Comparison of Early and Late Therapy for Adults With Operatively Treated Distal Radius Fractures

NCT ID: NCT00438308

Last Updated: 2010-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-05-31

Brief Summary

The purpose of the study is to compare two common ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

Detailed Description

Over the last three decades, operative treatment of distal radius fractures has become increasingly common compared to non-operative treatment. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that, similar to other periarticular fractures, it would be beneficial to allow early movement of the wrist articulation. There is not, however, any data to support this statement. In fact, data regarding external fixation that either immobilizes the wrist or allows wrist motion suggest that early wrist mobilization is not as important as the overall alignment of the bone in terms of final wrist motion. This question is important in patient care and in decision-making regarding these fractures. Additionally, many companies use this claim as a marketing point in spite of the lack of evidence. We consider that good quality data is needed to determine the answer to this issue and to help to resolve the related problems described above.

Conditions

Distal Radius Fractures

Study Design

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

Study Groups

1

Subjects who begin therapy immediately after fracture.

No interventions assigned to this group

2

Subjects delay therapy for 3 weeks after injury.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Gender: Male or female
• Age: Older than 18
• Isolated distal radial fracture
• Fracture treated with volar plates, stable fixation
• Initial treatment within 4 weeks of trauma

Exclusion Criteria

• Complex fractures that require additional or different material than volar plates
• Unstable fractures in which early mobilization is contraindicated

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

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Massachusetts General Hospital

Principal Investigators

David Ring, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

2004-P-002118

Identifier Type: -

Identifier Source: org_study_id