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| ID | Type | Description | Link |
|---|---|---|---|
| OGCA Contract #200497 | Other Identifier | UAB Link Number |
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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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The purpose of this project is to evaluate the effect of the Compassâ„¢ Universal Hinge external fixator on the outcome of patients following acute dislocation of the knee
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A External Brace | Active Comparator | Group A will have a non-invasive range of motion external brace placed following surgery |
|
| Group B Compass Knee Hinge | Experimental | Group B will have a Compass Knee Hinge placed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Volgas, MD | The University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham, Orthopaedic Trauma | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12861201 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A External Brace | Group A will have a non-invasive range of motion external brace placed following surgery |
| FG001 | Group B Compass Knee Hinge | Group B will have a Compass Knee Hinge placed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A External Brace | Group A will have a non-invasive range of motion external brace placed following surgery |
| BG001 | Group B Compass Knee Hinge | Group B will have a Compass Knee Hinge placed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 12 months |
|
Baseline to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A External Brace | Group A will have a non-invasive range of motion external brace placed following surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taylor Vlack, RN | University of Alabama at Birmingham | 205-996-6781 | tmwebb@uabmc.edu |
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| ID | Term |
|---|---|
| D031221 | Knee Dislocation |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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|
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| 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. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Group B Compass Knee Hinge | Group B will have a Compass Knee Hinge placed | 0 | 55 | 0 | 55 | 0 | 55 |
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| D007718 |
| Knee Injuries |
| D007869 | Leg Injuries |