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

Background: Fractures 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/design. The 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. Discussion. Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture. Trial registration. The trial is registered at the Netherlands Trial Register (NTR3617)

Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial

Contains fulltext : 96826.pdf (publisher's version ) (Open Access)BACKGROUND: The traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures. Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries. AIM: A prospective, multicentre randomised controlled trial (RCT) will be conducted in 21 hospitals in the Netherlands, comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation. METHODS/DESIGN: A total of 350 patients will be included, between 18 and 60 years of age, with a dislocated midshaft clavicular fracture. The primary outcome is the incidence of non-union, which will be determined with standardised X-rays (Antero-Posterior and 30 degrees caudocephalad view). Secondary outcome will be the functional outcome, measured using the Constant Score. Strength of the shoulder muscles will be measured with a handheld dynamometer (MicroFET2). Furthermore, the health-related Quality of Life score (ShortForm-36) and the Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure will be monitored as subjective parameters. Data on complications, bone union, cosmetic aspects and use of painkillers will be collected with follow-up questionnaires. The follow-up time will be two years. All patients will be monitored at regular intervals over the subsequent twelve months (two and six weeks, three months and one year). After two years an interview by telephone and a written survey will be performed to evaluate the two-year functional and mechanical outcomes. All data will be analysed on an intention-to-treat basis, using univariate and multivariate analyses. DISCUSSION: This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two standardised treatment options for dislocated midshaft clavicular fractures. The gathered data may support the development of a clinical guideline for treatment of clavicular fractures. TRIAL REGISTRATION: Netherlands National Trial Register NTR2399

Reliability and Reproducibility of the OTA/AO Classification for Humeral Shaft Fractures

Objectives: This study aimed to determine interobserver reliability and intraobserver reproducibility of the OTA/AO classification for humeral shaft fractures, and to evaluate differences between fracture types, fracture groups, and surgical specializations. Methods: Thirty observers (25 orthopaedic trauma surgeons and 5 general orthopaedic surgeons) independently classified 90 humeral shaft fractures according to the OTA/AO classification. Patients of 16 years and older were included. Periprosthetic, recurrent, and pathological fractures were excluded. Radiographs were provided in random order, and observers were blinded to clinical information. To determine intraobserver agreement, radiographs were reviewed again after 2 months in a different random order. Agreement was assessed using kappa statistics. Results: Interobserver agreement for the 3 fracture types was moderate (κ = 0.60; 0.59-0.61). It was substantial for type A (κ = 0.77; 0.70-0.84) and moderate for type B (κ = 0.52; 0.46-0.58) and type C fractures (κ = 0.46; 0.42-0.50). Interobserver agreement for the 9 fracture groups was moderate (κ = 0.48; 95% CI, 0.48-0.48). Orthopaedic trauma surgeons had better overall agreement for fracture types, and general orthopaedic surgeons had better overall agreement for fracture groups. Observers classified 64% of fractures identically in both rounds. Intraobserver agreement was substantial for the 3 types (κ = 0.80; 0.77-0.81) and 9 groups (κ = 0.80; 0.77-0.82). Intraobserver agreement showed no differences between surgical disciplines. Conclusions: The OTA/AO classification for humeral shaft fractures has a moderate interobserver and substantial intraobserver agreement for fracture types and groups

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

The Disabilities of the Arm, Shoulder and Hand (DASH) and Constant-Murley scores are commonly used instruments. The DASH is patient-reported, and the Constant-Murley combines a clinician-reported and a patient-reported part. For patients with a humeral shaft fracture, their validity, reliability, responsiveness, and minimal important change (MIC) have not been published. This study evaluated the measurement properties of these instruments in patients who sustained a humeral shaft fracture. The DASH and Constant-Murley instruments were completed 5 times until 1 year after trauma. Pain score, Short Form 36, and EuroQol-5D were completed for comparison. Internal consistency was determined by the Cronbach α. Construct and longitudinal validity were evaluated by assessing hypotheses about expected Spearman rank correlations in scores and change scores, respectively, between patient-reported outcome measures (sub)scales. The smallest detectable change (SDC) was calculated. The MIC was determined using an anchor-based approach. The presence of floor and ceiling effects was determined. A total of 140 patients were included. Internal consistency was sufficient for DASH (Cronbach α = 0.96) but was insufficient for Constant-Murley (α = 0.61). Construct and longitudinal validity were sufficient for both patient-reported outcome measures (>75% of correlations hypothesized correctly). The MIC and SDC were 6.7 (95% confidence interval, 5.0-15.8) and 19.0 (standard error of measurement, 6.9), respectively, for DASH and 6.1 (95% CI -6.8 to 17.4) and 17.7 (standard error of measurement, 6.4), respectively, for Constant-Murley. The DASH and Constant-Murley are valid instruments for evaluating outcome in patients with a humeral shaft fracture. Reliability was only shown for the DASH, making this the preferred instrument. The observed MIC and SDC values provide a basis for sample size calculations for future researc

HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER): a multicenter comparative observational study

Fractures 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. The 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. Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture. The trial is registered at the Netherlands Trial Register (NTR3617

Recovery and functional outcome after radial nerve palsy in adults with a humeral shaft fracture: a multicenter prospective case series

Background: The consequences of radial nerve palsy associated with a humeral shaft fracture are unclear. The aim of this study was to examine the functional recovery of radial nerve palsy, at presentation or postoperatively, in patients with a humeral shaft fracture. Methods: Data from patients who participated in the HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER) study, a multicenter prospective cohort study including adults with a closed humeral shaft fracture Arbeitsgemeinschaft für Osteosynthesefragen (AO) type 12A or 12B, and had radial nerve palsy at presentation or postoperatively, were extracted from the HUMMER database. The primary outcome measure was clinically assessed recovery of motor function of the radial nerve. Secondary outcomes consisted of treatment, functional outcome (Disabilities of the Arm, Shoulder, and Hand and Constant–Murley Score), pain level, quality of life (Short Form-36 and EuroQoL-5D-3L), activity resumption, and range of motion of the shoulder and elbow joint at 12 months after trauma. Results: Three of the 145 nonoperatively treated patients had radial nerve palsy at presentation. One recovered spontaneously and 1 after osteosynthesis. Despite multiple surgical interventions, the third patient had no recovery after entrapment between fracture fragments. Thirteen of the 245 operatively treated patients had radial nerve palsy at presentation; all recovered. Nine other patients had postoperative radial nerve palsy; 8 recovered. One had ongoing recovery at the last follow-up, after nerve release and suture repair due to entrapment under the plate. At 12 months, the functional outcome scores of all patients suggested full recovery regarding functional outcome, pain, quality of life, activity resumption, and range of motion. Conclusion: Radial nerve palsy in patients with a humeral shaft fracture at presentation or postoperatively functionally recovers in 94% and 89%, respectively

Recovery and functional outcome after radial nerve palsy in adults with a humeral shaft fracture: a multicenter prospective case series

Background: The consequences of radial nerve palsy associated with a humeral shaft fracture are unclear. The aim of this study was to examine the functional recovery of radial nerve palsy, at presentation or postoperatively, in patients with a humeral shaft fracture. Methods: Data from patients who participated in the HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER) study, a multicenter prospective cohort study including adults with a closed humeral shaft fracture Arbeitsgemeinschaft für Osteosynthesefragen (AO) type 12A or 12B, and had radial nerve palsy at presentation or postoperatively, were extracted from the HUMMER database. The primary outcome measure was clinically assessed recovery of motor function of the radial nerve. Secondary outcomes consisted of treatment, functional outcome (Disabilities of the Arm, Shoulder, and Hand and Constant–Murley Score), pain level, quality of life (Short Form-36 and EuroQoL-5D-3L), activity resumption, and range of motion of the shoulder and elbow joint at 12 months after trauma. Results: Three of the 145 nonoperatively treated patients had radial nerve palsy at presentation. One recovered spontaneously and 1 after osteosynthesis. Despite multiple surgical interventions, the third patient had no recovery after entrapment between fracture fragments. Thirteen of the 245 operatively treated patients had radial nerve palsy at presentation; all recovered. Nine other patients had postoperative radial nerve palsy; 8 recovered. One had ongoing recovery at the last follow-up, after nerve release and suture repair due to entrapment under the plate. At 12 months, the functional outcome scores of all patients suggested full recovery regarding functional outcome, pain, quality of life, activity resumption, and range of motion. Conclusion: Radial nerve palsy in patients with a humeral shaft fracture at presentation or postoperatively functionally recovers in 94% and 89%, respectively