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

Distal Radius Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438308
• Other study ID #: 2004-P-002118
• Status: Completed
• Phase: N/A
• First received: February 20, 2007
• Last updated: August 11, 2010
• Start date: December 2004
• Est. completion date: May 2007

Study information

• Verified date: August 2010
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	range of motion in degrees of the wrists		6 months	No
Secondary	DASH score		6 months	No
Secondary	Likert pain scale		6 months	No
Secondary	pinch and grip strength		6 months	No
Secondary	Gartland and Werely score		6 months	No
Secondary	and Mayo wrist score		6 months	No