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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

David C. Ring, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01241916

First received: November 15, 2010

Last updated: May 30, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 15, 2010
Last Updated Date	May 30, 2012
Start Date ^ICMJE	August 2003
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 30, 2012)	Change in Arc of Flexion and Extension [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE (submitted: November 15, 2010)	gains in motion [ Time Frame: 12 months ] [ Designated as safety issue: No ] Active ulnohumeral motion will be measured using a hand-held goniometer by the coinvestigator not involved in the care of the patient at the routine office visits at 2 months, 4 months, and 6 months after enrollment. The DASH questionnaire will be completed six months and 12 months after enrollment. Radiographs and other diagnostic studies will be obtained at the discretion of the treating surgeon and will not differ from routine clinical care.
Change History	Complete list of historical versions of study NCT01241916 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 30, 2012)	Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE (submitted: November 15, 2010)	patient compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ] "Is there a significant difference in patient compliance with static progressive versus dynamic splint use, and does this effect final ulnohumeral motion outcomes?"
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness
Official Title ^ICMJE	A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Post-traumatic Stiff Elbows
Intervention ^ICMJE	Device: Static-Progressive Splint Static progressive splinting is a well-established adjunct for restoring elbow motion. Such splints apply a static stress relaxation force to the elbow tissues, which is sequentially increased, as motion is achieved. Device: Dynamic Splint Dynamic splints are a popular alternative, and apply a constant prolonged force to the tissues as additional motion is achieved.
Study Arm (s)	Experimental: Static-progressive splint Intervention: Device: Static-Progressive Splint Experimental: Dynamic Splint Intervention: Device: Dynamic Splint
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	66
Completion Date	September 2010
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01241916
Other Study ID Numbers ^ICMJE	2003P001441
Has Data Monitoring Committee	Yes
Responsible Party	David C. Ring, MD, Massachusetts General Hospital
Study Sponsor ^ICMJE	Massachusetts General Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Massachusetts General Hospital
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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