Progressive Splinting Status Post Elbow Fractures and Dislocations

NCT00580866 | Terminated Results

• 1 other identifier: 051196
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively

Secondary Outcomes (1)

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

  12 months post-operatively

Study Arms (2)

Joint Active Systems Brace (JAS Brace)

EXPERIMENTAL

Elbow is placed in a brace to apply an extension force

Device: JAS Brace

PT Only Group

NO INTERVENTION

No brace is used

Interventions

JAS Brace DEVICE

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.

Also known as: JAS Static Progressive Stretch, Joint Active Systems Brace (JAS Brace), Static Stretching Brace, Static Progressive Stretching Brace

Joint Active Systems Brace (JAS Brace)

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8774, United States

Location

MeSH Terms

Conditions

Fractures, Comminuted; Elbow Fractures; Elbow Injuries; Joint Dislocations

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Arm Injuries; Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: William Obremskey
• Organization: Vanderbilt

william.obremskey@Vanderbilt.Edu

6159363630

Study Officials

• William T Obremskey, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 27, 2007
• Study Start: September 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 7, 2016
• Results First Posted: September 7, 2016

Record last verified: 2016-07

Locations

US (1)