Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures

Completed

• Conditions: Proximal Humeral Fractures

• Registration Number: NCT00438633
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.

Detailed Description

Proximal humerus fractures with limited displacement and fractures that occur in older, less active or infirm patients are treated non-operatively. There is a general impression, supported by some data, that better function is obtained with immediate initiation of shoulder exercises. However, there is some concern that this may contribute to nonunion of the fracture and may be unnecessary. Some researchers have demonstrated better outcomes with immediate rehabilitation with pendulum movements. Others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and this delay is associated with lower rates of non-union and malunion occurrence.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-22
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2018-09-14
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-19
• Last Update Submitted: 2019-06-19
• Results First Posted: 2019-06-21
• Last Update Posted: 2019-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Male and Female patients.
• Any race
• Older than 18y
• Diagnosed with proximal humeral fracture clinically and confirmed by imaging studies: X rays and/or CT Scans.
• Any type of proximal humeral fracture according to the Neer or AO classification system.
• Patient should have received non-operative treatment.

Exclusion Criteria

• Patients younger than 18 y.
• Patients with multiple other fractures.
• Patients that have received surgical treatment including closed reduction and percutaneous fixation, open reduction and internal fixation (plates, screws, pins, tension wire bands, cerclage wiring and/or intramedullary nailing) and/or articular shoulder prosthesis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shoulder Flexion	6 months	We measured active forward flexion of the shoulder

Secondary Outcome Measures

Name	Time	Method
External Rotation	3 months, 6 months
Abduction	3 months, 6 months
Disability of the Hand, Shoulder, and Arm Score	3 months, 6 months	Disability of the Hand, Shoulder, and Arm Score (DASH) is a measure of upper extremity physical function, with scores ranging from 0 to 100. A higher score indicates more physical impairment.
Shoulder Pain Likert Scores	3 months, 6 months	Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States