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

Prospective Randomized Comparison of Early and Late Wrist Mobilization After Volar Plate Fixation of a Fracture of the Distal Radius

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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fractures

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.

• Study Type: Observational
• Enrollment (Actual): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from the MGH Hand and Upper Extremith Service

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Subjects who begin therapy immediately after fracture.
2; Subjects delay therapy for 3 weeks after injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
range of motion in degrees of the wrists	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
DASH score	6 months
Likert pain scale	6 months
pinch and grip strength	6 months
Gartland and Werely score	6 months
and Mayo wrist score	6 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: February 20, 2007
• First Submitted That Met QC Criteria: February 21, 2007
• First Posted (Estimate): February 22, 2007

Study Record Updates

• Last Update Posted (Estimate): August 12, 2010
• Last Update Submitted That Met QC Criteria: August 11, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: rehabilitation; DASH questionnaire; distal radius fracture; volar plate fixation
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 2004-P-002118