Surgical treatment with an angular stable plate for complex displaced proximal humeral fractures in elderly patients: a randomized controlled trial

Abstract

Objective: The objective of the study was to evaluate functional outcome, patient self-assessment, and radiographic outcome at 1 year in displaced three- and four-part proximal humeral fractures (OTA group 11-B2 and 11-C2).

Design: Randomized controlled trial.

Setting: Academic medical center.

Patients/participants: Fifty patients aged 60 years or older with displaced three- or four-part proximal humeral fractures and no previous shoulder injuries were randomized either to surgical treatment or to conservative closed treatment. Twenty-five patients were included in each group. Forty-eight patients completed 12-month follow-up. Two surgical patients died within 3 months.

Intervention: The surgically treated group had a standardized surgical treatment with open reduction and internal fixation using an angular stable plate and cerclages. Instructed physical therapy started the third postoperative day. The conservative treatment group had a standardized nonoperative treatment that included closed reduction if displacement between the head and metaphyseal shaft fragment exceeded 50% of the diaphyseal diameter. Physical therapy started on the fifteenth postoperative day.

Main outcome measurements: The main outcome was the mean difference in Constant score between the injured and noninjured shoulder at 12 months. The secondary outcomes were patient self-assessment (American Shoulder and Elbow Surgeons score) and radiographic ratings at 12 months.

Results: At 12 months, mean Constant scores favored conservative treatment by 2.4 points (nonsignificant; P = 0.62). There was no significant difference in mean patient self-assessment. However, radiographic outcomes were significantly better for surgically treated patients.

Conclusion: There is no evidence of a difference in functional outcome at 1-year follow-up between surgical treatment and conservative treatment of displaced proximal humeral fractures in elderly patients.

Trial registration: ClinicalTrials.gov NCT00863473.