HUMeral Shaft Fractures: MEasuring Recovery after Operative versus Non-operative Treatment (HUMMER): a multicenter comparative observational study

Abstract

BackgroundFractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery.Methods/designThe design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective.DiscussionSuccessful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture.Trial registrationThe trial is registered at the Netherlands Trial Register (NTR3617).

Reliability, validity, responsiveness, and minimal important change of the Disabilities of the Arm, Shoulder and Hand and Constant-Murley scores in patients with a humeral shaft fracture

“…The study protocol for this trial has been published elsewhere. 16 The medical research ethics committees of all hospitals approved this study, and all patients provided signed informed consent.…”

American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score: a study protocol for the translation and validation of the Dutch language version

“…2 The SF-36 is a generic health status questionnaire that gives an indication of health-related quality of life. [20][21][22][23][24][25][26][27] The SF-36 consists of 36 items (questions) and provides scores on eight dimensions (subscales): physical functioning (PF), role limitations due to physical health problems (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE) and general mental health (MH). These eight domains are combined into a physical component summary (PCS) and a mental component summary (MCS).…”

Humeral shaft fracture

“…Given that this problem will likely not be answered through a prospective randomized trial, large observational trials are underway (Mahabier et al, 2014). Given that this problem will likely not be answered through a prospective randomized trial, large observational trials are underway (Mahabier et al, 2014).…”