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Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial.

ABSTRACT: BACKGROUND:Although increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures. METHODS AND FINDINGS:The NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or older with displaced (more than 1 cm or 45 degrees) 2-part surgical or anatomical neck proximal humerus fracture were randomly assigned in a 1:1 ratio to undergo either operative treatment with a locking plate or non-operative treatment. The mean age of patients was 72 years in the non-operative group and 73 years in the operative group, with a female sex distribution of 95% and 87%, respectively. Patients were recruited between February 2011 and April 2016. The primary outcome measure was Disabilities of Arm, Shoulder, and Hand (DASH) score at 2-year follow-up. Secondary outcomes included Constant-Murley score, the visual analogue scale for pain, the quality of life questionnaire 15D, EuroQol Group's 5-dimension self-reported questionnaire EQ-5D, the Oxford Shoulder Score, and complications. The mean DASH score (0 best, 100 worst) at 2 years was 18.5 points for the operative treatment group and 17.4 points for the non-operative group (mean difference 1.1 [95% CI -7.8 to 9.4], p = 0.81). At 2 years, there were no statistically or clinically significant between-group differences in any of the outcome measures. All 3 complications resulting in secondary surgery occurred in the operative group. The lack of blinding in patient-reported outcome assessment is a limitation of the study. Our assessor physiotherapists were, however, blinded. CONCLUSIONS:This trial found no significant difference in clinical outcomes at 2 years between surgery and non-operative treatment in patients 60 years of age or older with displaced 2-part fractures of the proximal humerus. These results suggest that the current practice of performing surgery on the majority of displaced proximal 2-part fractures of the humerus in older adults may not be beneficial. TRIAL REGISTRATION:ClinicalTrials.gov NCT01246167.

SUBMITTER: Launonen AP

PROVIDER: S-EPMC6638737 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial.

Launonen Antti P AP Sumrein Bakir O BO Reito Aleksi A Lepola Vesa V Paloneva Juha J Jonsson Kenneth B KB Wolf Olof O Ström Peter P Berg Hans E HE Felländer-Tsai Li L Jansson Karl-Åke KÅ Fell Daniel D Mechlenburg Inger I Døssing Kaj K Østergaard Helle H Märtson Aare A Laitinen Minna K MK Mattila Ville M VM

PLoS medicine 20190718 7

<h4>Background</h4>Although increasingly used, the benefit of surgical treatment of displaced 2-part proximal humerus fractures has not been proven. This trial evaluates the clinical effectiveness of surgery with locking plate compared with non-operative treatment for these fractures.<h4>Methods and findings</h4>The NITEP group conducted a superiority, assessor-blinded, multicenter randomized trial in 6 hospitals in Finland, Estonia, Sweden, and Denmark. Eighty-eight patients aged 60 years or ol ...[more]

PMID: 31318863

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Project description:BACKGROUND:Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodological concerns however limit the generalizability of these conclusions and as a result, management of these fractures remains a controversy. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined. METHODS:We will conduct a prospective, single blind randomized controlled parallel arm trial to compare non-operative management of proximal humerus fractures with open reduction and internal fixation using locked plating technology. One-hundred and sixty patients > age 60 with acute 3- or 4- part proximal humerus fractures will be randomized to either open reduction and internal fixation with locked plating technology or non-operative management treatment arms. The primary outcome measure is the Constant Score at 24 months post-operative. Secondary outcome measures include the American Shoulder and Elbow Surgeon's Score (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score and IPAQ for the elderly score. Further outcome measures include assessment of the initial classification, displacement and angulation and the quality of surgical reduction via a standard computed tomography (CT) scan; rates of non-union, malunion, arthrosis, osteopenia or other complications including infection, nerve injury, intra-articular screw penetration, reoperation rates and hospital re-admission rates. DISCUSSION:The results of this trial will provide Level 1 evidence to guide decision-making in the treatment of proximal humerus fractures in the elderly population. TRIAL REGISTRATION:ClinicalTrials.gov NCT02362100 . Registered 5 Feb 2015.

Project description:BackgroundProximal humerus fractures (PHF) are common and painful injuries, with the majority resulting from falls from a standing height. As with other fragility fractures, its age-specific incidence is increasing. Surgical treatment with hemiarthroplasty (HA) and reverse shoulder arthroplasty (RSA) have been increasingly used for displaced 3- and 4-part fractures despite a lack of good quality evidence as to whether one type of arthroplasty is superior to the other, and whether surgery is better than non-surgical management. The PROFHER-2 trial has been designed as a pragmatic, multicentre randomised trial to compare the clinical and cost-effectiveness of RSA vs HA vs Non-Surgical (NS) treatment in patients with 3- and 4-part PHF.MethodsAdults over 65 years of age presenting with acute radiographically confirmed 3- or 4-part fractures, with or without associated glenohumeral joint dislocation, who consent for trial participation will be recruited from around 40 National Health Service (NHS) Hospitals in the UK. Patients with polytrauma, open fractures, presence of axillary nerve palsy, pathological (other than osteoporotic) fractures, and those who are unable to adhere to trial procedures will be excluded. We will aim to recruit 380 participants (152 RSA, 152 HA, 76 NS) using 2:2:1 (HA:RSA:NS) randomisation for 3- or 4-part fractures without joint dislocation, and 1:1 (HA:RSA) randomisation for 3- or 4-part fracture dislocations. The primary outcome is the Oxford Shoulder Score at 24 months. Secondary outcomes include quality of life (EQ-5D-5L), pain, range of shoulder motion, fracture healing and implant position on X-rays, further procedures, and complications. Independent Trial Steering Committee and Data Monitoring Committee will oversee the trial conduct, including the reporting of adverse events and harms.DiscussionThe PROFHER-2 trial is designed to provide a robust answer to guide the treatment of patients aged 65 years or over who sustain 3- and 4-part proximal humeral fractures. The pragmatic design and recruitment from around 40 UK NHS hospitals will ensure immediate applicability and generalisability of the trial findings. The full trial results will be made available in a relevant open-access peer-reviewed journal.Trial registrationISRCTN76296703. Prospectively registered on 5th April 2018.

Project description:BackgroundProximal humerus fractures are among the most common presenting fractures to orthopedic surgeons in the USA. Hypoalbuminemia is accepted as a nutrition marker associated with post-operative complications following common orthopedic interventions.Questions/purposesThus, the authors sought to (1) describe the national demographic trends of patients undergoing surgical fixation for proximal humerus fracture and (2) investigate the association between pre-operative hypoalbuminemia, a malnutrition marker, and post-operative complications within 1 year of surgical intervention.MethodsThe PearlDiver Humana Claims Database was queried to identify a nationally representative cohort of patients who underwent surgical intervention for proximal humerus fractures from 2008 to 2015. Demographic and comorbid characteristics were collected. Pearson's χ-squared analysis was used to compare rates of 90-day and 1-year outcomes between hypoalbuminemia (albumin ≤ 3.5 mg/dL) and control groups. Multivariate logistic regression was then used to determine the isolated effect that hypoalbuminemia had on post-operative outcomes.ResultsOf the 3337 patients identified, 919 (27.5%) had available serum albumin data. Seventy (7.6%) patients had hypoalbuminemia. Hypoalbuminemia was more likely to be associated with post-operative sepsis (7.1% vs. 1.5%, respectively) and pneumonia (15.7% vs. 4.6) compared with controls. Additionally, hypoalbuminemia was associated with increased 90-day rates of discharge to extended care (4.3% vs. 0.8), emergency room visits (38.6% vs. 21.7), and total cost ($24,051.96 ± 24,972.74 vs. $15,429.74 ± 24,492.30).ConclusionOur study suggests hypoalbuminemia is associated with an increased risk of complications, specifically pneumonia and sepsis, and total health care costs in patients undergoing surgery for proximal humerus fractures. These findings provide insight for individualized patient care that will aid in evaluating the potential risk of surgical complications in an effort to improve outcomes and reduce costs.

Project description:IntroductionCement augmentation of the proximal humerus internal locking system (PHILOS) screws might reduce complication rates in osteoporotic bones. This study compared the risk of mechanical failure during the first year after PHILOS™ treatment of proximal humerus fractures (PHF) without (control group) and with (augmented group) screw augmentation. Secondary objectives were to report shoulder functions, quality of life (QoL), adverse events (AEs), and reoperation rates.Materials and methodsThis multicenter randomized trial enrolled patients aged ≥ 65 years with displaced/unstable PHF from eight European centers. Randomization was performed during surgery through sealed opaque envelopes. Mechanical failures were assessed by two independent reviewers via radiographs, shoulder function by Quick DASH, SPADI, and Constant Murley scores, and QoL by EQ-5D. Follow-ups were planned at postoperative 6 weeks, 3, 6, and 12 months.ResultsThe preliminary analysis of 6-week radiographs of the first 59 enrolled patients suggested a mechanical failure rate lower than expected and the difference between groups was too small to be detected by the planned sample size of 144. The trial was prematurely terminated after 67 patients had been enrolled: 34 (27 eligible) in the control group and 33 (29 eligible) in the augmented group. Follow-ups were performed as planned. Nine patients had mechanical failures and the failure rates (95% CI) were: augmented group, 16.1% (5.5; 33.7); control group, 14.8% (4.2; 33.7); the relative risk (95% CI) for the augmented group was 1.09 (0.32; 3.65) compared to the control group (p = 1.000). No statistically significant differences in shoulder function, QoL, and AEs were observed between study groups at 1 year. Nine patients (15.8%) underwent a revision.ConclusionsDue to premature termination, the study was underpowered. A larger study will be necessary to determine if cement augmentation lowers the risk of mechanical failure rate.

Project description:INTRODUCTION:In locked plate fixation of proximal humerus fractures, the calcar is an important anchor point for screws providing much-needed medial column support. Most locking plate implants utilize a fixed-trajectory locking screw to achieve this goal. Consequently, adjustments of plate location to account for patient-specific anatomy may result in a screw position outside of the calcar. To date, little is known about the consequences of "missing" the calcar during plate positioning. This study sought to characterize the biomechanics associated with proximal and distal placement of locking plates in a two-part fracture model. MATERIALS AND METHODS:This experiment was performed twice, first with elderly cadaveric specimens and again with osteoporotic sawbones. Two-part fractures were simulated and specimens were divided to represent proximal, neutral, and distal plate placements. Non-destructive torsional and axial compression tests were performed prior to an axial fatigue test and a ramp to failure. Torsional stiffness, axial stiffness, humeral head displacement and stiffness during fatigue testing, and ultimate load were compared between groups. RESULTS:Cadavers: Proximal implant placement led to trends of decreased mechanical properties, but there were no significant differences found between groups. Sawbones: Distal placement increased torsional stiffness in both directions (p?=?0.003, p?=?0.034) and axial stiffness (p?=?0.018) when compared to proximal placement. Distal placement also increased torsional stiffness in external rotation (p?=?0.020), increased axial stiffness (p?=?0.024), decreased humeral head displacement during fatigue testing, and increased stiffness during fatigue testing when compared to neutral placement. DISCUSSION:The distal and neutral groups had similar mechanical properties in many cadaveric comparisons while the proximal group trended towards decreased construct stiffness. RESULTS:from the Sawbones model were more definitive and provided further evidence that proximal calcar screw placements are undesirable and distal implant placement may provide improved construct stability. CONCLUSION:Successful proximal humerus fracture reconstruction is inherent upon anatomic fracture reduction coupled with medial column support. Results from this experiment suggest that missing the calcar proximally is deleterious to fixation strength, while it is safe, and perhaps even desirable, to aim slightly distal to the intended target.

Project description:STUDY DESIGN:Cost-effectiveness analysis. OBJECTIVE:To examine the cost-effectiveness of operative versus non-operative treatment of type-II odontoid fractures in patients older than 64 years old. SUMMARY OF BACKGROUND DATA:Significant controversy exists regarding the optimum treatment of geriatric patients with type-II odontoid fractures. Operative treatment leads to lower rates of non-union but carries surgical risks. Non-operative treatment does not carry surgical risks but has higher non-union rates. METHODS:A decision-analytic model was created to compare operative and non-operative treatment of type-II odontoid fractures among three age cohorts (65-74, 75-84, >84) based on expected costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs; cost per QALY gained). Age-specific mortality rates for both treatments, costs for treatment, and complication rates were taken from the literature, and data from 2010 US life tables were used for age-specific life expectancy. Costs of complications were estimated using data obtained at a level-I trauma center using micro-costing. Sensitivity analyses of all model parameters were conducted. RESULTS:Among the 65- to 74-year-old cohort, operative treatment was more costly ($53,407 vs. $30,553) and more effective (12.00 vs. 10.11 QALY), with an ICER of $12,078/QALY. Among the 75- to 84-year-old cohort, operative treatment was more costly ($51,308 vs. $29,789) and more effective (6.85 vs. 6.31 QALY), with an ICER of $40,467/QALY. Among the over-84 cohort, operative treatment was dominated by non-operative treatment as it was both more costly ($45,978 vs. $28,872) and less effective (2.48 vs. 3.73 QALY). The model was robust to sensitivity analysis across reasonable ranges for utility of union, disutility of complications and delayed surgery, and probabilities of non-union and complications. CONCLUSION:Operative treatment is cost-effective in patients age 65 to 84 when using $100,000/QALY as a benchmark but less effective and more costly than non-operative treatment in patients older than 84 years. LEVEL OF EVIDENCE:2.

Dataset Information

Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial.

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Operative versus non-operative treatment for 2-part proximal humerus fracture: A multicenter randomized controlled trial.

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