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Technology and Health Care 00 (2014) 1–7 DOI 10.3233/THC-140930 IOS Press
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Clinical application for individual placement of intramedullary nail guided by digital technique in tibial fractures Lin Liua,1 , Xian Xua,1 , Xu Lia , Wei Wua , Junfeng Caib and Qingyou Lua,∗ a Department
b Department
of Trauma Surgery, East Hospital Affiliated to Tongji University, Shanghai, China of Joint Surgery, East Hospital Affiliated to Tongji University, Shanghai, China
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Received 28 February 2014 Accepted 22 May 2014
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Keywords: Digital, tibial fractures, intramedullary nail, individual
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1. Introduction
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Tibial fractures are the most common and serious long bone fractures, due to their potential for malunion, nonunion, long-term dysfunction and open injury [1,2]. Intramedullary nailing has become the standard treatment method for closed and most of the open fractures of the long-bone diaphysis (such as displaced/unstable tibial shaft fractures), because it provides a high mechanical stability and can be performed in a minimally invasive manner [3–7].
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Abstract. BACKGROUND: To evaluate the clinical effects of individual placement of intramedullary nail guided by digital technique in the treatment of tibial fractures. METHODS: Thirty-two cases of unilateral tibial fractures treated with individual placement of intramedullary nail guided by digital technique or conventional surgery were collected from October 2010 to October 2012. In the experimental group, the size of intramedullary nail, as well as the distance between the insertion point of tibial intramedullary nail and the line perpendicular to the tibial plateau of the tibial tubercle were measured by digital technology preoperatively to select suitable intramedullary nail and appropriate insertion point. RESULTS: The operative time and bone healing time of the experimental group didn’t change significantly (P > 0.05). There were statistically significant differences in the number of X-ray examinations and the distance between actual and planned nail placement point between experimental group and control group. The excellent and good rate of functional recovery for the experimental and the control group was 100% and 87.50%, respectively. CONCLUSION: Compared with the conventional surgery, individual placement of intramedullary nail guided by digital technique in tibial fractures might have superior outcomes.
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Lin Liu and Xian Xu should be regarded as co-first authors. Corresponding author: Qingyou Lu, Department of Trauma Surgery, East Hospital Affiliated to Tongji University, Shanghai 200120, China. Tel.: +86 13816521820; E-mail: [email protected]. ∗
c 2014 – IOS Press and the authors. All rights reserved 0928-7329/14/$27.50
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2. Materials and methods
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2.1. Study population
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From October 2010 to October 2012, patients were collected according to the following criteria: with unilateral tibial fractures; treated with individual placement of intramedullary nail guided by digital technique (experimental group) or conventional surgery (control group); whose incisions were healed in first stage. The fracture types of the enrolled patients were classified according to the AO/OTA classification [16]. This study was approved by hospital medical ethics committees and all participants gave written informed consent.
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2.2. Preoperative plan
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In order to select suitable intramedullary nail and appropriate insertion point for the experimental group, not only the size of the intramedullary nail (diameter and length) but also the distance between the insertion point of tibial intramedullary nail and the line perpendicular to the tibial plateau of the tibial tubercle were measured by the digital technology preoperatively. In the control group, conventional operation plans were conducted on the patients. Patients were examined with helical thin-slice computerized tomography (CT) scan by high speed multi-slice helical CT (slice thickness: 1.0–1.5 mm) preoperatively. The original image data with the format of Dicom were analyzed by the Mimics software (Materialise, Belgium). Combined with the Pacs system, the models of three-dimensional image were established (Fig. 1). The length, diameter and insertion point of intramedullary nail were simulated on the image workstation for the following surgery operation.
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Several studies have shown that tibial intramedullary nailing is associated with superior outcomes compared to those obtained with open reduction and internal fixation, external fixation, or nonoperative treatment in case of closed stable or unstable fractures [8,9]. Meanwhile, intramedullary nailing placement does not require a postoperative cast, and it could avoid the growth plate injury and early weight bearing with a short duration of hospitalization [10,11]. Therefore, intramedullary nailing has been widely used to address tibia fractures. However, adverse consequences may occur in the process of bone healing if the insertion point, length or diameter of intramedullary nailing is not appropriate [12]. Wang et al. have reported that the physician could precisely control surgical instruments based on a few computer-calibrated radiographic images by using computer-assisted system for distal locking of tibial intramedullary nails [13]. Moreover, the digital radiography has been used for quantitatively evaluate the tibial nail length and tibial nail designs [14, 15]. Localizing an accurate insertion point for intramedullary nailing and obtaining optimal fixation for tibial fractures based on individual differences remain as significant constraints for surgeons. In order to solve the problems that mentioned above, the clinical effects of individual placement of intramedullary nail guided by digital technique in the treatment of tibial fractures was evaluated. The size of intramedullary nail, as well as the distance between the insertion point of tibial intramedullary nail and the line perpendicular to the tibial plateau of the tibial tubercle were measured by digital technology preoperatively to select suitable intramedullary nail and appropriate insertion point. The primary aim of this study was to compare the outcomes of digitally-guided intramedullary nailing of tibial fractures to the conventional technique. Additionally, we aimed to determine whether digital guidance could reduce radiographic exposure and improve nail placement accuracy.
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Fig. 1. The images of injured leg and healthy leg (A); the simulated placement of intramedullary nail (B); the simulated insertion point (C); the length (D) and diameter (E) of the intramedullary nail; the distance between the insertion point and the line that tibial tubercle perpendicular to the tibial plateau (F) preoperatively.
2.3. Surgical procedures
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Patients with the supine position were spinal or epidural anesthetized. The patellar ligament was split or pulled outside after the incision of subcutaneous tissue was made. In the experimental group, the insertion point of intramedullary nail was found and revealed according to the distance between the insertion point of intramedullary nail and the line perpendicular to the tibial plateau of the tibial tubercle that was measured preoperatively. For the control group, the insertion point was selected at the place within about 0.5 cm below the line that tibial tubercle vertical to tibial plateau. The suitable intramedullary nail combined with connection handle and linkage of the experimental group was selected based on the diameter and length that was measured preoperatively. For the control group, the intramedullary nail was selected according to the length of guide wire entered into the medullary cavity. The nail was inserted into the medullary cavity, and the distal positioning rod and sighting device were installed with two lock pins locked in. Fractures were examined by CArm Xmedical equipment to correct rotation.
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2.4. Postoperative treatment and data collection
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Neither drainage nor external traction fixation was performed postoperatively. The patients were required to do knee and ankle joint function exercise from the first postoperative day. All of the patients
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L. Liu et al. / Clinical application for individual placement of intramedullary nail guided by digital technique Table 1 The tibial fracture types of patients in experimental group (n = 16) and control group (n = 16) by AO/OTA classification Type
A
Experimental group
Number Sum
Control group
Number Sum
A2 3
B A3 3
B1 4
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C B2 4
C1 1
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C2 1 2
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2.5. Criteria for functional evaluation
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The evaluation of functional recovery was carried out in the specialist clinic during the follow-up visits according to Johner-Wruhs’ criteria [17]. The excellent and good rates of the control group and experimental group were calculated according to the Johner-Wruh scoring one year postoperatively.
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2.6. Statistical analysis
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were followed-up periodically. The intraoperative and postoperative data of the control group and experimental group, such as operative time, number of X-ray examinations, bone healing time, distance between the actual and planned nail placement point, and postoperative lower limb alignment were recorded.
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3. Results
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Thirty-two cases treated with individual placement of intramedullary nail guided by digital technique (experimental group, n = 16) or conventional surgery (control group, n = 16) were collected, including 18 males and 14 females with an average age of 43 (range: 19–69 years). There was no significant difference in the age (43 ± 3.1 years vs. 42 ± 2.5 years) and gender between the experimental group and control group (P < 0.05). There were 21 cases of traffic accident-fractures, 7 cases of fall downfractures and 4 cases of other type-fractures. According to the AO/OTA classification, there were 6 cases of type A-fractures, 8 cases of type B-fractures and 2 cases of type C-fractures in the experimental group. In the control group, there were 5 cases of type A-fractures, 9 cases of type B-fractures and 2 cases of type C-fractures (Table 1). We performed emergency surgery on 15 patients including 7 patients in the experimental group and 8 patients in the control group. The other 17 patients received surgery within the average time of 4 days (range: 3–7 days) after admission. After 8–15 months follow-up visits of the 32 cases, none of the patients was bone nonunion and the average bone healing time was 16.1 ± 1.2 weeks (range: 13–41 weeks). The Johner-Wruh scoring one year postoperatively showed that the surgery results were excellent in 13 cases, good in 3 cases of the experimental group; excellent in 9 cases, good in 5 cases, fair in 1 case and bad in 1 case of the control
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The results were expressed as mean ± standard deviation (SD) and statistical analysis was performed by the SPSS version 13.0 statistical software (SPSS, Chicago, IL). All of the measurement data between the two groups were analyzed by the T-test. The Pearson correlation coefficient was used to indicate the correlation. Multiple-factor analysis was performed using the multiple stepwise regression method. There is significantly statistical difference when P < 0.05.
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Table 2 The Johner-Wruh scoring of the experimental and control group one year postoperatively Groups Bone nonunion/ostitis/amputation Neurovascular injury Introversion/extroversion Forward/back into a corner Rotation Shortening Range of motionin the knees Range of motion in ankle joint Range of motion in subtalar joint Pain Gait Weight-bearing ability Total
Experimental group Excellent Good Fair 16 0 0 16 0 0 16 0 0 16 0 0 16 0 0 16 0 0 13 3 0 14 2 0 14 2 0 13 3 0 14 2 0 14 2 0 13 3 0
Bad 0 0 0 0 0 0 0 0 0 0 0 0 0
Excellent 16 16 14 14 14 16 9 11 11 10 10 10 9
Control group Good Fair 0 0 0 0 1 1 2 0 1 1 0 0 5 1 4 1 4 1 4 1 4 1 4 1 5 1
Bad 0 0 0 0 0 0 1 0 0 1 1 1 1
Experimental group 16 43.1 ± 6.2 5 ± 0.4 15.5 ± 1.1 1.4 ± 0.2 16 100
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Control group 16 48.7 ± 8.3 11 ± 2.6 16.7 ± 2.4 4.3 ± 0.7 15 87.50
P-value − > 0.05 < 0.05 > 0.05 < 0.05 > 0.05 −
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Data Number of Cases Operative time (min) Fluoroscopy times Bone healing time (week) Distance between the actual and planned insertion point (mm) Good postoperative lower limb alignment (case) Excellent and good rate (%)
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Table 3 The intraoperative and postoperative data of the control group and experimental group
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4. Discussion
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The technique of three-dimensional reconstruction based on high-resolution spiral CT scans plays an important role in modern clinical application, and it could be used to evaluate bone status for fractures diagnosis and characterization, and bone quality assessment [18–21]. This study was performed to evaluate the clinical treatment effects of individual placement of intramedullary nail guided by digital technique in the treatment of tibial fractures. In the current study, we found that the number of X-ray examinations and distance between the actual and planned nail placement point of the experimental group were significantly reduced than those of the control group (P < 0.05). Furthermore, the excellent and good rate of the experimental group and control group was 100% and 87.50% respectively. Recently, flexible intramedullary nailing has become the preferred method for the treatment of tibial shaft fractures that require operative fixation [22–24]. The application and development of digital
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group (Table 2). The excellent and good rate of the experimental and control group was 100% (16/16) and 87.50% (14/16) respectively. The operative time (43.1 ± 6.2 min vs. 48.7 ± 8.3 min, P > 0.05), bone healing time (15.5 ± 1.1 weeks vs. 16.7 ± 2.4 weeks, P > 0.05) and number of cases with good postoperative lower limb alignment (16 vs. 15, P > 0.05) did not change significantly between the experimental and control group (Table 3). There were statistically significant differences in number of X-ray examinations (5 ± 0.4 vs. 11 ± 2.6, P < 0.05) and the distance between the actual and the planned nail placement point (1.4 ± 0.2 mm vs. 4.3 ± 0.7 mm, P < 0.05) between experimental group and control group (Table 3).
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Acknowledgements
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This study was supported by Shanghai medical key subject construction project (ZK2012A28) and National Clinical key specialty construction project.
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References
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orthopaedic technology contribute to the tibial fractures intramedullary nail individual placement [25– 27]. In order to select suitable intramedullary nail and appropriate insertion point for patients treated with individual placement of intramedullary nail guided by digital technique, the length and diameter of intramedullary nail, as well as the distance between the insertion point of tibial intramedullary nail and the line perpendicular to the tibial plateau of the tibial tubercle were measured preoperatively. The three-dimension images, morphological and topological information could be characterized by several image-analysis tools with practicability and high accuracy [28,29]. Therefore, the three-dimension images of bilateral tibia, appropriate length and diameter of the intramedullary nail, and accurate insertion point for the patients could be obtained by modeling technique of digital orthopedics preoperatively. These might be the reasons for fewer numbers of X-ray examinations, decreased distance between the actual and planned nail placement point, and similar excellent and good rate of the experimental group. However, there are some limitations in our study: the sample size is not large enough; the clinical treatment effects of individual placement of intramedullary nail guided by digital technique in other different kinds of complex bone fractures are not evaluated. In conclusion, our results showed that individual placement of intramedullary nail guided by digital technique in tibial fractures has some advantages, such as fewer numbers of X-ray examinations, decreased distance between the actual and planned insertion point of intramedullary nail, similar outcomes. Therefore, the individual placement of intramedullary nail guided by digital technique in tibial fractures might have good clinical effects and is worthy of widely used. However, the individual placement of intramedullary nail guided by digital technique still need to be further explored and researched. In our next study, we will consider building a multiple linear regression or multiple logistic regression model taking into account age, body mass index, gender, fracture classification, time to surgery, and any other possible confounder we have measured. In particular, limitations of our study exist in that a number of parameters were not considered in our study, such as age, body mass index, gender, fracture classification, time to surgery. Since the influence of these characteristics might be of interest, they should be included in future investigations.
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Fortis AP, Dimas A, Lamprakis AA. Expandable nailing system for tibial shaft fractures. Injury. 2008; 39(8): 940. Alho A, Benterud JG, Hogevold HE, Ekeland A, Stromsoe K. Comparison of functional bracing and locked intramedullary nailing in the treatment of displaced tibial shaft fractures. Clin Orthop Relat Res. 1992; 277: 243. Whittle AP, Russell TA, Taylor JC, Lavelle DG. Treatment of open fractures of the tibial shaft with the use of interlocking nailing without reaming. J Bone Joint Surg Am. 1992; 74(8): 1162. Wahnert D, Stolarczyk Y, Hoffmeier KL, Raschke MJ, Hofmann GO, Muckley T. Long-term stability of angle-stable versus conventional locked intramedullary nails in distal tibia fractures. BMC Musculoskelet Disord. 2013; 14: 66. Tanna DD. Interlocking tibial nailing without an image intensifier. J Bone Joint Surg Br. 1994; 76(4): 670. Lam SW, Teraa M, Leenen LP, van der Heijden GJ. Systematic review shows lowered risk of nonunion after reamed nailing in patients with closed tibial shaft fractures. Injury. 2010; 41(7): 671. Koo H, Hupel T, Zdero R, Tov A, Schemitsch EH. The effect of muscle contusion on cortical bone and muscle perfusion following reamed, intramedullary nailing: A novel canine tibia fracture model. J Orthop Surg Res. 2010; 5: 89.
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Weninger P, Tschabitscher M, Traxler H, Pfafl V, Hertz H. Intramedullary nailing of proximal tibia fractures–an anatomical study comparing three lateral starting points for nail insertion. Injury. 2010; 41(2): 220. Puloski S, Romano C, Buckley R, Powell J. Rotational malalignment of the tibia following reamed intramedullary nail fixation. J Orthop Trauma. 2004; 18(7): 397. Ligier JN, Metaizeau JP, Prevot J. [Closed flexible medullary nailing in pediatric traumatology]. Chir Pediatr. 1983; 24(6): 383. Griffet J, Leroux J, Boudjouraf N, Abou-Daher A, El Hayek T. Elastic stable intramedullary nailing of tibial shaft fractures in children. J Child Orthop. 2011; 5(4): 297. Morandi M, Banka T, Gaiarsa GP, Guthrie ST, Khalil J, Hoegler J et al. Intramedullary nailing of tibial fractures: review of surgical techniques and description of a percutaneous lateral suprapatellar approach. Orthopedics. 2010; 33(3): 172. Wang J, Zhao C, Wang M, Su Y, Hu L, Sun L et al. Computer-assisted auto-frame navigation system for distal locking of tibial intramedullary nails: A preliminary report on clinical application. Chinese journal of traumatology = Zhonghua chuang shang za zhi/Chinese Medical Association. 2006; 9(3): 138. Schmutz B, Rathnayaka K, Wullschleger M, Meek J, Schuetz M. Quantitative fit assessment of tibial nail designs using 3D computer modelling. Injury. 2010; 41(2): 216. France MA, Koval KJ, Hiebert R, Tejwani N, McLaurin TM, Egol KA. Preoperative assessment of tibial nail length: accuracy using digital radiography. Orthopedics. 2006; 29(7): 623. Schatzker J, McBroom R, Bruce D. The tibial plateau fracture. The Toronto experience 1968–1975. Clin Orthop Relat Res. 1979; 138: 94. Johner R, Wruhs O. Classification of tibial shaft fractures and correlation with results after rigid internal fixation. Clin Orthop Relat Res. 1983; 178: 7. Jun BC, Song SW, Cho JE, Park CS, Lee DH, Chang KH et al. Three-dimensional reconstruction based on images from spiral high-resolution computed tomography of the temporal bone: anatomy and clinical application. J Laryngol Otol. 2005; 119(9): 693. Rose EH, Norris MS, Rosen JM. Application of high-tech three-dimensional imaging and computer-generated models in complex facial reconstructions with vascularized bone grafts. Plast Reconstr Surg. 1993; 91(2): 252. D’Elia G, Caracchini G, Cavalli L, Innocenti P. Bone fragility and imaging techniques. Clin Cases Miner Bone Metab. 2009; 6(3): 234. Lopes PM, Moreira CR, Perrella A, Antunes JL, Cavalcanti MG. 3-D volume rendering maxillofacial analysis of angular measurements by multislice CT. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008; 105(2): 224. Sankar WN, Jones KJ, David Horn B, Wells L. Titanium elastic nails for pediatric tibial shaft fractures. J Child Orthop. 2007; 1(5): 281. Gordon JE, Gregush RV, Schoenecker PL, Dobbs MB, Luhmann SJ. Complications after titanium elastic nailing of pediatric tibial fractures. J Pediatr Orthop. 2007; 27(4): 442. O’Brien T, Weisman DS, Ronchetti P, Piller CP, Maloney M. Flexible titanium nailing for the treatment of the unstable pediatric tibial fracture. J Pediatr Orthop. 2004; 24(6): 601. Muller R, Hildebrand T, Ruegsegger P. Non-invasive bone biopsy: A new method to analyse and display the threedimensional structure of trabecular bone. Phys Med Biol. 1994; 39(1): 145. Ruegsegger P, Koller B, Muller R. A microtomographic system for the nondestructive evaluation of bone architecture. Calcif Tissue Int. 1996; 58(1): 24. Feldkamp LA, Goldstein SA, Parfitt AM, Jesion G, Kleerekoper M. The direct examination of three-dimensional bone architecture in vitro by computed tomography. J Bone Miner Res. 1989; 4(1): 3. Pothuaud L, Benhamou CL, Porion P, Lespessailles E, Harba R, Levitz P. Fractal dimension of trabecular bone projection texture is related to three-dimensional microarchitecture. J Bone Miner Res. 2000; 15(4): 691. Regensburg NI, Kok PH, Zonneveld FW, Baldeschi L, Saeed P, Wiersinga WM et al. A new and validated CT-based method for the calculation of orbital soft tissue volumes. Invest Ophthalmol Vis Sci. 2008; 49(5): 1758.
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Technology and Health Care 00 (2014) 1–7 DOI 10.3233/THC-140930 IOS Press
1
2
3
4 5
Clinical application for individual placement of intramedullary nail guided by digital technique in tibial fractures Lin Liua,1 , Xian Xua,1 , Xu Lia , Wei Wua , Junfeng Caib and Qingyou Lua,∗ a Department
b Department
of Trauma Surgery, East Hospital Affiliated to Tongji University, Shanghai, China of Joint Surgery, East Hospital Affiliated to Tongji University, Shanghai, China
8
Received 28 February 2014 Accepted 22 May 2014
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si o
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Keywords: Digital, tibial fractures, intramedullary nail, individual
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1. Introduction
25
Tibial fractures are the most common and serious long bone fractures, due to their potential for malunion, nonunion, long-term dysfunction and open injury [1,2]. Intramedullary nailing has become the standard treatment method for closed and most of the open fractures of the long-bone diaphysis (such as displaced/unstable tibial shaft fractures), because it provides a high mechanical stability and can be performed in a minimally invasive manner [3–7].
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Abstract. BACKGROUND: To evaluate the clinical effects of individual placement of intramedullary nail guided by digital technique in the treatment of tibial fractures. METHODS: Thirty-two cases of unilateral tibial fractures treated with individual placement of intramedullary nail guided by digital technique or conventional surgery were collected from October 2010 to October 2012. In the experimental group, the size of intramedullary nail, as well as the distance between the insertion point of tibial intramedullary nail and the line perpendicular to the tibial plateau of the tibial tubercle were measured by digital technology preoperatively to select suitable intramedullary nail and appropriate insertion point. RESULTS: The operative time and bone healing time of the experimental group didn’t change significantly (P > 0.05). There were statistically significant differences in the number of X-ray examinations and the distance between actual and planned nail placement point between experimental group and control group. The excellent and good rate of functional recovery for the experimental and the control group was 100% and 87.50%, respectively. CONCLUSION: Compared with the conventional surgery, individual placement of intramedullary nail guided by digital technique in tibial fractures might have superior outcomes.
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Lin Liu and Xian Xu should be regarded as co-first authors. Corresponding author: Qingyou Lu, Department of Trauma Surgery, East Hospital Affiliated to Tongji University, Shanghai 200120, China. Tel.: +86 13816521820; E-mail: [email protected]. ∗
c 2014 – IOS Press and the authors. All rights reserved 0928-7329/14/$27.50
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2. Materials and methods
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2.1. Study population
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From October 2010 to October 2012, patients were collected according to the following criteria: with unilateral tibial fractures; treated with individual placement of intramedullary nail guided by digital technique (experimental group) or conventional surgery (control group); whose incisions were healed in first stage. The fracture types of the enrolled patients were classified according to the AO/OTA classification [16]. This study was approved by hospital medical ethics committees and all participants gave written informed consent.
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2.2. Preoperative plan
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In order to select suitable intramedullary nail and appropriate insertion point for the experimental group, not only the size of the intramedullary nail (diameter and length) but also the distance between the insertion point of tibial intramedullary nail and the line perpendicular to the tibial plateau of the tibial tubercle were measured by the digital technology preoperatively. In the control group, conventional operation plans were conducted on the patients. Patients were examined with helical thin-slice computerized tomography (CT) scan by high speed multi-slice helical CT (slice thickness: 1.0–1.5 mm) preoperatively. The original image data with the format of Dicom were analyzed by the Mimics software (Materialise, Belgium). Combined with the Pacs system, the models of three-dimensional image were established (Fig. 1). The length, diameter and insertion point of intramedullary nail were simulated on the image workstation for the following surgery operation.
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Several studies have shown that tibial intramedullary nailing is associated with superior outcomes compared to those obtained with open reduction and internal fixation, external fixation, or nonoperative treatment in case of closed stable or unstable fractures [8,9]. Meanwhile, intramedullary nailing placement does not require a postoperative cast, and it could avoid the growth plate injury and early weight bearing with a short duration of hospitalization [10,11]. Therefore, intramedullary nailing has been widely used to address tibia fractures. However, adverse consequences may occur in the process of bone healing if the insertion point, length or diameter of intramedullary nailing is not appropriate [12]. Wang et al. have reported that the physician could precisely control surgical instruments based on a few computer-calibrated radiographic images by using computer-assisted system for distal locking of tibial intramedullary nails [13]. Moreover, the digital radiography has been used for quantitatively evaluate the tibial nail length and tibial nail designs [14, 15]. Localizing an accurate insertion point for intramedullary nailing and obtaining optimal fixation for tibial fractures based on individual differences remain as significant constraints for surgeons. In order to solve the problems that mentioned above, the clinical effects of individual placement of intramedullary nail guided by digital technique in the treatment of tibial fractures was evaluated. The size of intramedullary nail, as well as the distance between the insertion point of tibial intramedullary nail and the line perpendicular to the tibial plateau of the tibial tubercle were measured by digital technology preoperatively to select suitable intramedullary nail and appropriate insertion point. The primary aim of this study was to compare the outcomes of digitally-guided intramedullary nailing of tibial fractures to the conventional technique. Additionally, we aimed to determine whether digital guidance could reduce radiographic exposure and improve nail placement accuracy.
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Fig. 1. The images of injured leg and healthy leg (A); the simulated placement of intramedullary nail (B); the simulated insertion point (C); the length (D) and diameter (E) of the intramedullary nail; the distance between the insertion point and the line that tibial tubercle perpendicular to the tibial plateau (F) preoperatively.
2.3. Surgical procedures
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Patients with the supine position were spinal or epidural anesthetized. The patellar ligament was split or pulled outside after the incision of subcutaneous tissue was made. In the experimental group, the insertion point of intramedullary nail was found and revealed according to the distance between the insertion point of intramedullary nail and the line perpendicular to the tibial plateau of the tibial tubercle that was measured preoperatively. For the control group, the insertion point was selected at the place within about 0.5 cm below the line that tibial tubercle vertical to tibial plateau. The suitable intramedullary nail combined with connection handle and linkage of the experimental group was selected based on the diameter and length that was measured preoperatively. For the control group, the intramedullary nail was selected according to the length of guide wire entered into the medullary cavity. The nail was inserted into the medullary cavity, and the distal positioning rod and sighting device were installed with two lock pins locked in. Fractures were examined by CArm Xmedical equipment to correct rotation.
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2.4. Postoperative treatment and data collection
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Neither drainage nor external traction fixation was performed postoperatively. The patients were required to do knee and ankle joint function exercise from the first postoperative day. All of the patients
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L. Liu et al. / Clinical application for individual placement of intramedullary nail guided by digital technique Table 1 The tibial fracture types of patients in experimental group (n = 16) and control group (n = 16) by AO/OTA classification Type
A
Experimental group
Number Sum
Control group
Number Sum
A2 3
B A3 3
B1 4
2
4
6 3
C B2 4
C1 1
5
1
8
5
C2 1 2
9
1 2
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2.5. Criteria for functional evaluation
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The evaluation of functional recovery was carried out in the specialist clinic during the follow-up visits according to Johner-Wruhs’ criteria [17]. The excellent and good rates of the control group and experimental group were calculated according to the Johner-Wruh scoring one year postoperatively.
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2.6. Statistical analysis
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were followed-up periodically. The intraoperative and postoperative data of the control group and experimental group, such as operative time, number of X-ray examinations, bone healing time, distance between the actual and planned nail placement point, and postoperative lower limb alignment were recorded.
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3. Results
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Thirty-two cases treated with individual placement of intramedullary nail guided by digital technique (experimental group, n = 16) or conventional surgery (control group, n = 16) were collected, including 18 males and 14 females with an average age of 43 (range: 19–69 years). There was no significant difference in the age (43 ± 3.1 years vs. 42 ± 2.5 years) and gender between the experimental group and control group (P < 0.05). There were 21 cases of traffic accident-fractures, 7 cases of fall downfractures and 4 cases of other type-fractures. According to the AO/OTA classification, there were 6 cases of type A-fractures, 8 cases of type B-fractures and 2 cases of type C-fractures in the experimental group. In the control group, there were 5 cases of type A-fractures, 9 cases of type B-fractures and 2 cases of type C-fractures (Table 1). We performed emergency surgery on 15 patients including 7 patients in the experimental group and 8 patients in the control group. The other 17 patients received surgery within the average time of 4 days (range: 3–7 days) after admission. After 8–15 months follow-up visits of the 32 cases, none of the patients was bone nonunion and the average bone healing time was 16.1 ± 1.2 weeks (range: 13–41 weeks). The Johner-Wruh scoring one year postoperatively showed that the surgery results were excellent in 13 cases, good in 3 cases of the experimental group; excellent in 9 cases, good in 5 cases, fair in 1 case and bad in 1 case of the control
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The results were expressed as mean ± standard deviation (SD) and statistical analysis was performed by the SPSS version 13.0 statistical software (SPSS, Chicago, IL). All of the measurement data between the two groups were analyzed by the T-test. The Pearson correlation coefficient was used to indicate the correlation. Multiple-factor analysis was performed using the multiple stepwise regression method. There is significantly statistical difference when P < 0.05.
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Table 2 The Johner-Wruh scoring of the experimental and control group one year postoperatively Groups Bone nonunion/ostitis/amputation Neurovascular injury Introversion/extroversion Forward/back into a corner Rotation Shortening Range of motionin the knees Range of motion in ankle joint Range of motion in subtalar joint Pain Gait Weight-bearing ability Total
Experimental group Excellent Good Fair 16 0 0 16 0 0 16 0 0 16 0 0 16 0 0 16 0 0 13 3 0 14 2 0 14 2 0 13 3 0 14 2 0 14 2 0 13 3 0
Bad 0 0 0 0 0 0 0 0 0 0 0 0 0
Excellent 16 16 14 14 14 16 9 11 11 10 10 10 9
Control group Good Fair 0 0 0 0 1 1 2 0 1 1 0 0 5 1 4 1 4 1 4 1 4 1 4 1 5 1
Bad 0 0 0 0 0 0 1 0 0 1 1 1 1
Experimental group 16 43.1 ± 6.2 5 ± 0.4 15.5 ± 1.1 1.4 ± 0.2 16 100
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Control group 16 48.7 ± 8.3 11 ± 2.6 16.7 ± 2.4 4.3 ± 0.7 15 87.50
P-value − > 0.05 < 0.05 > 0.05 < 0.05 > 0.05 −
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Data Number of Cases Operative time (min) Fluoroscopy times Bone healing time (week) Distance between the actual and planned insertion point (mm) Good postoperative lower limb alignment (case) Excellent and good rate (%)
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Table 3 The intraoperative and postoperative data of the control group and experimental group
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4. Discussion
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The technique of three-dimensional reconstruction based on high-resolution spiral CT scans plays an important role in modern clinical application, and it could be used to evaluate bone status for fractures diagnosis and characterization, and bone quality assessment [18–21]. This study was performed to evaluate the clinical treatment effects of individual placement of intramedullary nail guided by digital technique in the treatment of tibial fractures. In the current study, we found that the number of X-ray examinations and distance between the actual and planned nail placement point of the experimental group were significantly reduced than those of the control group (P < 0.05). Furthermore, the excellent and good rate of the experimental group and control group was 100% and 87.50% respectively. Recently, flexible intramedullary nailing has become the preferred method for the treatment of tibial shaft fractures that require operative fixation [22–24]. The application and development of digital
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group (Table 2). The excellent and good rate of the experimental and control group was 100% (16/16) and 87.50% (14/16) respectively. The operative time (43.1 ± 6.2 min vs. 48.7 ± 8.3 min, P > 0.05), bone healing time (15.5 ± 1.1 weeks vs. 16.7 ± 2.4 weeks, P > 0.05) and number of cases with good postoperative lower limb alignment (16 vs. 15, P > 0.05) did not change significantly between the experimental and control group (Table 3). There were statistically significant differences in number of X-ray examinations (5 ± 0.4 vs. 11 ± 2.6, P < 0.05) and the distance between the actual and the planned nail placement point (1.4 ± 0.2 mm vs. 4.3 ± 0.7 mm, P < 0.05) between experimental group and control group (Table 3).
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Acknowledgements
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This study was supported by Shanghai medical key subject construction project (ZK2012A28) and National Clinical key specialty construction project.
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References
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orthopaedic technology contribute to the tibial fractures intramedullary nail individual placement [25– 27]. In order to select suitable intramedullary nail and appropriate insertion point for patients treated with individual placement of intramedullary nail guided by digital technique, the length and diameter of intramedullary nail, as well as the distance between the insertion point of tibial intramedullary nail and the line perpendicular to the tibial plateau of the tibial tubercle were measured preoperatively. The three-dimension images, morphological and topological information could be characterized by several image-analysis tools with practicability and high accuracy [28,29]. Therefore, the three-dimension images of bilateral tibia, appropriate length and diameter of the intramedullary nail, and accurate insertion point for the patients could be obtained by modeling technique of digital orthopedics preoperatively. These might be the reasons for fewer numbers of X-ray examinations, decreased distance between the actual and planned nail placement point, and similar excellent and good rate of the experimental group. However, there are some limitations in our study: the sample size is not large enough; the clinical treatment effects of individual placement of intramedullary nail guided by digital technique in other different kinds of complex bone fractures are not evaluated. In conclusion, our results showed that individual placement of intramedullary nail guided by digital technique in tibial fractures has some advantages, such as fewer numbers of X-ray examinations, decreased distance between the actual and planned insertion point of intramedullary nail, similar outcomes. Therefore, the individual placement of intramedullary nail guided by digital technique in tibial fractures might have good clinical effects and is worthy of widely used. However, the individual placement of intramedullary nail guided by digital technique still need to be further explored and researched. In our next study, we will consider building a multiple linear regression or multiple logistic regression model taking into account age, body mass index, gender, fracture classification, time to surgery, and any other possible confounder we have measured. In particular, limitations of our study exist in that a number of parameters were not considered in our study, such as age, body mass index, gender, fracture classification, time to surgery. Since the influence of these characteristics might be of interest, they should be included in future investigations.
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