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

NCT01241916 | Completed Results DMC

• 1 other identifier: 2003P001441
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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?"

Conditions

Post-traumatic Stiff Elbows

Keywords

elbow, splint

Outcome Measures

Primary Outcomes (1)

• Change in Arc of Flexion and Extension

  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.

  baseline and 6 months

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

Static-progressive splint

EXPERIMENTAL

Device: Static-Progressive Splint

Dynamic Splint

EXPERIMENTAL

Device: Dynamic Splint

Interventions

Static-Progressive Splint DEVICE

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.

Static-progressive splint

Dynamic Splint DEVICE

Dynamic splints are a popular alternative, and apply a constant prolonged force to the tissues as additional motion is achieved.

Dynamic Splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Limitations and Caveats

Evaluation of \<80% of enrolled patients at planned follow-up times; musculoskeletal injury patients are difficult to maintain in protocol. Some violations where enrollment/evaluation points were slightly outside the planned range of acceptable times.

Results Point of Contact

• Title: Dr. David Ring
• Organization: Massachusetts General Hospital

dring@partners.org

617-724-3953

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: Director of Research, Hand Service

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: August 1, 2003
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2010
• Last Updated: July 3, 2012
• Results First Posted: July 3, 2012

Record last verified: 2012-05

Locations

US (1)