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Progressive Splinting Status Post Elbow Fractures and Dislocations (JAS)

Primary Purpose

Upper Extremity Fracture, Upper Extremity Dislocation, Fractures, Comminuted

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
JAS Brace
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Upper Extremity Fracture focused on measuring Elbow, Upper Extremity Fractures, Distal Humerus, Elbow Injuries, Dislocations, Peri-articular Elbow Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Extra or intraarticular distal humerus or elbow fracture or fracture/dislocation
  • Agrees to participate and signs informed consent
  • English Speaking (outcome questionnaires are validated for English only)

Exclusion Criteria:

  • Less than 18 years of age
  • Closed Head Injury
  • Burn Injuries
  • Ipsilateral upper extremity fracture(s) requiring surgery
  • Nonunion of prior distal humerus fracture or fracture dislocation
  • Type 3 open distal humerus fracture dislocation
  • Insufficient fracture fixation to allow early range of motion
  • Transient population with no fixed address
  • Not willing to sign informed consent
  • Does not speak English

Sites / Locations

  • Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Joint Active Systems Brace (JAS Brace)

PT Only Group

Arm Description

Elbow is placed in a brace to apply an extension force

No brace is used

Outcomes

Primary Outcome Measures

Elbow ROM at 12 Months
The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.

Secondary Outcome Measures

Disabilities of the Arm, Shoulder and Hand (DASH) Score
Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )

Full Information

First Posted
December 19, 2007
Last Updated
July 22, 2016
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00580866
Brief Title
Progressive Splinting Status Post Elbow Fractures and Dislocations
Acronym
JAS
Official Title
Multi-Center Controlled Trial of Static Progressive Splinting Status Post Elbow Fractures and Dislocations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function.
Detailed Description
Fractures and dislocations about the elbow are high energy injuries which are often comminuted and associated with extensive soft tissue damage and are very difficult to treat. The most problematic complication for these fractures is the potential development of a cosmetic defect and functional disability due to the loss of 20 degrees to 30 degrees of terminal extension of the elbow. It has been found imperative that early motion and physical therapy be implemented to help produce the best results in terms of a patient's range of motion and decreases secondary surgeries. We intend to examine a group of patients with distal humerus and elbow fracture/dislocations who use static stretching braces along with physical therapy (PT) within 3 weeks after surgery, in contrast to physical therapy treatment alone after surgery. The static stretching brace group will have a small electronic circuit attached to the brace that will record patient's usage. Improvement of patient's overall functional outcome will also be measured by a standard functional outcome instrument, the Disabilities of Arm, Shoulder and Hand (DASH) form. The DASH Form is a standard functional outcome instrument specific to upper extremity injuries. In addition, a more general measure, the Visual Analog Scale (VAS), will be used to assess pain. The use of the static motion brace may help eliminate the necessity of additional treatments, saving both pain and suffering, as well as monetary costs for the patient, while simultaneously producing a better long term functional and cosmetic outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Fracture, Upper Extremity Dislocation, Fractures, Comminuted, Elbow Fracture, Elbow Dislocation
Keywords
Elbow, Upper Extremity Fractures, Distal Humerus, Elbow Injuries, Dislocations, Peri-articular Elbow Injuries

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Joint Active Systems Brace (JAS Brace)
Arm Type
Experimental
Arm Description
Elbow is placed in a brace to apply an extension force
Arm Title
PT Only Group
Arm Type
No Intervention
Arm Description
No brace is used
Intervention Type
Device
Intervention Name(s)
JAS Brace
Other Intervention Name(s)
JAS Static Progressive Stretch, Joint Active Systems Brace (JAS Brace), Static Stretching Brace, Static Progressive Stretching Brace
Intervention Description
For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
Primary Outcome Measure Information:
Title
Elbow ROM at 12 Months
Description
The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.
Time Frame
2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively
Secondary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Description
Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )
Time Frame
12 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Extra or intraarticular distal humerus or elbow fracture or fracture/dislocation Agrees to participate and signs informed consent English Speaking (outcome questionnaires are validated for English only) Exclusion Criteria: Less than 18 years of age Closed Head Injury Burn Injuries Ipsilateral upper extremity fracture(s) requiring surgery Nonunion of prior distal humerus fracture or fracture dislocation Type 3 open distal humerus fracture dislocation Insufficient fracture fixation to allow early range of motion Transient population with no fixed address Not willing to sign informed consent Does not speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William T Obremskey, MD, MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-8774
Country
United States

12. IPD Sharing Statement

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Progressive Splinting Status Post Elbow Fractures and Dislocations

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