Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Compass Hinge Stabilization of Knee Dislocations: A Randomized Trial (CKH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00582517
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : November 25, 2013
Last Update Posted : June 5, 2017
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Steven Theiss, MD, University of Alabama at Birmingham

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Knee Dislocation Device: Compass Universal Hinge External Fixator Procedure: Non-invasive External Knee Brace Not Applicable

Detailed Description:

Prospective randomized outcome study. Patients will be randomized either into the control group (Group A) or the study group (Group B) based on a computer generated randomization table. Both groups will undergo an identical surgical protocol, as outlined below. The only difference is that patients in Group A will have a range of motion external brace placed following surgery, while patients in Group B will have a CKH placed. The rehabilitation protocol for the two groups will be identical, as outlined below. Both groups will undergo an Anterior Cruciate Ligament (ACL) reconstruction on a delayed basis two months following surgery, if the ACL was torn during the knee dislocation. The ACL reconstruction will be delayed in both groups if a minimum range of motion of 10-90 degrees has not been attained.

Surgical Protocol : Approximately 10 - 21 days following the injury, patients will undergo the first surgical procedure on their knee dislocation. During the first procedure, they will have a Posterior Cruciate Ligament (PCL) reconstruction using an achilles tendon allograft, with the direct onlay, two bundle technique. Additionally, any damage to either the posterior medial or posterior lateral corner will be repaired (not reconstructed), and any meniscus pathology will be addressed. The final step of this first procedure will be applying the CKH to patients randomized to the compass group (the alignment pins will be placed prior to repair of the corner). Patients will undergo an ACL reconstruction (if necessary) approximately 8 weeks following the initial surgery, when the CKH will be removed. Additional surgeries will be performed on patients to treat motion problems/arthrofibrosis as well as recurrent instability on an "as-needed basis."

Rehabilitation Protocol - aggressive rehabilitation will be started on the day following surgery. Patients will be placed in Continuous Passive Motion (CPM) machines with an initial range of motion of 0 - 30 degrees. The hinge will be locked into full extension for at least 4 hours per day. We will continue CPM for two weeks, with a goal of increasing by at least 10 degrees per day to 90 degrees of flexion. Weightbearing will be allowed as tolerated with the hinge locked in extension.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compass Hinge Stabilization of Knee Dislocations: A Randomized Trial
Study Start Date : August 2000
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Group A External Brace
Group A will have a non-invasive range of motion external brace placed following surgery
 Procedure: Non-invasive External Knee Brace
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.
Experimental: Group B Compass Knee Hinge
Group B will have a Compass Knee Hinge placed
 Device: Compass Universal Hinge External Fixator
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.
Other Name: Compass Knee Hinge


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Knee Stability [ Time Frame: 12 months ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582517


Locations
Layout table for location information
United States, Alabama
The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Smith & Nephew, Inc.
Investigators
Layout table for investigator information
Principal Investigator: David A Volgas, MD The University of Alabama at Birmingham
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Steven Theiss, MD, Study Coordinator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00582517    
Other Study ID Numbers: F000330008
OGCA Contract #200497 ( Other Identifier: UAB Link Number )
First Posted: December 28, 2007    Key Record Dates
Results First Posted: November 25, 2013
Last Update Posted: June 5, 2017
Last Verified: June 2017
Keywords provided by Steven Theiss, MD, University of Alabama at Birmingham:
Orthopaedic Trauma
Knee Dislocation
Compass Hinge External Fixator
External Brace
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Dislocations
Knee Dislocation
Joint Diseases
Musculoskeletal Diseases
 Wounds and Injuries
Knee Injuries
Leg Injuries