Question:
In older patients with a displaced four-part fracture of the proximal part of the humerus, does hemiarthroplasty improve quality of life and functional outcomes more than nonoperative treatment does?
Design:
Randomized (allocation concealed), blinded (outcome assessor), controlled trial with two years of follow-up.
Setting:
Stockholm Söder Hospital in Stockholm, Sweden.
Patients:
Fifty-five patients (mean age, seventy-seven years; 86% women) who had an acute, displaced four-part fracture of the proximal part of the humerus. Other inclusion criteria were age ≥55 years, fracture caused by a simple fall, no previous shoulder problems, independent living, and no cognitive impairment. The fracture had to have displacement of the shaft of >10 mm or >45° of angulation in relation to the humeral head fragment, and a displacement of the greater and lesser tuberosity of >10 mm in relation to the head fragment. Patients with a completely displaced humeral shaft in relation to the head fragment or a valgus-impacted four-part fracture were excluded. Forty-nine patients (89%) were available for the twenty-four month follow-up.
Intervention:
Patients were allocated to hemiarthroplasty (n = 27) or nonoperative treatment (n = 28). Surgery was performed by one of two orthopaedic surgeons within a mean of six days after the injury using a modified beach-chair position and a deltopectoral surgical approach. The fracture interval was opened, the humeral head fragment was removed, and the shaft was reamed. The height and retroversion of the prosthesis were defined with an extramedullary device and the stem was cemented in place. Cancellous bone graft from the head fragment was placed between the shaft and tuberosities to promote union, and the tuberosities were reduced and fixed with nonabsorbable sutures. The Global Fx prosthesis (DePuy, Sollentuna, Sweden) was used in all surgical procedures. Patients were referred to a physiotherapist, wore a sling for six weeks, and began pendulum exercises and passive elevation and abduction up to 90° one day after surgery. Patients in the nonoperative group wore a sling for two weeks then were referred to a physiotherapist and began pendulum exercises and passive elevation and abduction up to 90°.
Main outcome measures:
The primary outcome was health-related quality of life assessed with use of the EuroQol (EQ)-5D index, which rated five dimensions (mobility, self-care, usual activities, pain and/or discomfort, and anxiety and/or depression) as no problem, some problems, or major problems. The EQ-5D score ranged from 0 (worst possible state of health) to 1 (best possible). The secondary outcome was functional outcome assessed with use of the Constant score and the Disabilities of the Arm, Shoulder and Hand (DASH) score. The Constant score evaluated shoulder function in four dimensions (pain, 15 points; activities of daily living, 20 points; shoulder range of motion, 40 points; and strength, 25 points) and the DASH score measured upper extremity disability and symptoms using the thirty-item disability/symptom scale (range, 0 [no disability] to 100 [most severe disability]). Pain was assessed on a 100-point visual analog scale (VAS; 0 = no pain, and 100 = worst possible pain).
Main results:
Analysis was by intention to treat. The mean prefracture EQ-5D score was 0.87 in both treatment groups. At twenty-four months, the score was 0.81 in the hemiarthroplasty group compared with 0.65 in the nonoperative group (p = 0.02). The twenty-four-month results for the Constant and DASH scores showed no significant difference between the hemiarthroplasty and nonoperative groups (48.3 versus 49.6, p = 0.81, and 30.2 versus 36.9, p = 0.25, respectively). The mean pain scores according to the VAS did not differ between the hemiarthroplasty and nonoperative groups (15 versus 25, p = 0.17). Three patients (11%) in the hemiarthroplasty group required additional surgery during the second year of follow-up. In the nonoperative group, one patient (4%) required surgery one month after randomization and one patient had a fracture nonunion but declined surgical treatment.
Conclusion:
In older patients with a displaced four-part fracture of the proximal part of the humerus, hemiarthroplasty improved health-related quality of life but not functional outcome more than nonoperative treatment did.
The well-designed study by Olerud et al. provides useful information by considering important potential confounding variables and increasing the homogeneity of the study group by excluding four-part fractures with complete displacement of the humeral shaft and valgus-impacted four-part fractures. While the Constant and DASH scores did not show any differences, the EQ-5D score was significantly better in the hemiarthroplasty group and the difference was even greater during the second year of follow-up. There was no difference in shoulder motion between the two groups. This is important information that should be discussed with patients as they decide which treatment option to choose.
In evaluating these results, first (and a minor issue), the authors could have used additional reviewers to classify the fractures to decrease the potential effect of interobserver variability when using the Neer classification. Second, the study was possibly underpowered to determine differences between groups with regard to the Constant and DASH scores. Third, this study did not include open reduction and internal fixation with use of a plate. However, a recent randomized controlled trial1 compared nonoperative management and open reduction and internal fixation with use of an angular plate in complex proximal humeral fractures in elderly patients and found no difference in functional outcome at one year following the injury, suggesting that operative management is not the “answer” for all displaced fractures. Fourth, the results of this study cannot be extrapolated to the reverse shoulder arthroplasty, which needs further evaluation as a treatment for these fractures.
In conclusion, the results of this trial indicate that hemiarthroplasty is currently the right treatment for patients with four-part proximal humeral fractures.