- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00582517
Compass Hinge Stabilization of Knee Dislocations: A Randomized Trial (CKH)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- The University of Alabama at Birmingham, Orthopaedic Trauma
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A External Brace
Group A will have a non-invasive range of motion external brace placed following surgery
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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.
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Experimental: Group B Compass Knee Hinge
Group B will have a Compass Knee Hinge placed
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Stability
Time Frame: 12 months
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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.
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12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David A Volgas, MD, The University of Alabama at Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F000330008
- OGCA Contract #200497 (Other Identifier: UAB Link Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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