NCT00438750

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2007

Completed
2 months 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
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 28, 2012

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

3.3 years

First QC Date

February 20, 2007

Results QC Date

March 27, 2012

Last Update Submit

June 1, 2012

Conditions

Keywords

distal radius fracturerehabilitationvolar plate fixationDASH questionnaire

Outcome Measures

Primary Outcomes (1)

  • Range of Motion in Degrees of the Wrists

    Mean arc of wrist flexion and extension six months after surgery. Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees.

    6 months

Secondary Outcomes (6)

  • Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

    6 months

  • 10-point Ordinal Pain Scale

    6 months

  • Pinch Strength

    6 months

  • Gartland and Werley Score

    6 months

  • Mayo Wrist Score

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Independent Home Exercises

EXPERIMENTAL

Subjects who learn their therapy exercises from the surgeon and practice them independently at home.

Other: Independent Excercises

Formal Therapy

EXPERIMENTAL

Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.

Other: Occupational Therapy

Interventions

Subjects provided with wrist splint and instructions for independent exercises to perform at home on their own. Subjects were advised to perform exercises as often as possible, but at least three to four times a day for a minimum of thirty minutes. There was no formal strengthening program.

Independent Home Exercises

Subjects were prescribed formal occupational therapy with supervised exercises to regain digit, wrist, and forearm motion and to strengthen the hand. The content, frequency, and duration of the rehabilitation program were at the discretion of the treating hand therapist.

Formal Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or greater.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Results Point of Contact

Title
David Ring, MD, PhD
Organization
Orthopaedic Hand and Upper Extremity Service, Massachusetts General Hospital

Study Officials

  • David Ring, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Director of Research, Hand Service

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

January 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 8, 2012

Results First Posted

May 28, 2012

Record last verified: 2012-06

Locations