A prospective randomized study of operative treatment for noncomminuted humeral shaft fractures: conventional open plating versus minimal invasive plate osteosynthesis.

ORIGINAL ARTICLE

A Prospective Randomized Study of Operative Treatment for Noncomminuted Humeral Shaft Fractures: Conventional Open Plating Versus Minimal Invasive Plate Osteosynthesis Ji Wan Kim, MD,* Chang-Wug Oh, MD,† Young-Soo Byun, MD,‡ Jung Jae Kim, MD,§ and Ki Chul Park, MDk

Objectives: To compare the clinical and radiologic results of conventional open plating (COP) and minimally invasive plate osteosynthesis (MIPO) in the treatment of noncomminuted humeral shaft fractures.

Design: Randomized prospective study. Setting: Five level 1 trauma centers. Patients: Sixty-eight consecutive patients were randomized into 2 study groups: those treated by COP (COP group; n = 32) and those treated by MIPO (MIPO group; n = 36). Intervention: Simple humeral shaft fractures (AO/OTA classification types A and B) were reduced by open reduction or closed reduction and fixed with a narrow 4.5/5.0 locking compression plate, metaphyseal locking compression plate, or proximal humeral internal locking system plate to the anterior lateral aspect of the humerus.

Main Outcome Measurements: Fracture healing time, operative time, radiation exposure time, and intraoperative nerve injury. To assess shoulder and elbow function, we used the University of California, Los Angeles (UCLA) scoring system and the Mayo elbow performance index, including the range of motion and pain. Radiographic measurements included fracture alignment, delayed union, and nonunion. Results: Thirty-one fractures (97%) healed in the COP group within 16 weeks, whereas 36 fractures (100%) were healed in the MIPO group by 15 weeks. No significant difference was observed in Accepted for publication August 19, 2014. From the *Department of Orthopaedic Surgery, Haeundae Paik Hospital, Inje University, Busan, Korea; †Department of Orthopaedic Surgery, Kyungpook National University Hospital, Daegu, Korea; ‡Department of Orthopaedic Surgery, Daegu Fatima Hospital, Daegu, Korea; §Department of Orthopaedic Surgery, Asan Medical Center, University of Ulsan, Seoul, Korea; and kDepartment of Orthopaedic Surgery, Hanyang University Guri Hospital, Hanyang University, Guri, Korea. Supported by the AO Trauma Asia Pacific Research Grants. Presented at the Annual Meeting of the Orthopaedic Trauma Association, October 12, 2013, Phoenix, AZ. The authors report no conflict of interest. Reprints: Ki Chul Park, MD, Hanyang University Guri Hospital, Hanyang University, 249-1, Gyomoon-dong, Guri, Korea 471-701 (e-mail: kcpark@ hanyang.ac.kr). Copyright © 2014 Wolters Kluwer Health, Inc. All rights reserved.

J Orthop Trauma Volume 29, Number 4, April 2015

the operative time or complication rates. In both groups, all fractures achieved union without malunion and with excellent functional outcomes by definition of the Mayo elbow performance index and UCLA scoring system.

Conclusions: This study confirmed a high overall rate of union and excellent functional outcomes in both MIPO and COP groups. MIPO is equivalent to COP as a safe and effective method for simple types of humeral shaft fractures when surgery is indicated, and the surgeon is experienced in the technique. Key Words: humerus, humeral shaft fracture, plate osteosynthesis, ORIF, MIPO, trauma

Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. (J Orthop Trauma 2015;29:189–194)

INTRODUCTION Most of isolated humeral shaft fractures can be treated successfully with a functional brace.1–3 Specific operative indications include (1) fractures in polytrauma patients, (2) segmental fractures, (3) pathologic fractures, (4) bilateral fractures, (5) open fractures, and (6) in cases of neurovascular compromise.4–6 Moreover, Sarmiento et al3 have reported that angular deformity after the use of a functional brace was more likely to occur in association with transverse fractures. Other authors have noted a relative propensity for delayed union or higher nonunion rates in transverse and short oblique fractures managed nonoperatively in an active individual,1,7 and considered such injuries to be a relative surgical indication.8 These fractures can be surgically treated by either plating or nailing; however, the recent literature has reported that plating is more popular than nailing because of the higher complication rates and technical difficulty associated with the latter method.9,10 Conventional open plating (COP) has the advantage of anatomical reduction but also has a variety of disadvantages, including potential injury to the radial nerve, the risk of infection and nonunion caused by extensive soft tissue stripping, and disruption of the periosteal blood supply.11 Minimally invasive plate osteosynthesis (MIPO) has the potential to minimize the complications of an open reduction www.jorthotrauma.com |

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Kim et al

including infection,12–15 and several authors have reported that MIPO of humeral shaft fractures is a safe and effective method.13,16,17 However, these studies did not report the results according to the fracture classification. Hence, evidence is lacking about the results of MIPO for simple types of humeral shaft fractures. In addition, no consensus has been reached based on prospectively designed and randomized studies that those of these fixation methods are superior for stabilizing simple types of humeral shaft fractures. To properly assess whether COP or MIPO is the better procedure in terms of function and fracture healing would require a large number of patients. Because of the limitations in participants, this study has a more modest goal: to determine whether there is a difference in the complication rates of the 2 procedures. Radiographic and functional outcomes were assessed secondarily. The purpose of the present study was to compare the complication rates and determine the level of safety of open plating and MIPO in the treatment of simple types of humeral shaft fractures.

FIGURE 1. Flowchart of the selection process for the study population.

We calculated the required sample size of this randomized controlled study using the previously published 0% of the complication rate of the MIPO technique, which was reported by Zuiquan et al in 201014 and 25% of the complication rate of open reduction and internal fixation (ORIF) by Changulani in 2007.18 Based on a power of 80%, significance level of 5%, the inclusion of 26 patients in each group is estimated as an optimal sample size. As we expected a dropout rate of 20% during follow-up, we planned to include 33 patients in the each group. All operations were performed by surgeons with more than 10 years of experience in orthopaedic traumatology. The criteria used for selection were as follows: (1) simple humeral shaft fractures (AO/OTA classification19 types A and B), which occurred in 37 multiple trauma patients (54%), 12 patients with transverse fractures (18%), and 19 patients (28%) who wanted to return to work as soon as possible after surgical treatment instead of undergoing conservative treatment, including 9 athletes; (2) humeral shaft fractures located at least 3 cm distal to the surgical neck and at least 5 cm proximal to the olecranon fossa; and (3) an age older than 15 years and the completion of bone growth. Comminuted humeral shaft fractures (AO/OTA classification C), pathologic fractures, Gustilo–Anderson grade III open fractures,20 and refusal to participate in the randomized study were the exclusion criteria (Fig. 1). This study was approved by the institutional review board, and informed consent was obtained from the patients. From March 2010 to December 2011, 87 patients presented consecutively to 5 different level 1 trauma centers with simple humeral shaft fractures requiring surgical stabilization, and 15 patients refused the study. The 72 patients who were enrolled were randomized into 2 groups, but only 68 were used in the analysis because 4 patients in the ORIF group were lost to follow-up: of this, we had 32 fractures in the COP group and 36 in the MIPO group (Fig. 1). The randomization was performed with blocked randomization, and notification of the surgical method was conducted before the surgery by a phone

call to a coordinator. All patients had an average follow-up of 15 months, with a minimum follow-up of 12 months. The 68 patients (37 male patients and 31 female patients) included in the study had an average age of 42 years (range, 15–86 years). There were 4 open fractures (COP group, n = 1; MIPO group, n = 3). No significant difference was observed in the patient demographics and the injury characteristics between the 2 groups (Table 1). For both groups, a locking compression plate (LCP) (5.0 narrow LCP, metaphyseal LCP, proximal humeral internal locking system plate; Synthes, Oberdorf, Switzerland) was used depending on the fracture site. The choice of plate was essentially determined based on the fracture site but was left to the discretion of the treating surgeon. A minimum of 6 cortices of purchase was obtained for bone fixation on each side of the fracture. The surgical technique for the COP group involved an anterolateral approach in a supine position and the arm on a radiolucent board. Basic fracture principles were followed, and reduction was achieved by opening the fracture site with a minimum of soft tissue stripping. We attempted to obtain absolute stability for types A and B fractures using dynamic compression or the lag screw technique. Twenty-three 5.0 narrow LCP and 9 metaphyseal LCP were used for fracture stabilization. In the MIPO group, the patients were also placed in a supine position and the arm on a radiolucent board (Fig. 2). For the deltopectoral approach, a proximal incision approximately 3 cm in length was made between the proximal biceps brachialis muscle medially and the deltoid muscle laterally. Dissection was then performed down to bone, where the anterior border of the humerus distal to the crest of the greater tuberosity was identified through the delto-bicipital interval. A distal incision of 3–5 cm was made on the anterior surface, midline, and 3–4 cm proximal to the elbow crease. The lateral antebrachial cutaneous nerve was usually identified and protected after retracting the biceps muscle. A subbrachialis extraperiosteal tunnel was made with a blunt dissection using a periosteal elevator from the proximal to distal window. Under image intensifier control, the reduction was achieved

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PATIENTS AND METHODS

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Open plating vs MIPO for simple humeral shaft fractures

FIGURE 2. A, A 21-year-old woman sustained a fracture of the left humeral shaft (AO/OTA 12-A3) after a fall. B, The fracture was treated by MIPO. C, Under the image intensifier, the reduction state was verified. D, Postoperative radiographs show an acceptable alignment. E, The fracture was healed with callus formation 4 months after surgery, with a small incision scar and satisfactory function (F). Editor’s note: A color image accompanies the online version of this article.

by 1 of 2 methods, depending on the difficulty of the reduction maneuver. In the first method, reduction was achieved by manual traction, and an additional external fixator was sometimes used to maintain the reduction. A provisional external fixator was used in 15% of patients because of surgeon’s preference. When applying external fixator, 4.0- or 5.0-mm proximal Schanz pin was inserted at the lateral aspect of the humerus. The level of a Schanz screw was within 6 cm from the acromion to avoid axillary nerve damage. As the radial nerve may be at risk in the distal humerus, 1 distal Schanz pin was fixed at the level of the lateral epicondyle. In the second method, a plate was fixed to a short fragment along with the long axis of the humerus shaft before reduction; the fracture was reduced by manual traction and subsequently fixed with screws to the opposite side of the humerus. The plate was fixed on the anterior surface of the humeral shaft. The plates used were the narrow LCP (n = 26), metaphyseal LCP (n = 7), and proximal humeral internal locking system plate (n = 3). Copyright Ó 2014 Wolters Kluwer Health, Inc. All rights reserved.

All open fractures were stabilized after irrigation and thorough debridement of the open wound, and the drainage bag was retained after surgery. No cast or brace was used postoperatively in either group. Shoulder and elbow range of motion (ROM) was initiated as soon as possible. Follow-up with clinical examination and anteroposterior and lateral radiographs were performed at 2, 4, 8, 12, 16, and 20 weeks postoperatively. Further radiographs were obtained depending on the healing status. The outcome measurements included radiographic fracture healing, function, and complications. The clinical assessment was evaluated postoperatively at 6 months, which included neurologic evaluation, shoulder and elbow function (UCLA scoring system,21 and Mayo elbow performance index22), including ROM and pain. Radiographic measurements included fracture alignment, time to healing, and nonunion. Radiographic bone union was defined as cortical continuity and obliteration of the fracture line in the COP group and the presence of bonewww.jorthotrauma.com |

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TABLE 1. Patient Demographics and Fracture Characteristics Age (y) Sex Male Female BMI, kg/m2 Smoking, n (%) DM, n (%) Fracture location Proximal Middle Distal AO-OTA classification Type A A1 A2 A3 Type B B1 B2 B3 Gustilo–Anderson classification Grade I Grade II Preoperative radial nerve palsy

COP (n = 32)

MIPO (n = 36)

P

44.4 (17–84)

40.6 (15–86)

0.411 0.774

18 14 24.3 (18–35) 9 (28) 2 (6.2)

19 17 22.9 (14–31) 9 (25) 3 (8.3)

4 16 12

4 21 11

21 8 3 10 11 6 4 1

19 3 4 12 17 5 8 4

0.104 0.772 0.744 0.784

0.346

0.366 1 0 3

1 2 4

0.631

Patient demographics and fracture characteristics were similar in 2 groups of treatment. BMI, body mass index; DM, diabetes mellitus.

bridging callus in at least 3 cortices in 2 planes in the MIPO group. Fracture healing in COP is primary bone healing without callus formation, whereas MIPO is secondary bone healing with callus formation. The radiographic criteria of these 2 methods are substantially different. All of the radiographic observations in the current study were conducted by an orthopaedic surgeon. Although the union time was also evaluated, the study focused more on the objective end point of delayed union or nonunion requiring another intervention. In terms of data collection, the operative time was defined as the time from skin incision to closure. In addition, radiation exposure time, blood loss, intraoperative nerve injury, and surgical complications, such as infection and nonunion, were recorded. A final evaluation of the recovery was made after 12 months. All statistical analyses were performed using PASW Statistics version 18.0 (IBM Co, Armonk, NY). Statistical significance was set at P , 0.05. The patient demographics and fracture characteristics of the 2 treatment groups were compared using a Fisher exact test for nonparametric categorical variables and a Student t test for parametric variables.

RESULTS

union time was an average of 15.8 weeks and 14.6 weeks in the COP and MIPO groups, respectively, excluding cases of delayed union; this difference was not statistically significant (P = 0.588). One delayed union occurred in the COP group. The patient refused further treatment, and the fracture united on follow-up radiographs at 22 months. In all 68 patients, the fractures healed with less than 10 degrees of angular deformity or with less than 1 cm of shortening. From the anteroposterior view, the varus–valgus angular deformities were an average 0.6 degrees in the COP group (range, 5 degrees of valgus to 2 degrees of varus) and 1.5 degrees in the MIPO group (range, 5 degrees of valgus to 9 degrees of varus) (P = 0.276). On lateral radiographs, the average angular deformities were 0.9 degrees (range, 7 degrees of flexion to 7 degrees of extension) in the COP group and 0.8 degrees (range, 8 degrees of flexion to 6 degrees of extension) in the MIPO group (P = 0.494). Radial nerve palsies were preoperatively present in 3 patients (incomplete palsies; none associated with open fractures) in the COP group and in 4 patients (2 complete and 2 incomplete palsies; 1 associated with open fractures) in the MIPO group. Complete recovery of radial nerve function occurred in 2 patients (67%) within 6 months, and the other patient had incomplete recovery with slight limitation at 1 year postoperatively in the COP group. In the MIPO group, the radial nerve palsy of all patients recovered completely within 6 months. Postoperative radial nerve palsy developed in 1 patient (3%) in the COP group but not in the MIPO group. The nerve deficit in 1 patient resolved completely within 3 months. No wound infections occurred in either group. The mean operation time was 116 and 105 minutes in the COP and MIPO groups, respectively (P = 0.106). In the MIPO group, the mean intraoperative radiation exposure time was 68 seconds. In the COP group, fluoroscopy was not used. The operative and intraoperative results are summarized in Table 2. In terms of functional outcomes at an average follow-up of 6 months, the average active shoulder ROM was forward elevation of 174.8 degrees (range, 160–180 degrees), external rotation of 66.1 degrees (range, 50–80 degrees), and internal rotation (at 90 degrees of abduction) of 73.6 degrees (range, 65–80 degrees). The arc of flexion of elbow averaged 137.5 degrees (130–145 degrees) at the last follow-up in the COP group. In the MIPO group, the mean active shoulder ROM was forward elevation of 170.6 degrees (range, 160–180 degrees), external rotation of 69.8 degrees (range, 55–80 degrees), and internal rotation of 70.5 degrees (range, 60–80 degrees). The mean arc of flexion of elbow was 141.0 degrees (130–145 degrees). There was no difference between the 2 groups. The mean UCLA scores were 33.9 in the COP group and 33.1 in the MIPO group (P = 0.264). The mean Mayo elbow performance indices were 95.9 and 96.4, respectively (P = 0.798).

DISCUSSION

Thirty-one fractures (97%) and 38 fractures (100%) were radiographically united by 20 weeks in the COP and MIPO groups, respectively (P = 0.471; Fisher exact test). The

Most isolated humeral shaft fractures are treated successfully with the functional brace.1–3 When surgery is

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Open plating vs MIPO for simple humeral shaft fractures

TABLE 2. The Results of Patients With Humeral Shaft Fractures Operative demographics Operation time (min) Radiation exposure (s) Union time (wk) Functional outcomes UCLA shoulder score (35) Mayo elbow performance index (100) Radiologic outcomes Angulation on sagittal plane (degrees) Angulation on frontal plane (degrees) Complications Malunion Nonunion Delayed union Postoperative radial nerve injury Infection

COP

MIPO

Statistics

116 0 15.8

105 68 14.6

0.106 ,0.001 0.588

33.9 98.9

33.1 96.4

0.264 0.798

0.6

1.5

0.276

0.9

0.8

0.494

0 0 1 1 0

0 0 0 0 0

0.471 0.471

indicated in the cases of certain fractures, MIPO has been reported as a safe and effective method for humeral shaft fractures.13,16,17 However, MIPO is usually known to have biomechanical advantage for comminuted fractures,23–25 with simple fractures traditionally treated with ORIF. We compared the results of MIPO with those of the traditional method. In the present study, surgery was performed primarily on simple fractures in patients with multiple trauma; however, other relative indications for surgery were transverse fractures and patients desiring surgical treatment. As indicated by our results, in both groups, fracture healing occurred in a high percentage of the patients, and the functional outcomes were also excellent based on the Mayo and UCLA scoring system. Therefore, we believe that MIPO is a safe and effective method for simple humeral shaft fractures. The nonunion rate of open plating has been reported to be 4.3%–12.5%.18,26,27 The present study observed no case of noununion and only 1 delayed union for a rate of 3.1% in open plating, and no instance of nonunion in MIPO, although the number of patients included in this study was small. Even in simple fractures, MIPO showed an excellent union rate, which may have potentially resulted from the biologic superiority with less stripping and the preservation of vascularity. These results are consistent with other studies that have reported a nonunion rate of 0%–8.6% for MIPO.12–15 In addition, no postoperative radial nerve injury was observed in the MIPO group, in contrast to the 1 case (3.1%) in the COP group. Although iatrogenic radial nerve injury has been reported to be from 5.1% to 17.6% in open plating,26,28 it can also occur in cases of MIPO. Apivatthakakul et al29 reported that the danger zone for the radial nerve is approximately 3/8 to 5/8 of the humeral length measured from the tip of the acromion process to the lateral epicondyle. The function of the elbow and shoulder was excellent based on the Mayo and UCLA scoring system in both Copyright Ó 2014 Wolters Kluwer Health, Inc. All rights reserved.

groups, which is consistent with previous reports.16,26,30,31 Kobayashi et al16 reported that an early full range of shoulder and elbow motion was possible in patients who underwent MIPO, and that the median time to normal motion recovery in these patients was 19 days in the shoulder and 60 days in the elbow. In closed and minimally invasive techniques with indirect fracture reduction, malalignment is a more common complication as compared with conventional open reduction.32,33 In particular, intraoperative limb length, axial alignment, and rotation must be carefully assessed to prevent malalignment.34 Malalignment was not observed in the MIPO group in the present study; however, the mean intraoperative radiation exposure time was 68 seconds. Zhiquan et al15 reported it was necessary to confirm the reduction states with an image intensifier repeatedly for successful results using closed reduction in MIPO. As indicated by our results, the repeated use of fluoroscopy could avoid malalignment, but this might increase the radiation hazard. Surgeons should be cautious about their exposure to radiation during fracture management. However, radiation exposure can be minimized with proper personal radiation protection, including the routine use of a thyroid shield and a radio-protective apron.35 This study has several limitations. First, the number of patients was relatively small, and greater patient numbers could provide more information for validating this technique. A large number of patients were expected to compare differences in function and fracture healing. However, it is not easy to enroll hundreds of patients in clinical practice. Therefore, we designed the power analysis to determine a difference in complication rates and our healing rates. Thus our healing rates and functional assessments may include type II error. Second, because this study was performed at 5 centers, there might be a bias associated with a multicenter study including measuring ROM and obtaining x-rays. Although all surgeons were experienced, a potential for bias was present because the surgeries were performed at the different centers. However, because we performed a standard surgical procedure based on basic fracture principles, the potential for bias is expected to be minimized. Another bias may arise in patient selection.

CONCLUSIONS This study demonstrated that simple humeral shaft fractures had a high rate of union with either a COP or MIPO fixation technique and that the functional outcomes were also excellent based on the Mayo and UCLA scoring system, regardless of fixation method. Therefore, we believe that MIPO is equivalent to COP as a safe and effective method for simple types of humeral shaft fractures when surgery is indicated, and performed by surgeons experienced in MIPO techniques. REFERENCES 1. Ekholm R, Tidermark J, Tornkvist H, et al. Outcome after closed functional treatment of humeral shaft fractures. J Orthop Trauma. 2006;20: 591–596.

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Treatment of Humeral Shaft Fractures: Minimally Invasive Plate Osteosynthesis Versus Open Reduction and Internal Fixation.

Comparison of minimally invasive plate osteosynthesis and conventional plate osteosynthesis for humeral shaft fracture: A meta-analysis.

Minimally invasive plate osteosynthesis vs conventional fixation techniques for surgically treated humeral shaft fractures: a meta-analysis.

Management of Humeral Shaft Fractures; Non-Operative Versus Operative.

Minimal invasive percutaneous plate osteosynthesis (MIPPO) through deltoid-pectoralis approach for the treatment of elderly proximal humeral fractures.

Treatment of Middle Third Humeral Shaft Fractures with Anteromedial Plate Osteosynthesis through an Anterolateral Approach.

Humeral shaft fracture management, a prospective study; nailing or plating.

Minimal invasive ostheosintesis for treatment of diaphiseal transverse humeral shaft fractures.

Shoulder function after surgical treatment of displaced fractures of the humeral shaft: a randomized trial comparing antegrade intramedullary nailing with minimally invasive plate osteosynthesis.

Secondary Radial Nerve Palsy after Minimally Invasive Plate Osteosynthesis of a Distal Humeral Shaft Fracture.

Minimally Invasive Plate Osteosynthesis in Open Pediatric Tibial Fractures.

Position of polyaxial versus monoaxial screws in locked plating for proximal humeral fractures: analysis of a prospective randomized study.

Minimally invasive plate osteosynthesis using 3D printing for shaft fractures of clavicles: technical note.

Minimal Invasive Percutaneous Osteosynthesis for Elderly Valgus Impacted Proximal Humeral Fractures with the PHILOS.

Biomechanical Study of the Fixation Strength of Anteromedial Plating for Humeral Shaft Fractures.

Outcome Assessment of Operative Treatment of Humeral Shaft Fractures by Antegrade Unreamed Humeral Nailing (UHN).

Dynamic compression plating versus locked intramedullary nailing for humeral shaft fractures: a meta-analysis of RCTs and nonrandomized studies.

Nonoperative treatment of humeral shaft fractures revisited.

Minimally invasive plate osteosynthesis for distal tibial fractures.

Minimally invasive plate osteosynthesis for distal radius fractures.

Operative versus nonoperative treatment in complex proximal humeral fractures.

Outcome of locking compression plating for proximal humeral fractures: a prospective study.

Mid-term results of a less-invasive locking plate fixation method for proximal humeral fractures: a prospective observational study.

Displaced proximal humeral fractures: operative versus non-operative treatment--a 2-year extension of a randomized controlled trial.