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

November 15, 2010
May 30, 2012
August 2003
September 2009   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01241916 on ClinicalTrials.gov Archive Site
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.
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?"
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A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness
A Prospective Randomized Trial of Static-Progressive Versus Dynamic Splinting for Post-Traumatic Elbow Stiffness

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?"

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Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Post-traumatic Stiff Elbows
  • 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.
  • Experimental: Static-progressive splint
    Intervention: Device: Static-Progressive Splint
  • Experimental: Dynamic Splint
    Intervention: Device: Dynamic Splint
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
September 2010
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01241916
2003P001441
Yes
David C. Ring, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Not Provided
Massachusetts General Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP