NCT00438308

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2004

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 12, 2010

Status Verified

August 1, 2010

First QC Date

February 20, 2007

Last Update Submit

August 11, 2010

Conditions

Distal Radius Fractures

Keywords

distal radius fracturerehabilitationvolar plate fixationDASH questionnaire

Outcome Measures

Primary Outcomes (1)

  • range of motion in degrees of the wrists

    6 months

Secondary Outcomes (5)

  • 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

Study Arms (2)

1

Subjects who begin therapy immediately after fracture.

2

Subjects delay therapy for 3 weeks after injury.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the MGH Hand and Upper Extremith Service

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • David Ring, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

December 1, 2004

Study Completion

May 1, 2007

Last Updated

August 12, 2010

Record last verified: 2010-08