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| Sponsors and Collaborators: |
University of Alabama at Birmingham Smith & Nephew, Inc. |
| Information provided by: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00582517 |
Purpose
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 | Intervention |
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Knee Dislocation |
Device: Compass Universal Hinge External Fixator Procedure: Non-invasive External Knee Brace |
| MedlinePlus related topics: | Dislocations Injuries Wounds |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Compass Hinge Stabilization of Knee Dislocations: A Randomized Trial |
| Enrollment: | 100 |
| Study Start Date: | August 2000 |
| Estimated Study Completion Date: | August 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1, A: Active Comparator
Group A will have a non-invasive range of motion external brace placed following surgery
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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.
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2, B: Experimental
Group B will have a Compass Knee Hinge placed
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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.
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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 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 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.
Eligibility
| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |||||
| The University of Alabama at Birmingham, Orthopaedic Trauma | |||||
| Birmingham, Alabama, United States, 35294 | |||||
| University of Alabama at Birmingham |
| Smith & Nephew, Inc. |
| Principal Investigator: | James P Stannard, MD | The University of Alabama at Birmingham |
More Information
| Responsible Party: | The University of Alabama at Birmingham ( James P. Stannard, MD, Professor of Surgery, Assoc. Director of Orthopaedic Surgery ) |
| Study ID Numbers: | F000330008, OGCA Contract #200497 |
| First Received: | December 18, 2007 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00582517 |
| Health Authority: | United States: Institutional Review Board |
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