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

NCT ID: NCT00438633

Last Updated: 2019-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2014-03-31

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.

Conditions

Proximal Humeral Fractures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early Therapy

Subjects who begin therapy immediately after diagnosis of injury.

No interventions assigned to this group

Late Therapy

Subjects who delay therapy for 3 weeks after diagnosis of injury.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Neal Chung-Jen Chen

Principal Investigator; Hand Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neal Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

Reference Type: DERIVED

PMID: 35727196 (View on PubMed)

Other Identifiers

2004-P-002235

Identifier Type: -

Identifier Source: org_study_id