Surgical versus non-surgical treatment of humeral SHAFT fractures compared by a patient-reported outcome: the Scandinavian Humeral diAphyseal Fracture Trial (SHAFT)-a study protocol for a pragmatic randomized controlled trial.

BACKGROUND: The outcome of non-surgical treatment is generally good, but the treatment course can be long and painful with approximately a quarter of the patients acquiring a nonunion. Both surgical and non-surgical treatment can have disabling consequences such as nerve injury, infection, and nonunion. The purpose of the study is to compare patient-reported outcomes after surgical and non-surgical treatment for humeral shaft fractures. METHODS: A pragmatic randomized controlled trial (RCT) is planned with two study groups (SHAFT-Young and SHAFT-Elderly). A total of 287 eligible acute humeral shaft fractures are scheduled to be recruited and randomly allocated to surgical or non-surgical treatment with the option of early crossover due to delayed union. The surgical method within the allocation is decided by the surgeon. The primary outcome is the Disability of Arm, Shoulder, and Hand (DASH) score at 52 weeks, and is assessor blinded. The secondary outcomes are DASH score, EQ-5D-5L, pain assessed by visual analog score, Constant-Murley score including elbow range of motion, and anchor questions collected at all timepoints throughout the trial. All complications will be reported including; infection, nerve or vascular injury, surgical revisions (implant malpositioning, hardware failure, aseptic loosening, and peri-implant fracture), major adverse cardiovascular events, and mortality. DISCUSSION: The SHAFT trial is a pragmatic multicenter RCT, that will compare the effectiveness of the main strategies in humeral shaft fracture treatment. This will include a variety of fracture morphologies, while taking the dilemmas within the population into account by splitting the population by age and providing the orthopedic society with an interval for early crossover surgery. TRIAL REGISTRATION: Clinicaltrials.gov NCT04574336 . Registered on 5 October 2020.

Reverse total shoulder arthroplasty provides better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures in patients aged 70 years or older: a multicenter randomized controlled trial.

BACKGROUND: The most appropriate treatment for displaced multiple-fragment proximal humeral fractures in elderly patients is currently unclear. Reverse total shoulder arthroplasty (rTSA) is a promising treatment option that is being used increasingly. The purpose of this study was to compare the outcome of rTSA vs. hemiarthroplasty (HA) for the treatment of displaced 3- and 4-part fractures in elderly patients. METHODS: This was a multicenter randomized controlled trial. We included patients aged ≥ 70 years with displaced 3- or 4-part proximal humeral fractures between September 2013 and May 2016. The minimum follow-up period was 2 years, with outcome measures including the Constant score (primary outcome), Western Ontario Osteoarthritis of the Shoulder index, EQ-5D (EuroQol 5 Dimensions) index, and range of motion, as well as pain and shoulder satisfaction assessed on a visual analog scale. RESULTS: We randomized 99 patients to rTSA (48 patients) or HA (51 patients). Fifteen patients were lost to follow-up, leaving 41 rTSA and 43 HA patients for analysis. The mean age was 79.5 years, and there were 76 women (90%). The rTSA group had a mean Constant score of 58.7 points compared with 47.7 points in the HA group, with a mean difference of 11.1 points (95% CI, 3.0-18.9 points; P = .007). Compared with HA patients, rTSA patients had greater mean satisfaction with the shoulder (79 mm vs. 63 mm, P = .011), flexion (125° vs. 90°, P < .001), and abduction (112° vs. 83°, P < .001), but there was no difference in Western Ontario Osteoarthritis of the Shoulder index, pain, or EQ-5D index scores. We identified 3 and 4 adverse events in the rTSA and HA groups, respectively. Among patients aged ≥ 80 years (n = 38), there was no difference between rTSA treatment and HA treatment in pain (17 mm vs. 9 mm, P = .17) or shoulder satisfaction (77 mm vs. 74 mm, P = .73). CONCLUSION: We found that rTSA provides better shoulder function than HA as measured with the Constant score, further emphasized by rTSA patients being more satisfied with their shoulder function. The difference appears to be mainly a result of better range of motion (abduction and flexion) in the rTSA group. The results also indicate that patients aged ≥ 80 years benefit less from rTSA than patients aged 70-79 years.

Responsiveness of the EQ-5D in patients with proximal humeral fractures.

BACKGROUND: This study evaluated the internal and external responsiveness of the EuroQol EQ-5D (EuroQol Group, Rotterdam, The Netherlands) health status component, defined as the instrument's ability to capture clinically important changes in patients with a proximal humeral fracture within the context of a prospective study. MATERIALS AND METHODS: To evaluate the internal responsiveness of the EQ-5D, the observed change and the standardized response mean (SRM) in relation to the change in the EQ-5D(index) score were calculated. To calculate external responsiveness, an external criterion (EC) was constructed by using the Disabilities of the Arm, Shoulder and Hand (DASH) score. Receiver operating characteristic (ROC) curves and logistic regression analysis were used in the evaluation. RESULTS: The mean change score from prefracture status to the 4-month follow-up for the EQ-5D was -20.9 and the corresponding SRM was 0.90, indicating good internal responsiveness. The clearly improved or clearly deteriorated patients according to the EC (DASH) reported change scores of approximately 12 points in the EQ-5D, corresponding to moderately strong SRMs, which, together with the results of the ROC analyses and logistic regression, indicated a good external responsiveness. CONCLUSION: The EQ-5D displayed good internal and external responsiveness in patients with proximal humeral fractures and can be recommended for use as a quality of life measure in patients with this particular injury.

Hemiarthroplasty versus nonoperative treatment of displaced 4-part proximal humeral fractures in elderly patients: a randomized controlled trial.

BACKGROUND: The aim of the study was to report the 2-year outcome after a displaced 4-part fracture of the proximal humerus in elderly patients randomized to treatment with a hemiarthroplasty (HA) or nonoperative treatment. PATIENTS AND METHODS: We included 55 patients, mean age 77 (range, 58-92) years, 86% being women. Follow-up examinations were done at 4, 12, and 24 months. The main outcome measures were health-related quality of life (HRQoL) according to the EQ-5D and the DASH and Constant scores. RESULTS: At the final 2-year follow-up the HRQoL was significantly better in the HA group compared to the nonoperative group, EQ-5D (index) score 0.81 compared to 0.65 (P = .02). The results for DASH and pain assessment were both in favor of the HA group, DASH score 30 versus 37 (P = .25) and pain according to VAS 15 versus 25 (P = .17). There were no significant differences regarding the Constant score or range of motion (ROM). Both groups achieved a mean flexion of approximately 90-95° and a mean abduction of 85-90°. The need for additional surgery was low: 3 patients in the HA group and 1 patient in the nonoperative group. CONCLUSION: The results of the study demonstrated a significant advantage in quality of life in favor of HA, as compared to nonoperative treatment in elderly patients with a displaced 4-part fracture of the proximal humerus. The main advantage of HA appeared to be less pain while there were no differences in ROM.

Internal fixation versus nonoperative treatment of displaced 3-part proximal humeral fractures in elderly patients: a randomized controlled trial.

BACKGROUND: The aim of the study was to report the 2-year outcome after a displaced 3-part fracture of the proximal humerus in elderly patients randomized to treatment with a locking plate or nonoperative treatment. PATIENTS AND METHODS: We included 60 patients, mean age 74 years (range, 56-92), 81% being women. The main outcome measures were the Constant and Disabilities of the Arm, Shoulder and Hand (DASH) scores and the health-related quality of life (HRQoL) according to the EQ-5D. RESULTS: At the final 2-year follow-up, the results for range of motion (ROM), function and HRQoL were all in favor of the locking plate group. The mean flexion in the locking plate group was 120° compared to 111° in the nonoperative group (P = .36) and the mean abduction was 114° compared to 106° (P = .28). The corresponding values for the Constant score were 61 versus 58 (P = .64), for DASH 26 versus 35 (P = .19), and the mean EQ-5D (index) score was 0.70 compared to 0.59 (P = .26). In spite of good primary reduction in 86% of the fractures in the locking plate group, 13% of the patients had a fracture complication requiring a major reoperation and 17% had a minor reoperation. CONCLUSION: The results of our study indicate an advantage in functional outcome and HRQoL in favor of the locking plate compared to nonoperative treatment in elderly patients with a displaced 3-part fracture of the proximal humerus, but at the cost of additional surgery in 30% of the patients.

Quality of life and functional outcome after a 2-part proximal humeral fracture: a prospective cohort study on 50 patients treated with a locking plate.

BACKGROUND: The aim of the study was to report the 2-year outcome after a displaced 2-part fracture of the proximal humerus in elderly patients treated with a locking plate, including an assessment of the health-related quality of life (HRQoL). MATERIAL AND METHODS: We included 50 patients, mean age 75 (range, 55-93) years with 80% women. The fracture inclusion criteria were a displacement of the shaft of >50% of its width and/or >45 degrees of angulation. Follow-up examinations were performed at 4, 12, and 24 months. The main outcome measures were the Constant and DASH scores and HRQoL according to the EQ-5D. RESULTS: Eight patients (16%) were re-operated upon during the study period. At the final follow-up the mean Constant score was 61 and the mean DASH score 32. The EQ-5D (index) score decreased from 0.86 before the fracture to 0.62 at 4 months. At 12 months the EQ-5D (index) score was 0.65 and at 24 months 0.68. The values at all follow-ups were significantly lower than before the fracture (P < .001 in all 3 comparisons). CONCLUSION: Locking plates appear to be a good treatment alternative in elderly patients with a displaced 2-part fracture of the surgical neck of the proximal humerus with an acceptable complication rate and an acceptable functional outcome; however, rigorous attention has to be paid to avoid screw penetration. Despite the overall acceptable functional outcome, the patients reported a substantial negative effect upon their HRQoL.