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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00438750
Other study ID # 2006-P-001157
Secondary ID
Status Completed
Phase N/A
First received February 20, 2007
Last updated June 1, 2012
Start date January 2007
Est. completion date May 2010

Study information

Verified date June 2012
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

Operative treatment of distal radius fractures has become commonplace over the last three decades as our understanding of the relationship between the alignment of the distal radius and the function of the wrist and forearm has improved. 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 it would be beneficial to allow early movement of the wrist articulation in an attempt to maximize final outcome. There is a difference in opinion among physicians on the importance of supervision of exercises in the recovery process. Some physicians advocate formal occupational therapy while other physicians believe that appropriate instructions for home exercises are just as good. A common belief is that the motivation of the patient plays an important part in recovery. In addition, Psychological and personality factors, such as pain anxiety, catastrophizing, and depression are strongly related to upper extremity specific health status and may also influence recovery. The goal of this study is to determine which protocol for exercises leads to better outcome in patients treated for distal radius with a volar plate. As a secondary goal and to generate hypotheses for later studies we would like to evaluate the influence of psychosocial factors on both objective (motion, grip strength) and subjective (DASH questionnaire) measures of functional recovery.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 or greater.

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Independent Excercises
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.
Occupational Therapy
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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.
Mean and standard deviations are identical for both arms.
6 months No
Secondary 10-point Ordinal Pain Scale A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever. 6 months No
Secondary Pinch Strength Pinch strength measured with the B&L pinch gauge.
B&L Engineering is the official name of the company (nowhere is there an expansion of this acronym).
6 months No
Secondary Gartland and Werley Score An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion. 6 months No
Secondary Mayo Wrist Score A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent. 6 months No
Secondary Grip Strength Measured with use of a grip meter as the average of three attempts. 6 months No
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