Comparison of Early and Late Therapy for Adults With Operatively Treated Distal Radius Fractures
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Purpose
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.
| Condition |
|---|
|
Distal Radius Fractures |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Randomized Comparison of Early and Late Wrist Mobilization After Volar Plate Fixation of a Fracture of the Distal Radius |
- range of motion in degrees of the wrists [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- DASH score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Likert pain scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- pinch and grip strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Gartland and Werely score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- and Mayo wrist score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | December 2004 |
| Study Completion Date: | May 2007 |
| Groups/Cohorts |
|---|
|
1
Subjects who begin therapy immediately after fracture.
|
|
2
Subjects delay therapy for 3 weeks after injury.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients from the MGH Hand and Upper Extremith Service
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | David C Ring, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00438308 History of Changes |
| Other Study ID Numbers: | 2004-P-002118 |
| Study First Received: | February 20, 2007 |
| Last Updated: | August 11, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
distal radius fracture rehabilitation volar plate fixation DASH questionnaire |
Additional relevant MeSH terms:
|
Fractures, Bone Radius Fractures Wounds and Injuries Forearm Injuries Arm Injuries |
ClinicalTrials.gov processed this record on June 18, 2013