Interventions for treating proximal humeral fractures in adults
Research output: Contribution to journal › Review › Research › peer-review
Documents
- Handoll_et_al-2022-Cochrane_Database_of_Systematic_Reviews
Final published version, 3.53 MB, PDF document
Background: Fractures of the proximal humerus, often termed shoulder fractures, are common injuries, especially in older people. The management of these fractures varies widely, including in the use of surgery. This is an update of a Cochrane Review first published in 2001 and last updated in 2015. Objectives: To assess the effects (benefits and harms) of treatment and rehabilitation interventions for proximal humeral fractures in adults. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trial registries, and bibliographies of trial reports and systematic reviews to September 2020. We updated this search in November 2021, but have not yet incorporated these results. Selection criteria: We included randomised and quasi-randomised controlled trials that compared non-pharmacological interventions for treating acute proximal humeral fractures in adults. Data collection and analysis: Pairs of review authors independently selected studies, assessed risk of bias and extracted data. We pooled data where appropriate and used GRADE for assessing the certainty of evidence for each outcome. We prepared a brief economic commentary for one comparison. Main results: We included 47 trials (3179 participants, mostly women and mainly aged 60 years or over) that tested one of 26 comparisons. Six comparisons were tested by 2 to 10 trials, the others by small single-centre trials only. Twelve studies evaluated non-surgical treatments, 10 compared surgical with non-surgical treatments, 23 compared two methods of surgery, and two tested timing of mobilisation after surgery. Most trials were at high risk of bias, due mainly to lack of blinding. We summarise the findings for four key comparisons below. Early (usually one week post injury) versus delayed (after three or more weeks) mobilisation for non-surgically-treated fractures. Five trials (350 participants) made this comparison; however, the available data are very limited. Due to very low-certainty evidence from single trials, we are uncertain of the findings of better shoulder function at one year in the early mobilisation group, or the findings of little or no between-group difference in function at 3 or 24 months. Likewise, there is very low-certainty evidence of no important between-group difference in quality of life at one year. There was one reported death and five serious shoulder complications (1.9% of 259 participants), spread between the two groups, that would have required substantive treatment. Surgical versus non-surgical treatment. Ten trials (717 participants) evaluated surgical intervention for displaced fractures (66% were three- or four-part fractures). There is high-certainty evidence of no clinically important difference between surgical and non-surgical treatment in patient-reported shoulder function at one year (standardised mean difference (SMD) 0.10, 95% confidence interval (CI) -0.07 to 0.27; 7 studies, 552 participants) and two years (SMD 0.06, 95% CI -0.13 to 0.25; 5 studies, 423 participants). There is moderate-certainty evidence of no clinically important between-group difference in patient-reported shoulder function at six months (SMD 0.17, 95% CI -0.04 to 0.38; 3 studies, 347 participants). There is high-certainty evidence of no clinically important between-group difference in quality of life at one year (EQ-5D (0: dead to 1: best quality): mean difference (MD) 0.01, 95% CI -0.02 to 0.04; 6 studies, 502 participants). There is low-certainty evidence of little between-group difference in mortality: one of the 31 deaths was explicitly linked with surgery (risk ratio (RR) 1.35, 95% CI 0.70 to 2.62; 8 studies, 646 participants). There is low-certainty evidence of a higher risk of additional surgery in the surgery group (RR 2.06, 95% CI 1.21 to 3.51; 9 studies, 667 participants). Based on an illustrative risk of 35 subsequent operations per 1000 non-surgically-treated patients, this indicates an extra 38 subsequent operations per 1000 surgically-treated patients (95% CI 8 to 94 more). Although there was low-certainty evidence of a higher overall risk of adverse events after surgery, the 95% CI also includes a slightly increased risk of adverse events after non-surgical treatment (RR 1.46, 95% CI 0.92 to 2.31; 3 studies, 391 participants). Open reduction and internal fixation with a locking plate versus a locking intramedullary nail. Four trials (270 participants) evaluated surgical intervention for displaced fractures (63% were two-part fractures). There is low-certainty evidence of no clinically important between-group difference in shoulder function at one year (SMD 0.15, 95% CI -0.12 to 0.41; 4 studies, 227 participants), six months (Disability of the Arm, Shoulder, and Hand questionnaire (0 to 100: worst disability): MD -0.39, 95% CI -4.14 to 3.36; 3 studies, 174 participants), or two years (American Shoulder and Elbow Surgeons score (ASES) (0 to 100: best outcome): MD 3.06, 95% CI -0.05 to 6.17; 2 studies, 101 participants). There is very low-certainty evidence of no between-group difference in quality of life (1 study), and of little difference in adverse events (4 studies, 250 participants) and additional surgery (3 studies, 193 participants). Reverse total shoulder arthroplasty (RTSA) versus hemiarthroplasty. There is very low-certainty evidence from two trials (161 participants with either three- or four-part fractures) of no or minimal between-group differences in self-reported shoulder function at one year (1 study) or at two to three years' follow-up (2 studies); or in quality of life at one year or at two or more years' follow-up (1 study). Function at six months was not reported. Of 10 deaths reported by one trial (99 participants), one appeared to be surgery-related. There is very low-certainty evidence of a lower risk of complications after RTSA (2 studies). Ten people (6.2% of 161 participants) had a reoperation; all eight cases in the hemiarthroplasty group received a RTSA (very low-certainty evidence). Authors' conclusions: There is high- or moderate-certainty evidence that, compared with non-surgical treatment, surgery does not result in a better outcome at one and two years after injury for people with displaced proximal humeral fractures. It may increase the need for subsequent surgery. The evidence is absent or insufficient for people aged under 60 years, high-energy trauma, two-part tuberosity fractures or less common fractures, such as fracture dislocations and articular surface fractures. There is insufficient evidence from randomised trials to inform the choices between different non-surgical, surgical or rehabilitation interventions for these fractures.
| Original language | English |
|---|---|
| Article number | CD000434 |
| Journal | Cochrane Database of Systematic Reviews |
| Volume | 2022 |
| Issue number | 6 |
| ISSN | 1465-1858 |
| DOIs | |
| Publication status | Published - 2022 |
Bibliographical note
Funding Information:
Subsequent surgery (reasons including non-union, etc) Radiographic outcomes, including avascular necrosis and osteoarthritis Study was partly supported by grants from the Trygg-Hansa Insurance Company (B1/2006) and Stockholm Country Council (20060292). Statement confirming that the authors, their immediate families and affiliated research foundations had not received financial payments or related benefits from any commercial entity in relation to the article.(Independence from the funders regarding stages from data collection onwards declared.) Trial run concurrently with Olerud 2011a. Additional information on randomisation and trial location obtained from Dr Olerud (April 2012). Pain data received May 2012
Funding Information:
The study was supported by the National Science Foundation for Distinguished Young Scholars of China (30901529) and Research Fund for the Doctoral Program of Higher Education (20090072120021) and the Bureau of Public Health, China.
Funding Information:
Subsequent surgery (reasons including deep infection, etc) Radiographic outcomes, including avascular necrosis and osteoarthritis Study was partly supported by grants from the Trygg-Hansa Insurance Company and Stockholm Country Council. Statement confirming that the authors, their immediate families and affiliated research foundations had not received financial payments or related benefits from any commercial entity in relation to the article.(Independence from the funders regarding stages from data collection onwards declared in Olerud 2011b.)
Funding Information:
Funding: work supported by a scientific grant from Mutua Madrileňa Foundation (no. 153192014). The authors declared that they had no conflicts of interest.
Funding Information:
Subsequent referral for operation or substantive treatment Data for economic evaluation: NHS and societal costs The trial was funded by the National Institute for Health Research (UK), Health Technology Assessment Programme (project No. 06/404/53) The authors had no conflict of interests except lead author, Amar Rangan, who reported receiving grants and personal fees from DePuy Ltd; receiving grants from JRI Ltd; and having a UK and European patent pending for a shoulder replacement prosthesis.
Funding Information:
The research was funded by a grant from the Trent Research Scheme (UK).
Funding Information:
The study was "financially supported by Arthrex" (the manufacturer of the CFR-PEEK plate). The conflict of interest statement reported that four of the five listed trial authors received "study support (third party funding) from Arthrex".
Funding Information:
No external funding Declarations of interest: the first author (JEP) had participated in a shoulder fellowship programme that was sponsored by DePuy Synthes Mitek; the senior author (EM) is a consultant and receives royalties from Marquardt Medizintechnik Europe. All other authors declared that they had no competing interests.
Funding Information:
We are grateful to Maria Clarke for running the search updates and deduplicating the search results. We are grateful to the following trial investigators for providing information, including notice of trial publications: Jenna Bardsley, Jeroen Bransen, Stig Brorson, Ron Diercks, Tore Fjalestad, Per Olerud, Catherine Page, Johannes Plath, Darren Roffey and Carlos Torrens. We thank Yuan Chi for translating Li 2015. This project was supported by the National Institute for Health Research (NIHR) via Cochrane Infrastructure funding to the Cochrane Bone, Joint and Muscle Trauma Group. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health. The acknowledgements for former versions of the review are presented in Appendix 8. The Cochrane Bone, Joint and Muscle Trauma (BJMT) Group supported the authors in the development of this Cochrane Review. None of the authors, four (SB, JE, HH, TT) of whom are members of the Cochrane BJMT Group and one (PA) of the Cochrane Incontinence Group, were involved in the editorial process or decision-making for this review. The following people conducted the editorial process for this article: Sign-off Editor (final editorial decision): Michael Brown, Michigan State University College of Human Medicine; Managing Editors (selected peer reviewers, provided comments, collated peer-reviewer comments, provided editorial guidance to authors, edited the article): Lara Kahale and Helen Wakeford, Cochrane Editorial and Methods Department; Editorial Assistant (conducted editorial policy checks and supported editorial team): Leticia Rodrigues, Cochrane Editorial and Methods Department; Copy Editor (copy-editing and production): Faith Armitage, Copy Edit Support team Peer reviewers (provided comments and recommended an editorial decision): Jennifer Hilgart, Cochrane Editorial and Methods Department (methods review); Robin Featherstone, Cochrane Editorial and Methods Department (search review); Amin Sharifan, Department of Pharmaceutical Care, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran (consumer reviewer); and two additional clinical experts whose names were provided to the authors but who did not want to be acknowledged formally. Sign-off Editor (final editorial decision): Michael Brown, Michigan State University College of Human Medicine; Managing Editors (selected peer reviewers, provided comments, collated peer-reviewer comments, provided editorial guidance to authors, edited the article): Lara Kahale and Helen Wakeford, Cochrane Editorial and Methods Department; Editorial Assistant (conducted editorial policy checks and supported editorial team): Leticia Rodrigues, Cochrane Editorial and Methods Department; Copy Editor (copy-editing and production): Faith Armitage, Copy Edit Support team Peer reviewers (provided comments and recommended an editorial decision): Jennifer Hilgart, Cochrane Editorial and Methods Department (methods review); Robin Featherstone, Cochrane Editorial and Methods Department (search review); Amin Sharifan, Department of Pharmaceutical Care, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran (consumer reviewer); and two additional clinical experts whose names were provided to the authors but who did not want to be acknowledged formally.
Funding Information:
There was no statement on direct funding of the trial. The institution of 4 authors received funding from the St Elisabeth Research Foundation, connected with DePuy Orthopaedics, Inc. The authors declared that, individually, they had no commercial associations, such as consultancies, that might pose a conflict of interest.
ID: 326631455