Functional and Clinical Outcomes After Plate Osteosynthesis Versus Intramedullary Nailing of a Humeral Shaft Fracture:The Results of the HUMMER Multicenter, Prospective Cohort Study

BACKGROUND: Plate osteosynthesis (referred to throughout as plating) and intramedullary nailing (referred to throughout as nailing) are the most common operative strategies for humeral shaft fractures. However, it is undecided which treatment is more effective. This study aimed to compare functional and clinical outcomes of these treatment strategies. We hypothesized that plating would result in an earlier recovery of shoulder function and fewer complications. METHODS: From October 23, 2012, to October 3, 2018, adults with a humeral shaft fracture, OTA/AO type 12A or 12B, were enrolled in a multicenter, prospective cohort study. Patients were treated with plating or nailing. Outcome measures included the Disabilities of the Arm, Shoulder and Hand (DASH) score, Constant-Murley score, ranges of motion of the shoulder and elbow, radiographic healing, and complications until 1 year. Repeated-measure analysis was done with correction for age, sex, and fracture type. RESULTS: Of the 245 included patients, 76 were treated with plating and 169 were treated with nailing. Patients in the plating group were younger, with a median age of 43 years compared with 57 years for the nailing group (p &lt; 0.001). The mean DASH score after plating improved faster over time, but did not differ significantly from the score after nailing at 12 months (11.7 points [95% confidence interval (CI), 7.6 to 15.7 points]) for plating and 11.2 points [95% CI, 8.3 to 14.0 points] for nailing). The Constant-Murley score and shoulder abduction, flexion, external rotation, and internal rotation displayed a significant treatment effect (p treatment ≤ 0.001), in favor of plating. The plating group had 2 implant-related complications, whereas the nailing group had 24, including 13 nail protrusions and 8 screw protrusions. Plating resulted in more postoperative temporary radial nerve palsy (8 patients [10.5%] compared with 1 patient [0.6%]; p &lt; 0.001) and a trend toward fewer nonunions (3 patients [5.7%] compared with 16 patients [11.9%]; p = 0.285) than nailing. CONCLUSIONS: Plating of a humeral shaft fracture in adults results in faster recovery, especially of shoulder function. Plating was associated with more temporary nerve palsies, but fewer implant-related complications and surgical reinterventions, than nailing. Despite heterogeneity in implants and surgical approach, plating seems to be the preferred treatment option for these fractures. LEVEL OF EVIDENCE: Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.</p

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

Background 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. Methods 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. Results 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. Conclusions 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 research

Functional and clinical outcome after operative versus nonoperative treatment of a humeral shaft fracture (HUMMER): results of a multicenter prospective cohort study

Purpose: The best treatment of humeral shaft fractures in adults is still under debate. This study aimed to compare functional and clinical outcome of operative versus nonoperative treatment in adult patients with a humeral shaft fracture. We hypothesized that operative treatment would result in earlier functional recovery. Methods: From October 23, 2012 to October 03, 2018, adults with a humeral shaft fracture AO type 12A or 12B were enrolled in a prospective cohort study in 29 hospitals. Patients were treated operatively or nonoperatively. Outcome measures were the Disabilities of the Arm, Shoulder, and Hand score (DASH; primary outcome), Constant–Murley score, pain (Visual Analog Score, VAS), health-related quality of life (Short Form-36 (SF-36) and EuroQoL-5D-3L (EQ-5D)), activity resumption (Numeric Rating Scale, NRS), range of motion (ROM) of the shoulder and elbow joint, radiologic healing, and complications. Patients were followed for one year. Repeated measure analysis was done with correction for age, gender, and fracture type. Results: Of the 390 included patients, 245 underwent osteosynthesis and 145 were primarily treated nonoperatively. Patients in the operative group were younger (median 53 versus 62 years; p < 0.001) and less frequently female (54.3% versus 64.8%; p = 0.044). Superior results in favor of the operative group were noted until six months follow-up for the DASH, Constant–Murley, abduction, anteflexion, and external rotation of the shoulder, and flexion and extension of the elbow. The EQ-US, and pronation and supination showed superior results for the operative group until six weeks follow-up. Malalignment occurred only in the nonoperative group (N = 14; 9.7%). In 19 patients with implant-related complications (N = 26; 10.6%) the implant was exchanged or removed. Nonunion occurred more often in the nonoperative group (26.3% versus 10.10% in the operative group; p < 0.001). Conclusion: Primary osteosynthesis of a humeral shaft fracture (AO type 12A and 12B) in adults is safe and superior to nonoperative treatment, and should therefore be the treatment of choice. It is associated with a more than twofold reduced risk of nonunion, earlier functional recovery and a better range of motion of the shoulder and elbow joint than nonoperative treatment. Even after including the implant-related complications, the overall rate of complications as well as secondary surgical interventions was highest in the nonoperative group. Trial registration: NTR3617 (registration date 18-SEP-2012)

Economic evaluation of operative versus nonoperative treatment of a humeral shaft fracture: economic analyses alongside a multicenter prospective cohort study (HUMMER)

Purpose: Operative treatment of a humeral shaft fracture results in faster recovery than nonoperative treatment. The cost-effectiveness, in terms of costs per Quality-Adjusted Life Year (QALY) gained (Dutch threshold €20,000-€80,000) or minimal important change (MIC) in disability reduced (DASH 6.7), is unknown. The aim of this study was to determine cost-utility and cost-effectiveness of operative versus nonoperative treatment in adults with a humeral shaft fracture type 12A or 12B. Methods: This study was performed alongside a multicenter prospective cohort study. Costs for health care and lost productivity until one year after trauma were calculated. The incremental cost-utility ratio (ICUR) was reported in costs per QALY (based on the EuroQoL-5D-3L (EQ-5D)) gained. The incremental cost-effectiveness ratio (ICER) was reported in costs per MIC (based on the DASH score at three months) reduced. Results: Overall, 245 patients were treated operatively and 145 nonoperatively. In the operative group, the mean total costs per patient (€11,925 versus €8793; p < 0.001) and QALYs (0.806 versus 0.778; p < 0.001) were higher. The ICUR of operative treatment was €111,860 per QALY gained (i.e., €3132/0.028). The DASH was 7.3 points (p < 0.001) lower in the operative group. The ICER of operative treatment was €2880 per MIC in disability reduced (i.e., €3132/7.3*6.7). Conclusion: Due to the limited effect of treatment on quality of life measured with the EQ-5D, the ICUR of operative treatment (€111,860 per QALY gained) exceeds the threshold. However, the incremental costs of €2880 per clinically meaningful difference in DASH are much lower and suggest that operative treatment for a humeral shaft fracture is cost-effective

The reliability and reproducibility of the Hertel classification for comminuted proximal humeral fractures compared with the Neer classification

The Neer classification is the most commonly used fracture classification system for proximal humeral fractures. Inter- and intra-observer agreement is limited, especially for comminuted fractures. A possibly more straightforward and reliable classification system is the Hertel classification. The aim of this study was to compare the inter- and intra-observer variability of the Hertel with the Neer classification in comminuted proximal humeral fractures. Four observers evaluated blinded radiographic images (X-rays, CT-scans, and CT-scans with 3D-reconstructions) of 60 patients. After at least two months classification was repeated. Inter-observer agreement on plain X-rays was fair for both Hertel (κ = 0.39; 95% CI 0.23-0.62) and Neer (κ = 0.29; 0.09-0.42). Inter-observer agreement on CT-scans was substantial (κ = 0.63; 0.56-0.72) for Hertel and moderate for Neer (κ = 0.51; 0.29-0.68). Inter-observer agreement on 3D-reconstructions was moderate for both Hertel (κ = 0.60; 0.53-0.72) and Neer (κ = 0.51; 0.39-0.58). Intra-observer agreement on plain X-rays was fair for both Hertel (κ = 0.38; 0.27-0.59) and Neer (κ = 0.40; 0.15-0.52). Intra-observer agreement on CT-scans was moderate for both Hertel (κ = 0.50; 0.38-0.66) and Neer (κ = 0.42; 0.35-0.52). Intra-observer agreement on 3D-reconstructions was moderate for Hertel (κ = 0.55; 0.45-0.64) and substantial for Neer (κ = 0.63; 0.48-0.79). The Hertel and Neer classifications showed a fair to substantial inter- and intra-observer agreement on the three diagnostic modalities used. Although inter-observer agreement was highest for Hertel classification on CT-scans, Neer classification had the highest intra-observer agreement on 3D-reconstructions. Data of this study do not confirm superiority of either classification system for the classification of comminuted proximal humeral fracture

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

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

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

Publisher Correction: Economic evaluation of operative versus nonoperative treatment of a humeral shaft fracture: economic analyses alongside a multicenter prospective cohort study (HUMMER) (European Journal of Trauma and Emergency Surgery, (2022), 10.1007/s00068-022-02160-1)

In this article, the order that the authors appeared in the author list was incorrect. The correct order is: Saskia H. Van Bergen1 · Esther M. M. Van Lieshout1 · Kiran C. Mahabier1 · Alexandra J. L. M. Geraerds2 · Suzanne Polinder2 · Dennis Den Hartog1 · Michael H. J. Verhofstad1 · on behalf of the HUMMER Investigators