[Intervention Protocol] Surgical interventions for treating distal humeral fractures in adults Yan Wang 1, Peifu Tang 1, Wei Yang 2, Qi Zhuo 1 1 Depar

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1 T A B L E O F C O N T E N T S HEADER ABSTRACT BACKGROUND OBJECTIVES METHODS ACKNOWLEDGEMENTS REFERENCES APPENDICES HISTORY CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST SOURCES OF SUPPORT i

2 [Intervention Protocol] Surgical interventions for treating distal humeral fractures in adults Yan Wang 1, Peifu Tang 1, Wei Yang 2, Qi Zhuo 1 1 Department of Orthopaedic Surgery, Chinese PLA General Hospital, Beijing, China. 2 Department of Endocrinology, Chinese PLA General Hospital, Beijing, China Contact address: Qi Zhuo, Department of Orthopaedic Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Beijing, Beijing, , China. qizhuo301@gmail.com. Editorial group: Cochrane Bone, Joint and Muscle Trauma Group. Publication status and date: New, published in Issue 6, Citation: Wang Y, Tang P, Yang W, Zhuo Q. Surgical interventions for treating distal humeral fractures in adults. Cochrane Database of Systematic Reviews 2012, Issue 6. Art. No.: CD DOI: / CD A B S T R A C T This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effects (benefits and harms) of surgical interventions for distal humeral fractures. The main comparisons will be between: 1. surgical and conservative treatment 2. different methods of surgical treatment 1

3 B A C K G R O U N D Description of the condition The distal humerus is the end of the upper arm bone (the humerus) that forms the upper part of the elbow joint (AAOS 2011). Approximately 7% of all adult fractures are elbow fractures, with fractures of the distal humerus accounting for 30% of these (Anglen 2005). An annual incidence of 5.7 distal humeral fractures per 100,000 people was reported for Edinburgh over the period 1988 to 1997 (Robinson 2003). Although this may seem low, the number of cases is growing rapidly as the population ages. In their study of low-trauma distal humeral fractures among women 60 years of age or older, Palvanen 2010 reported a greater than fivefold increase in the annual total number of these fractures (there were 42 fractures in 1970 and 224 in 1998) and a dramatic increase in the age-adjusted incidence over the same period (1970 to 1998) from 12 to 34 per 100,000 people per year. There is a well-documented bimodal distribution of these fractures, with an early peak in young people, mainly males, aged between 12 and 19 years, from high-energy trauma, and a second peak in older women, aged 60 years and over, who typically have osteoporosis and whose fracture results from a low-energy fall (Robinson 2003). The anatomy of the distal humerus is highly complex, reflecting its articulation with both forearm bones (the radius and ulna). It allows for wide range of motion in multiple planes (the ulnohumeral joint for flexion (bending) and extension (straightening out) of the elbow, and the radiocapitellar joint for forearm rotation). Elbow motion is generally difficult or impossible when the distal humerus is fractured. In addition, the structure of the elbow leaves the ulnar and radial nerves vulnerable to injury: for example, around a quarter of patients with type C fractures (see below) were found to have ulnar nerve palsy before undergoing surgery in two studies (Bucholz 2006; Ruan 2009). There are several classification systems for distal humeral fractures. The traditional descriptive classification was based on the concept of the distal humerus comprising two triangular columns of bone (lateral (outer) side of the distal humerus aligned with the radius and medial (inner) side of the distal humerus aligned with the ulna) and the relationship of fracture location to the olecranon fossa (a deep triangular depression on the posterior (back) side of the humerus). The fractures can thus be broadly classified into supracondylar (above the olecranon fossa), single column (condyle) fractures and bi-column fractures (these are the most common). Jupiter and Mehne (Jupiter 1992) advocated a classification scheme based on intraoperative observations of fracture patterns, and described as high T, low T, Y, H, medial lambda and lateral lambda patterns. A more comprehensive and the most commonly used system is the Orthopaedic Trauma Association/Arbeitsgemeinschaft für Osteosynthesefragen (OTA/AO) classification system. In this system, similar to that for other periarticular fractures, type A describes an extra-articular fracture, type B fractures extend into the articular surface but are partial articular often involving one column, and C is a complete intra-articular fracture in which articular surface is separated from the shaft of the humerus. With the further use of numerical attachments from 1 to 3, the fracture of distal humerus are subdivided into subtypes based on the extent of comminution and specific fracture pattern (Rüedi 2007). Description of the intervention Surgical management is widely considered to be indicated for displaced fractures of the distal humerus (Riseborough 1969). Surgical interventions for distal humeral fractures include: 1) open reduction (to reposition the bone fragments) and internal fixation (to hold the bone fragments in place until the bone is healed) with various devices such plates and screws; 2) total elbow replacement/ arthroplasty (TEA) where the distal humerus and ulna bone ends forming the elbow are replaced by an artificial joint; 3) closed reduction and external fixation (the device holding the pins placed in the bones is external to the skin); and 4) elbow hemiarthroplasty (currently this uncommon intervention where only the distal humerus is replaced is not approved in many countries). Numerous surgical approaches have been described, almost all of which employ a universal posterior midline skin incision (Wong 2008). The ulnar nerve is almost always identified and protected at the elbow, though whether the ulnar nerve is left in situ or transposed is left to the preference of the surgeon (Nauth 2011). It is notable that for open reduction and internal fixation (ORIF) there has been a variety of implant types, including precontoured metal plates and locking plates, and fixation techniques that have been described and recently developed. Non-operative treatment is generally viewed to have a limited role to play in treating distal humeral fractures (Baratz 2006). It is generally reserved for completely undisplaced fractures, and for patients who cannot tolerate anaesthesia or who have medical comorbidities that render them unsuitable for surgery, such as advanced dementia, and those with limited arm function such as stroke-related paralysis. Non-operative (conservative) treatment typically involves the so-called bag of bones treatment that consists of immobilisation of the elbow in 60 of flexion for two to three weeks, followed by gentle motion exercises (Baratz 2006). Pehlivan 2002 reported good outcomes from functional bracing of extra-articular supracondylar distal one-third humeral shaft fractures. How the intervention might work Surgical intervention is widely considered to have superior clinical outcomes for displaced distal humeral fractures. Currently, there are a variety of internal fixation techniques The goal of ORIF of a fracture of distal humerus is to accomplish: 1) anatomic reduction and reconstruction of the elbow joint and the articular surface, 2

4 2) rigid stabilisation and fixation of the articular surface to the humeral shaft (diaphysis), and 3) early motion exercises to minimize joint stiffness. However, this goal becomes difficult to achieve in a group of patients who are greater than 65 years, have sustained a highly comminuted type C fracture, and have low bone quality due to osteoporosis. In such patients, total elbow arthroplasty is often considered to be a better choice compared with ORIF (Thomas 2011). Since the introduction of bi-columnar plating for the fixation of fractures of distal humerus by the AO, a number of implants and fixation methods are available for ORIF. Typically, the decisions regarding the choice of both the implants and fixation techniques will be dictated by the fracture pattern and degree of comminution. Precontoured periarticular distal humerus locking plates are currently the most popular choice of treatment for distal humeral fractures, though their use is still controversial (Galano 2010). Regarding dual plate fixation, there is considerable amount of debate pertaining to its position or orientation as orthogonal plates (90-90 on separate columns), or parallel plates (medial and lateral supracondylar ridges). Other currently less popular modalities for fixation include simple Kirschner wires or screws, 3.5-mm pelvic reconstruction plates, and limited-contact dynamic compression plates. Total elbow arthroplasty (TEA) has emerged as a viable option for some patients (Thomas 2011). Common indications include patients with a severe articular comminution of the distal humerus; and those with pre-existing inflammatory or degenerative symptomatic elbow arthritis. Irrespective of age, functional low-demand and compliancy is necessary for successful total elbow arthoplasty. The main disadvantages of TEA include a lifting restriction of 5 pounds or 2.3 kg for repetitive lifting and 10 pounds or 4.5 kg for a single lift with the affected arm, the risk of implant loosening, periprosthetic fractures, infection and prosthetic failure. Although elbow hemiarthroplasty could be a better option in appropriately selected patients, it is not approved in most countries. Non-operative treatment involves immobilisation of the injured elbow followed by physiotherapy and motion exercises. Immobilisation (e.g. in a long-arm cast) is helpful in terms of maintaining fracture stabilisation and providing pain relief and reducing swelling during the healing process. However, a major disadvantage is the high risk of the elbow becoming stiff, with a diminished range of motion subsequently. For displaced distal humeral fractures, closed reduction with immobilisation is difficult to achieve and maintain, and joint articular incongruity can result. Rehabilitation generally comprises motion exercises and physiotherapy. Although fractures of the distal humerus account for only around two per cent of all adult fractures, they are increasingly common and can be a debilitating injury leading to long-term impairment and disability, including that from post-traumatic elbow arthritis. They are also difficult to treat because of the complexity of bony anatomy of the distal humerus and increasing number of osteoporotic fractures. Most distal humeral fractures need surgical intervention with open reduction and internal fixation (ORIF) being the standard surgical treatment, especially in younger patients. Moreover, a variety of new techniques for exposure and precontoured locking plates are considered to give a better outcome. However, there are scenarios where osteoporosis in older patients renders ORIF impossible. While total elbow arthroplasty and distal humeral hemiarthroplasty may be viable options, they are not without their own limitations and complications. Given the challenges and controversies regarding treating these fractures, there is a need to systematically review the current evidence of the effectiveness of surgical interventions for treating distal humeral fractures in adults. O B J E C T I V E S To assess the effects (benefits and harms) of surgical interventions for distal humeral fractures. The main comparisons will be between: 1. surgical and conservative treatment 2. different methods of surgical treatment M E T H O D S Criteria for considering studies for this review Types of studies Randomised controlled trials (RCTs) and quasi-randomised controlled trials (method of allocating participants to a treatment which is not strictly random: e.g. by date of birth, hospital record number, alternation) evaluating surgical interventions for treating distal humeral fractures. Why it is important to do this review Types of participants Skeletally mature people of either gender with a fracture of the distal humerus. Trials containing participants with other elbow injuries will be included provided the primary focus is on the treatment of the distal humeral fracture. Studies testing secondary surgery after failed non-surgical treatment will be excluded. 3

5 Types of interventions All types of surgical interventions including open reduction and internal fixation (ORIF: e.g. locking plates, reconstruction plate, lag screws and K-wires) and joint arthroplasty/hemiarthroplasty will be included. The two main comparisons will be: Any surgery compared with conservative treatment (e.g. arm sling, splint, closed reduction/traction if displaced and cast immobilisation) ORIF as a whole compared with joint arthroplasty Different types of surgical interventions (e.g. different types of plating) will also be included. Studies testing secondary surgery after failed non-surgical treatment will be excluded. Search methods for identification of studies Electronic searches We will search the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to present), the Cochrane Central Register of Controlled Trials (The Cochrane Library, current issue), MEDLINE (1946 to present), and EMBASE (1980 to present). No language or publication restrictions will be applied. In MEDLINE (Ovid Online), the subject-specific strategy will be combined with the sensitivity-maximising version of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (Lefebvre 2011). In order to identify recently completed, unpublished and ongoing trials, we will search Current Controlled Trials and the WHO International Clinical Trials Registry Platform. Types of outcome measures Primary outcomes 1. Functional outcomes: patient-reported measures of joint functions (e.g. the Mayo Elbow Performance Score (MEPS), the Disability of the Arm, Shoulder, Hand (DASH) score and other validated clinical rating scales) 2. Treatment failure (e.g. further or secondary surgery indicated) Primary outcomes will be analysed separately. Secondary outcomes 1. Pain (long-term) 2. Adverse events (e.g. malunion/nonunion, ulnar neuropathy, post-traumatic arthritis, heterotopic ossification, infection) 3. Elbow range of motion (elbow extension/flexion, forearm supination/pronation) 4. Anatomical outcomes (e.g. distal humeral tilt in radiographic observations) Where possible, adverse events will be pooled, and the remaining secondary outcomes analysed separately. Timing of outcome assessment If data are available, we will present outcome data for the following time periods: short term follow-up (up to six months following treatment); intermediate follow-up (more than six months and up to 12 months after the end of treatment) and long-term (greater than 12 months after the end of treatment). Longer term outcome data (two years and above) will be extracted and assessed if available. Different time periods will be analysed separately. Searching other resources We will check the reference lists of published studies to identify additional trials. Where necessary, authors of identified studies and companies who produce relevant products will be contacted. Data collection and analysis Selection of studies Both review authors (ZQ, YW) will assess the results of the searches. To determine which studies are to be assessed further, the authors will independently scan the titles, abstracts and keywords of every record retrieved. Full articles will be retrieved for further assessment. Where necessary, we will contact the original authors of identified studies for missing information. Differences in opinion will be resolved by discussion, or a third party will be consulted. Data extraction and management Each trial will be assessed independently by two authors (ZQ, YW). Information on trial design, study population, interventions and outcomes will be extracted independently by two authors (ZQ, YW) using a data extraction form specifically designed for this review. Differences will be resolved by referring back to the original article and reaching a consensus. When necessary, information will be sought from the trial authors. Assessment of risk of bias in included studies Risk of bias will be assessed independently by two authors (ZQ, YW) using the criteria described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). The following sources of bias will be assessed: 4

6 1. Randomisation process: assessment for selection bias 2. Allocation concealment process: assessment of selection bias 3. Blinding of participants and care personnel: assessment for performance bias 4. Blinding of outcome assessors: and detection bias 5. Incomplete data bias 6. Selective reporting bias 7. Other potential source of bias such as major imbalances in key baseline characteristics Where necessary, disagreements will be resolved by discussion. Measures of treatment effect We expect to find both event (dichotomous) data (e.g. adverse events as in secondary outcomes) and continuous data (e.g. primary outcomes). Risk ratios (RR) with 95% confidence intervals (CI) will be used for reporting dichotomous data. We intend to calculate the risk difference (RD) and convert the RD into the number needed to treat for an additional beneficial outcome (NNTB) or the number needed to treat for an additional harmful outcome (NNTH) if the RR is statistically significant. Continuous data will be expressed as difference in means (MD) with 95% confidence intervals (CI). We will use standardised mean difference (SMD) when outcomes are reported using different scales or scoring system. Unit of analysis issues We expect the unit of analysis in this review to be individual patients, but will be alert to other potential unit of analyses issues, such as the inclusion of patients undergoing more than one intervention, repeated observation from more than one time-point, and multiple observations for the same outcome (e.g. total adverse events). Should any such issues arise, we will seek advice from methodological experts. Dealing with missing data When necessary, missing data, particularly denominators and standard deviations, will be sought from the authors of the primary studies. Intention-to-treat analyses will be performed wherever possible. Missing standard deviations will not be imputed unless these can be inferred. Assessment of heterogeneity Besides the visual inspection of forest plot analyses, heterogeneity will be examined using the Chi² statistic with significance set at P < 0.1. The I² statistic (Higgins 2003) will be used to estimate total variation across studies that is due to heterogeneity rather than chance or sampling error where 0% to 40% might not be important, 30% to 60% may represent moderate levels, 50% to 75% may represent substantial heterogeneity and 75% to 100% considerable heterogeneity (Higgins 2011). Possible sources of heterogeneity will be assessed by sensitivity and subgroup analysis. Assessment of reporting biases Provided data can be pooled from 10 or more trials, we examine potential publication biases by producing funnel plots (Egger 1997). Data synthesis Based on statistical and clinical heterogeneity between included studies, we will decide whether to pool data in a meta-analysis. Fixed-effect models will be used unless there is significant or unexplained heterogeneity, in which case a random-effects model will be used. Subgroup analysis and investigation of heterogeneity Possible sources of heterogeneity will be assessed using subgroup analysis as follows, which may be conducted based on: 1. Fracture types (the AO classification system categories: A, B and C) 2. Age (under versus over 65 years old) 3. Different interventions (main categories) 4. Open versus closed fractures Sensitivity analysis We plan to perform sensitivity analyses in order to explore the influence of the following factors on effect size, by repeating the analysis and: 1. excluding unpublished studies; 2. excluding studies at unclear or high risk of bias relating to non concealment of allocation, non blinding of outcome assessors, incomplete outcome data; 3. using different measures of calculating treatment effects (e.g. risk difference, odds ratio) and different statistical models (fixed-effect and random-effects models). A C K N O W L E D G E M E N T S Our gratitude goes to Helen Handoll, David Ring and Cathie Sherrington for valuable comments about this protocol. We also acknowledge the help of Catherine Deering for her assistance with the development of the search strategies and Lindsey Elstub for helpful comments. 5

7 R E F E R E N C E S Additional references AAOS 2011 American Academy of Orthopaedic Surgeons. Distal Humerus Fractures. Available at topic.cfm?topic=a00513 (accessed 12/09/2011). Anglen 2005 Angelen J. Distal humerus fractures. Journal of the American Academy of Orthopaedic Surgeons 2005;13: Baratz 2006 Baratz ME, Seth AK. Fractures of the elbow. Trumble, Thomas E, editors(s). Hand, Elbow & Shoulder: core knowledge in orthopaedics. Philadelphia: Mosby Elsevier, 2006: Bucholz 2006 Bucholz RW, Heckman JD, Court-Brown C. Rockwood and Green s Fractures in Adults. Rockwood and Green s Fractures in Adults. Vol. 2, Lippincott Williams & Wilkins, 2006:2400. Egger 1997 Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315: Galano 2010 Galano GJ, Ahmad CS, Levin WN. Current treatment strategies for bi-columnar distal humerus fractures. Journal of the American Academy of Orthopaedic Surgeons 2010;18: Higgins 2003 Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327: Higgins 2011 Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version [updated March 2011]. The Cochrane Collaboration, Available from Jupiter 1992 Jupiter JB, Mehne DK. Fractures of the distal humerus. Orthopedics 1992;15: Lefebvre 2011 Lefebvre C, Manheimer E, Glanville J. Chapter : Searching for studies. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version [updated March 2011]. The Cochrane Collaboration, Available from Nauth 2011 Nauth A, McKee MD, Ristevski B, Hall J, Schemitsch EH. Distal Humeral Fractures in Adults. Journal of Bone and Joint Surgery - American Volume 2011;93: Palvanen 2010 Palvanen M, Kannus P, Niemi S, Parkkari J. Secular trends in distal humeral fractures of elderly women: nationwide statistics in Finland between 1970 and Bone 2010; 46: Pehlivan 2002 Pehlivan O. Functional treatment of the distal third humeral shaft fractures. Archives of Orthopaedic and Trauma Surgery 2002;122: Riseborough 1969 Riseborough EJ, Radin EL. Intercondylar fractures of the humerus in the adult: A comparison of operative and nonoperative treatment in twenty-nine cases. Journal of Bone and Joint Surgery - American Volume 1969;51: Robinson 2003 Robinson CM, Hill RMF, Jacobs N, Dall G, Court- Brown CM. Adult distal humerus metaphyseal fractures: epidemiology and results of treatment. Journal of Orthopaedic Trauma 2003;17: Ruan 2009 Ruan HJ, Liu JJ, Fan CY, Jiang J, Zeng BF. Incidence, management and prognosis of early ulnar nerve dysfunction in type C fractures of distal humerus. Journal of Trauma 2009;67: Rüedi 2007 Rüedi TP, Buckley RE, Moran CG. AO Principles of Fracture Management, ed 2. Thieme, Thomas 2011 Thomas LM, James BB. Distal humeral fractures: fixation versus arthroplasty. Journal of Shoulder and Elbow Surgery 2011;20:S Wong 2008 Wong AS, Baratz MD. Elbow fractures: distal humerus. Current concepts. Journal of Hand Therapy 2008;34: Indicates the major publication for the study 6

8 A P P E N D I C E S Appendix 1. Search strategies The Cochrane Central Register of Controlled Trials (Wiley Online Library) #1 MeSH descriptor Humerus, this term only #2 MeSH descriptor Elbow, this term only #3 (#1 OR #2) #4 MeSH descriptor Fractures, Bone, this term only #5 MeSH descriptor Fracture Fixation explode all trees #6 MeSH descriptor Fracture Healing, this term only #7 (#4 OR #5 OR #6) #8 (#3 AND #7) #9 MeSH descriptor Humeral Fractures, this term only with qualifier: SU #10 (humer* or elbow*) NEAR/3 (fractur* or fixat*):ti,ab,kw #11 (#8 OR #9 OR #10) #12 (distal* or elbow* or condyl* or supracondyl* or epicondyl* or transcondyl* or intercondyl* or bicondyl* or transchondral*): ti,ab,kw #13 (#11 AND #12) MEDLINE (Ovid Online) 1 Humerus/ or Elbow/ 2 Fractures, Bone/ 3 exp Fracture Fixation/ 4 Fracture Healing/ 5 2 or 3 or and 5 7 exp Humeral Fractures/su [Surgery] 8 ((humer$ or elbow$) adj3 (fractur$ or fixat$)).tw. 9 6 or 7 or 8 10 (distal$ or elbow$ or condyl$ or supracondyl$ or epicondyl$ or transcondyl$ or intercondyl$ or bicondyl$ or transchondral$).tw and Randomized controlled trial.pt. 13 Controlled clinical trial.pt. 14 randomized.ab. 15 placebo.ab. 16 Drug therapy.fs. 17 randomly.ab. 18 trial.ab. 19 groups.ab. 20 or/ exp Animals/ not Humans/ not and 22 EMBASE (Ovid Online) 1 Humerus/ or Elbow/ 2 Fracture/ 7

9 3 Fracture Healing/ 4 exp Fracture Treatment/ 5 2 or 3 or and 5 7 Humerus Fracture/ or Humerus Supracondylar Fracture/ 8 ((humer$ or elbow$) adj3 (fractur$ or fixat$)).tw. 9 6 or 7 or 8 10 (distal$ or elbow$ or condyl$ or supracondyl$ or epicondyl$ or transcondyl$ or intercondyl$ or bicondyl$ or transchondral$).tw and Randomized controlled trial/ 13 Clinical trial/ 14 Controlled clinical trial/ 15 Randomization/ 16 Single blind procedure/ 17 Double blind procedure/ 18 Crossover procedure/ 19 Placebo/ 20 Prospective study/ 21 ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw. 22 (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw. 23 ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw. 24 (cross?over$ or (cross adj1 over$)).tw. 25 ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw. 26 RCT.tw. 27 or/ Case Study/ or Abstract Report/ or Letter/ not and 29 H I S T O R Y Protocol first published: Issue 6, 2012 C O N T R I B U T I O N S O F A U T H O R S ZQ, YW, Peifu Tang, and Yan Wang all contributed to the preparation of the protocol. ZQ will be the guarantor of the review. D E C L A R A T I O N S O F None known. I N T E R E S T 8

10 S O U R C E S O F S U P P O R T Internal sources Chinese PLA General Hospital, China. External sources No sources of support supplied 9