A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness

Not Applicable

Completed

• Conditions: Post-traumatic Stiff Elbows
• Interventions: Device: Static-Progressive Splint; Device: Dynamic Splint

• Registration Number: NCT01241916
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Primary Question: "When splinting is used to improve motion in post-traumatic stiff elbows, is there a significant difference in gains in motion achieved between static progressive or dynamic splint approaches?"

Secondary Question: "Is there a significant difference in patient compliance with static progressive versus dynamic splint use, and does this effect final ulnohumeral motion outcomes?"

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2009-09
• Study Completion: 2010-09
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Results First Submitted: 2012-04-16
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-30
• Last Update Submitted: 2012-05-30
• Results First Posted: 2012-07-03
• Last Update Posted: 2012-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• All adult patients with post-traumatic elbow contractures in the Hand and Upper Extremity Service at Massachusetts General Hospital are eligible to for enrollment in this study regardless of sex, race or ethnicity.

Exclusion Criteria

• Only English speaking patients will be eligible for the study since questionnaires have not been validated in other languages.

  • Vulnerable populations will not be recruited.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Static-progressive splint	Static-Progressive Splint	-
Dynamic Splint	Dynamic Splint	-

Primary Outcome Measures

Name	Time	Method
Change in Arc of Flexion and Extension	baseline and 6 months	Active ulnohumeral motion will be measured using a hand-held goniometer by the co-investigator not involved in the care of the patient at enrollment and 6 months after enrollment.

Secondary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire	12 months	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States