carpal tunnel syndrome. Four of these patients, however, resumed their work at D15. Ten of the 23 patients with a professional activity estimated that they could have returned to work within a mean period of 9.9 ± 4.9 days after the procedure. Twenty-five patients estimated that they could resume their daily activities within a mean period of 7.0 ± 3.9 days. No per- or postoperative complications related to the procedure were observed. Only 2 patients experienced a fainting sensation during the procedure, though without loss of consciousness. In both cases, the procedure was completed and no particular additional care was required; the heat in the non-air conditioned room was the trigger for both of these patients. No septic complications associated with the procedure performed outside the operating theatre were observed in any patient. 3. Discussion The results of our study confirm the benefit of using ultrasound in the surgical release of CTS. The good outcome after treatment for most patients, along with the lack of iatrogenic complications associated with the non-operating theatre procedure, are major elements driving us to consider a prospective study comparing this procedure to the mini-open surgical procedure, which is the reference surgical technique. It would be interesting, during this study, to conduct a medico-economic analysis. In the past, other endoscopy-related studies had demonstrated that reducing skin opening gave better results [3,12]. The use of ultrasound further limits the skin opening, thus reducing complications [6]. Currently, the enthusiasm shown for the development of this ultrasound surgical technique is growing: several teams are working on the carpal tunnel [10,11,13]. The retinaculum section and approach techniques vary between teams [10,11,13]. Like Lecoq et al. [11] and Rojo et al. [13], we preferred a retrograde section and a wrist approach, whereas Nakamichi et al. [11] used a palm of the hand approach, in front of the palmar arch. We considered that it would be much easier to locate the distal end of
the carpal tunnel from a proximal approach, using the arthroscopy cannula as a probe. Moreover, the proximal approach is a relatively easy approach, far from those vascular and nervous structures that tend to cause complications in the event of poor section. Scars at the flexion crease are probably better tolerated, less fibrous and less exposed to pressure than scars on the heel of the hand. There does not seem to be any difference according to the approach chosen in terms of operating difficulties; the aim is not currently to compare these ultrasound-assisted surgical techniques, but rather to continue the studies initiated to demonstrate the superiority of the ultrasound-assisted surgical approach to the carpal tunnel over the conventional surgical approach, whether arthroscopic or open. Our study shows the harmlessness of ultrasound-assisted surgery of the carpal tunnel outside of the operating theatre. It opens interesting prospects concerning the “lightening” of this procedure, along with the potential savings, in addition to the direct benefit for the patient. According to the results of this study, ultrasound-assisted surgical release of CTS performed outside the operating theatre seems to be effective and well-tolerated. In order to confirm the clinical and economic advantages of our technique, we aim at conducting a prospective multi-centre study to compare it to the mini-open and endoscopic surgical techniques. Disclosure of interest The authors declare that they have no conflicts of interest concerning this article. Acknowledgments We would like to thank the rheumatology, radiology and orthopaedics departments, along with the Caen University anatomy laboratory. References [1] Concannon MJ, Brownfield ML, Puckett CL. The incidence of recurrence after endoscopic carpal tunnel release. Plast Reconstr Surg 2000;105:1662–5. [2] Jain NB, Higgins LD, Losina E, et al. Epidemiology of musculoskeletal upper extremity ambulatory surgery in the United States. BMC Musculoskelet Disord 2014;15:4. [3] Agee JM, McCarroll Jr HR, Tortosa RD, et al. Endoscopic release of the carpal tunnel: a randomized prospective multicenter study. J Hand Surg Am 1992;17:987–95. [4] Chow JC. Endoscopic release of the carpal ligament: a new technique for carpal tunnel syndrome. Arthroscopy 1989;5:19–24. [5] Chen L, Duan X, Huang X, et al. Effectiveness and safety of endoscopic versus open carpal tunnel decompression. Arch Orthop Trauma Surg 2014;134:585–93. [6] Thoma A, Veltri K, Haines T, et al. A systematic review of reviews comparing the effectiveness of endoscopic and open carpal tunnel decompression. Plast Reconstr Surg 2004;113:1184–91. [7] Okamura A, Meirelles LM, Fernandes CH, et al. Evaluation of patients with carpal tunnel syndrome treated by endoscopic technique. Acta Orthop Bras 2014;22:29–33. [8] Sernik RA, Abicalaf CA, Pimentel BF, et al. Ultrasound features of carpal tunnel syndrome: a prospective case control study. Skeletal Radiol 2008;37:49–53. [9] Mallouhi A, Pülzl P, Trieb T, et al. Predictors of carpal tunnel syndrome: accuracy of gray-scale and color Doppler sonography. AJR Am J Roentgenol 2006;186:1240–5. [10] Nakamichi K, Tachibana S, Yamamoto S, et al. Percutaneous carpal tunnel release compared with mini-open release using ultrasonographic guidance for both techniques. J Hand Surg Am 2010;35:437–45. [11] Lecoq B, Hanouz N, Vielpeau C, et al. Ultrasound-guided percutaneous surgery for carpal tunnel syndrome: a cadaver study. Joint Bone Spine 2011;78:516–8. [12] Keith MW, Masear V, Amadio PC, et al. Treatment of carpal tunnel syndrome. J Am Acad Orthop Surg 2009;17:397–405. [13] Rojo-Manaute JM, Capa-Grasa A, Rodríguez-Maruri GE, et al. Ultra-minimally invasive sonographically guided carpal tunnel release: anatomic study of a new technique. J Ultrasound Med 2013;32:131–42.
Please cite this article in press as: Lecoq B, et al. Ultrasound-assisted surgical release of carpal tunnel syndrome: Results of a pilot openlabel uncontrolled trial conducted outside the operating theatre. Joint Bone Spine (2015), http://dx.doi.org/10.1016/j.jbspin.2015.01.024
![[Socio professional impact of surgical release of carpal tunnel syndrome].](/assets/img/hold.png)
