Interventions for treating proximal humeral fractures in adults (Review)

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0.06 to 0.97). However, Rommens 1993 reported that they had found no differences in the end result, either in terms of fracture healing or functional outcome. (b) Continuing management (rehabilitation) after initial conservative treatment involving sling immobilisation Two trials compared conventional physiotherapy during the 12 weeks following trauma with self-treatment following a course of instruction (Bertoft 1984; Lundberg 1979). Unfortunately, data from these two small trials could not be pooled because of incompatible outcome measures. In both trials there were no statistically significant differences between those receiving instruction for exercises at home and those undergoing supervised physiotherapy in any of the outcomes recorded (see Analyses 04.01 to 04.06). Revay 1992 reported that the addition of supervised exercises in a swimming pool to self-treatment did not enhance long term outcome. Participants of the control group (self-treatment only) were reported as having significantly better functional movements, joint mobility and activities of daily living at two and three month follow up. However, there were no significant differences at one year. Revay 1992 suggested that those using the pool may have neglected their home exercises, but the authors did not evaluate compliance. Livesley 1992 reported that there was no difference in outcome between the two groups (receiving pulsed electromagnetic high frequency energy (PHFE) versus placebo) at any stage of the trial, but provided no quantitative data. All trial participants were reported as achieving a “good” result as converse to a “poor” one. (2) Surgical treatment versus conservative treatment Three trials evaluated surgical interventions for displaced or highgrade fracture configurations, or both. Kristiansen 1988 studied 30 people with 31 displaced two, three or four-part fractures, and assessed the quality of fracture reduction, healing and function. Fractures were reduced under general anaesthetic either by attempting to skewer the fracture fragments using a Steinmann pin inserted transcutaneously, or by simple closed manipulation alone. Treatment failure, defined as a change of method resulting from a poor initial fracture reduction or removal of pins due to infection, occurred in three cases (see Analysis 05.01). Overall, the quality of fracture reduction was probably better in the surgical group. However, since the reduction was held in these patients by application of an external fixator (the Steinmann pin was removed) and in the other group by use of a simple sling, the long-term results reflect the overall effect of initial treatment and method of immobilisation. Of those followed up to one year, fewer participants of the surgical group had a poor or unsatisfactory rating of function (see Analysis 05.02: 3/11 versus 6/10; RR 0.45, 95% CI 0.15 to 1.35). Data provided for the complications of avascular necrosis, non-union and refracture are presented in Analysis 05.03. None of the differences between the two groups for the outcomes shown in the analyses were statistically significant. Interventions for treating proximal humeral fractures in adults (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Zyto 1997 included only people with displaced three and fourpart fractures in their analyses. Forty patients were allocated either to surgical treatment with cerclage wiring of the displaced fragments, which in some cases was placed around longitudinal wires in tension band fashion, or conservative treatment where the injured arm was supported in a sling. No manipulation of the fracture was attempted in the conservative group. One year later, there were major complications only in the surgical group (see Analysis 06.01). At 50 months, only 29 participants were reviewed. Displacement of the greater tuberosity was found in three people treated conservatively and osteoarthritis in two people in each group (see Analysis 06.01). Similarly, there were no statistically significant differences between the two groups at either one or three years in subjective assessment of function (see Analyses 06.02). Similarly, there was no difference at three years in the Constant score (Constant 1987) in terms of the overall functional score (see Analysis 06.03: MD -5.00, 95% CI -17.52 to 7.52). Though statistically significant, the clinical relevance of the three point difference in the range of motion component of the Constant score is questionable (see Analyses 06.03 for the main components of the Constant score: pain, range of motion, power and activities of daily living). Stableforth 1984 included 32 people with displaced four-part fractures in their comparison of an uncemented Neer prosthesis versus closed manipulation. The forearm and elbow were supported in a sling in both groups, and supervised physiotherapy was provided to all participants between three and six months. Two surgical group participants developed haematomas; one resolved but the other became infected and the prothesis was subsequently removed. One person in each group died before six months from “causes unrelated” to their fracture. By six months, significantly fewer participants of the prosthesis group needed some help with activities of daily living or had died (see Analysis 07.03: 2/16 versus 9/16; RR 0.22, 95% CI 0.06 to 0.87). Nearly all trial participants had shoulder pain but significantly fewer in the prosthesis group reported pain that impaired sleep or function (see Analysis 07.04: 2/13 versus 9/12; RR 0.21, 95%CI 0.06 to 0.76). This result is no longer statistically significant in a worst case analysis where the missing participants of the prosthesis group are assumed to be in constant pain, whereas those missing from the conservative group are not (4/15 versus 9/15; RR 0.44, 95% CI 0.17 to 1.13; NS). Reduced muscle strength and restricted mobility were less frequent in the prosthesis group survivors (see Analyses 07.05 and 07.06). (3) Different methods of surgical management The one trial in this category (Hoellen 1997) compared humeral head replacement with an endoprosthesis (internally placed implant) against reduction and stabilisation of the fracture using tension band wiring. All 30 patients reported in Hoellen 1997 had four-part fractures, as per the reported study inclusion criteria. Patients with three-part fractures were also eligible according to 11
a later report of the trial which involved an extension of the recruitment period (Holbein 1999). Holbein 1999 reported on 39 patients, one with bilateral fractures, and gave results for one and two year follow up for 31 and 24 patients respectively. However, until we obtain further information from the trialists, we will continue to report the results from Hoellen 1997. In Hoellen 1997, results for only 18 of the 30 trial participants were available at one year. There were no serious peri-operative or post-operative complications such as pulmonary embolism. No participants of the replacement group required further surgery compared with five participants of the osteosynthesis group (the wires displaced in four participants and the fracture fell apart in one participant): RR 0.09, 95% CI 0.01 to 1.51 (see Analyses 08.01 and 08.02). The mean Constant scores (minus the power component) for the 18 people available at one year follow up were similar in the two groups (48 versus 49 points out of a maximum of 75). Though, we wait on clarification on the results presented in Holbein 1999, these did not differ in a major way from those in Hoellen 1997. Again there were no serious peri- or post operative medical complications in either group. No participant of the replacement group required further surgery compared with nine of the osteosynthesis group. Similar functional results, pain and activities of daily living, were reported in both groups. The greater range of motion and power found for the osteosynthesis group did not appear to affect patient-rated satisfaction with function, which was similar in both groups at both follow-up times. (4) Continuing management (including rehabilitation) after initial surgical treatment Wirbel 1999 tested the duration of immobilisation (one week versus three weeks) before starting physiotherapy after closed reduction and percutaneous fixation of displaced fractures in 77 patients. Most of the results given in the trial report were either for the whole study population or split by basic AO fracture type. Wirbel 1999 reported that there were no statistically significant differences between the two trial groups in their functional results, assessed using the Neer score, at three, six or at an average of 14.2 months. Data provided for unsatisfactory or worse outcome, as defined by the Neer score, at six months are consistent with this claim (see Analysis 09.01: 9/32 versus 10/32; RR 0.90, 95% CI 0.42 to 1.92). Premature removal of Kirschner wires because of loosening occurred in the five people in each group; these results, however, were not provided for the whole study population nor was it indicated to which groups the five people who underwent open revision or hemi-arthroplasty belonged. Though similar numbers (3 versus 2) of people underwent removal of screws due to subacromial impingement after six months, the numbers of people in each group whose displaced tuberosity fractures were fixed with cannulated screws were not reported. Of the 21 participants followed up more than two years, one developed partial necrosis of the humeral head but was symptom-free and had a full range of motion of his affected shoulder. Interventions for treating proximal humeral fractures in adults (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. D I S C U S S I O N There are few randomised trials evaluating treatment options for proximal humeral fracture in adults. Our search was comprehensive and it is likely that we have identified almost all of the published randomised trials relevant to this area. However, our search may have overlooked trials including proximal humeral fractures as a subgroup that were not referred to in the citation or abstract, or sometimes even in the text of a trial report. There are five ongoing trials that should provide important data in the future. Difficulties in patient recruitment appears to be a key problem in this area, particularly in trials involving surgery, as shown by the abandonment of two trials, one involving three centres, listed as ongoing in the first version of this review, as well as the slow and lower-thanplanned recruitment in other trials. Another multi-centre trial was discovered to have been abandoned in this update. Even those questions that have been addressed in the 12 included trials remain substantively unanswered, as generally the trials were small and had methodological shortcomings. Disparate outcome measures meant that pooling of data was not possible in the two trials that evaluated a similar comparison. The high losses to follow up and exclusion of participants from the analyses in some trials are a concern. There is clearly a need for caution in interpreting the results of small trials which demonstrate “no evidence of an effect” rather than “evidence of no effect”. The measurement of outcome was variable, though generally comprehensive, often with the use of non-validated scoring systems such as the Neer (Neer 1970) and Constant (Constant 1987) systems, but also simple rating systems for individual outcomes. Validated assessment schemes such as the Shoulder Rating Questionnaire (L’Insalata 1997) for subjective assessment of symptoms and function were not available at the time for most of the included trials. Nonetheless, some consideration of interobserver reproducibility and other aspects of validity was evident in the establishment of the Constant score and in two trials (Lundberg 1979; Zyto 1997). Non-validated outcome assessment schemes, often with arbitrary criteria for grading overall outcome (excellent, good, fair, poor), are probably best viewed as ’blunt’ and flawed instruments. This needs to be noted when viewing the results of most of the included trials; in particular Kristiansen 1989 whose outcome assessment is almost completely based on the Neer scoring system. Hodgson 2003 is an exception in its use of the SF36 health survey and a validated scheme for self-reported disability resulting from shoulder problems (Croft 1994). The majority of the trials used Neer’s fracture classification (Neer 1970). Problems, such as poor interobserver reproducibility and intraobserver reliability, with the classification of fractures according to the Neer and AO systems have been shown for both radiographs and computerised tomographic scans (Bernstein 1996; Sidor 1993; Siebenrock 1993; Sjoden 1997). This variation in the classification of fractures and hence diagnosis needs to be consid- 12
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I N D E X T E R M S Medical Subject
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