Compass Hinge Stabilization of Knee Dislocations: A Randomized Trial

NCT00582517 | Completed Results

• 2 other identifiers: F000330008OGCA Contract #200497
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to evaluate the effect of the Compass™ Universal Hinge external fixator on the outcome of patients following acute dislocation of the knee

Conditions

Knee Dislocation

Keywords

Orthopaedic Trauma; Knee Dislocation; Compass Hinge External Fixator; External Brace

Outcome Measures

Primary Outcomes (1)

• Knee Stability

  The hypothesis of this study was that there would be equivalent final knee range of motion with fewer failures for ligament reconstructions following knee dislocations that were supplemented with the Compass Knee Hinge as compared to a control group.

  12 months

Study Arms (2)

Group A External Brace

ACTIVE COMPARATOR

Group A will have a non-invasive range of motion external brace placed following surgery

Procedure: Non-invasive External Knee Brace

Group B Compass Knee Hinge

EXPERIMENTAL

Group B will have a Compass Knee Hinge placed

Device: Compass Universal Hinge External Fixator

Interventions

Compass Universal Hinge External Fixator DEVICE

Application of the Compass Knee Hinge adds approximately 30 minutes to the surgical time. After the apparatus has been in place for the appropriate amount of time (6-8 weeks), it is removed either in the clinical setting, or in the one-day surgery area of UAB Highlands.

Also known as: Compass Knee Hinge

Group B Compass Knee Hinge

Non-invasive External Knee Brace PROCEDURE

For Group A patients, an external knee brace (several brands available and no one brace specified for this study) will be placed on the leg following surgical repair of the knee dislocation.

Group A External Brace

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trauma patient with a knee dislocation that requires surgical repair
• Adult patient (19 years and older)

You may not qualify if:

• Patients unable or unwilling to comply with follow-up gait, radiographic and clinical evaluations necessary to complete the study
• Patients unable or unwilling to give informed consent and/or who have no responsible family member willing to give consent
• Pregnant women
• Prisoners

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Stannard JP, Sheils TM, McGwin G, Volgas DA, Alonso JE. Use of a hinged external knee fixator after surgery for knee dislocation. Arthroscopy. 2003 Jul-Aug;19(6):626-31. doi: 10.1016/s0749-8063(03)00125-7.

  PMID: 12861201 RESULT

MeSH Terms

Conditions

Knee Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Results Point of Contact

• Title: Taylor Vlack, RN
• Organization: University of Alabama at Birmingham

tmwebb@uabmc.edu

205-996-6781

Study Officials

• David A Volgas, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

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: Study Coordinator

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 28, 2007
• Study Start: August 1, 2000
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 5, 2017
• Results First Posted: November 25, 2013

Record last verified: 2017-06

Locations

US (1)