Dataset Information

Is an in-home telerehabilitation program for people with proximal humerus fracture as effective as a conventional face-to face rehabilitation program? A study protocol for a noninferiority randomized clinical trial.

ABSTRACT: BACKGROUND:Proximal humerus fractures can be treated surgically (eg: pinning, plate and screws) or conservatively by wearing a splint or a cast. Following both of these approaches, rehabilitation has proven effective to prevent functional limitations and to re-establish normal shoulder function. However, access to these rehabilitation services and compliance tends to be limited in elderly patients due to travelling difficulties caused by their precarious health status and, in some cases, social and marital status. Since the majority of patients with a proximal humerus fracture are elderly, it becomes relevant to find a new way to offer quick, simple and suitable rehabilitation service. Thus, the use of promising alternative approaches, as in-home telerehabilitation, can enhance access to rehabilitation services for such population. The main objective of the study is to compare the clinical effects of the innovative telerehabilitation approach (TELE group) compared to face-to-face visits to a clinic (CLINIC group) for patients treated for a proximal humerus fracture. METHODS/DESIGN:In this randomized controlled trial, individuals who have had a proximal humerus fracture treated conservatively at the Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie CHUS), and who are returning home will be included. Participants will be recruited during their visit to the emergency ward or outpatient clinic by the medical or research team and will then sign the informed consent form if they are interested to participate in the study. We expect to recruit 52 participants (26 per group). Randomization will be done by a random number generator with sealed envelopes. Each patient will be evaluated before the beginning of the rehabilitation (T1), and immediately after the 2-month intervention (T2). The following outcomes will be measured: 1) upper extremity function (Constant Shoulder Score and Disability of the Arm, Shoulder and Hand questionnaire [DASH]); 2) range of motion (conventional goniometer); 3) user satisfaction (Health Care Satisfaction questionnaire); and 4) cost of services to the public healthcare system. The difference between the two groups will be compared using a t-test or a chi-squared test, and through a cost-effectiveness economic analysis. DISCUSSION:We hypothesize that in-home telerehabilitation will provide a good alternative to conventional rehabilitation, in terms of its efficacy, simplicity, patient satisfaction, and low associated costs. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02425267. April 22(nd), 2015.

SUBMITTER: Cabana F

PROVIDER: S-EPMC5000429 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Is an in-home telerehabilitation program for people with proximal humerus fracture as effective as a conventional face-to face rehabilitation program? A study protocol for a noninferiority randomized clinical trial.

Cabana François F Pagé Catherine C Svotelis Amy A Langlois-Michaud Samuel S Tousignant Michel M

BMC sports science, medicine & rehabilitation 20160826 1

<h4>Background</h4>Proximal humerus fractures can be treated surgically (eg: pinning, plate and screws) or conservatively by wearing a splint or a cast. Following both of these approaches, rehabilitation has proven effective to prevent functional limitations and to re-establish normal shoulder function. However, access to these rehabilitation services and compliance tends to be limited in elderly patients due to travelling difficulties caused by their precarious health status and, in some cases, ...[more]

PMID: 27570627

Similar Datasets

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:BackgroundAs the aging population expands, proximal humerus fractures have become more prevalent. This study aimed to evaluate acute management of proximal humerus fractures in women and men older than the age of 50 years to determine how gender and age have affected definitive treatment selection over the last decade.MethodsPatient records were retrospectively reviewed from a commercially available database, PearlDiver, to identify treatments for proximal humerus fractures between 2010 and 2019. Data were separated by age into two cohorts, patients aged 50-64 years and those aged 65 years and older before stratification by gender. Within each cohort, groups were matched with respect to age, region, and Elixhauser comorbidity index. Logistic regression analyses were performed to determine which gender was associated with a higher risk of undergoing operative treatment, which gender was associated with a higher risk of receiving arthroplasty, and which of the individual surgical operations were more likely given the patient's gender and age.ResultsIn the 50- to 64-year-old cohort, men were less likely to be treated operatively than women (odds ratio [OR]: 0.90). However, men in this cohort had a 31% higher likelihood of receiving an arthroplasty procedure than women when given operative treatment. Specifically, men aged 50 to 64 years were more likely to receive hemiarthroplasty (OR: 1.48) and intramedullary nailing (OR: 1.19) and were less likely to have open reduction internal fixation (ORIF) (OR: 0.71). In the 65 years and older cohort, there was no relationship between gender and the likelihood of operative treatment for a proximal humerus fracture. Men older than 65 years had a 29% lower likelihood of receiving an arthroplasty type procedure than women older than 65 years. In addition, men older than 65 years were more likely to receive ORIF (OR: 1.14) and intramedullary nailing (OR: 1.43) and less likely to receive hemiarthroplasty (OR: 0.86) and reverse total shoulder arthroplasty (OR: 0.66) than similarly aged women.ConclusionBoth age and gender have an association with the definitive treatment patients received for proximal humerus fractures over the last decade. Women younger than 65 years of age were more likely to undergo operative treatment, although once older than 65 years, there was no influence of gender on operative treatment. Men younger than 65 years were more likely to receive arthroplasty and women, more likely to undergo ORIF; however, as patients reached the age of 65 years and older, this finding was reversed such that women were more likely to receive arthroplasty and men, ORIF. Further exploration into these differences could improve decision-making between surgeons and patients.

Project description:Importance:Meta-analyses of randomized clinical trials suggest that the advantages and risks of surgery compared with conservative management as the initial treatment for proximal humerus fracture (PHF) vary, or are heterogeneous across patients. Substantial geographic variation in surgery rates for PHF suggests that the optimal rate of surgery across the population of patients with PHF is unknown. Objective:To use geographic variation in treatment rates to assess the outcomes associated with higher rates of surgery for patients with PHF. Design, Setting, and Participants:This comparative effectiveness research study analyzed all fee-for-service Medicare beneficiaries with proximal humerus fracture in 2011 who were continuously enrolled in Medicare Parts A and B for the 365-day period before and immediately after their index fracture. Data analysis was performed January through June 2019. Exposure:Undergoing 1 of the commonly used surgical procedures in the 60 days after an index fracture diagnosis. Main Outcomes and Measures:Risk-adjusted area surgery ratios were created for each hospital referral region as a measure of local area practice styles. Instrumental variable approaches were used to assess the association between higher surgery rates and adverse events, mortality risk, and cost at 1 year from Medicare's perspective for patients with PHF in 2011. Instrumental variable models were stratified by age, comorbidities, and frailty. Instrumental variable estimates were compared with estimates from risk-adjusted regression models. Results:The final cohort included 72?823 patients (mean [SD] age, 80.0 [7.9] years; 13?958 [19.2%] men). The proportion of patients treated surgically ranged from 1.8% to 33.3% across hospital referral regions in the United States. Compared with conservatively managed patients, surgical patients were younger (mean [SD] age, 80.4 [8.1] years vs 78.0 [7.2] years; P?<?.001) and healthier (Charlson Comorbidity Index score of 0, 14?863 [24.4%] patients vs 3468 [29.1%] patients; Function-Related Indicator score of 0, 20?720 [34.0%] patients vs 4980 [41.8%] patients; P?<?.001 for both), and a larger proportion were women (49?030 [80.5%] patients vs 9835 [82.5%] patients; P?<?.001). Instrumental variable analysis showed that higher rates of surgery were associated with increased total costs ($8913) during the treatment period, increased adverse event rates (a 1-percentage point increase in the surgery rate was associated with a 0.19-percentage point increase in the 1-year adverse event rate; ??=?0.19; 95% CI, 0.09-0.27; P?<?.001), and increased mortality risk (a 1-percentage point increase in the surgery rate was associated with a 0.09-percentage point increase in the 1-year mortality rate; ??=?0.09; 95% CI, 0.04-0.15; P?<?.01). Instrumental variable mortality results were even more striking for older patients and those with higher comorbidity burdens and greater frailty. Risk-adjusted estimates suggested that surgical patients had higher costs (increase of $17?278) and more adverse events (a 1-percentage point increase in the surgery rate was associated with a 0.12-percentage point increase in the 1-year adverse event rate; ??=?0.12; 95% CI, 0.11 to 0.13; P?<?.001) but lower risk of mortality after PHF (a 1-percentage point increase in the surgery rate was associated with a 0.01-percentage point decrease in the 1-year mortality rate; ??=?-0.01; 95% CI, -0.015 to -0.005; P?<?.001). Conclusions and Relevance:This study found that higher rates of surgery for treatment of patients with PHF were associated with increased costs, adverse event rates, and risk of mortality. Orthopedic surgeons should be aware of the harms of extending the use of surgery to more clinically vulnerable patient subgroups.

Project description:BackgroundAlthough 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 findingsThe 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.ConclusionsThis 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 registrationClinicalTrials.gov NCT01246167.

Dataset Information

Is an in-home telerehabilitation program for people with proximal humerus fracture as effective as a conventional face-to face rehabilitation program? A study protocol for a noninferiority randomized clinical trial.

Publications

Is an in-home telerehabilitation program for people with proximal humerus fracture as effective as a conventional face-to face rehabilitation program? A study protocol for a noninferiority randomized clinical trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets