Knee Dislocation
Conditions
Keywords
Orthopaedic Trauma, Knee Dislocation, Compass Hinge External Fixator, External Brace
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
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.
Interventions
DEVICECompass 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.
PROCEDURENon-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.
Sponsors
Smith & Nephew, Inc.
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Stability | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A External Brace Group A will have a non-invasive range of motion external brace placed following surgery | 45 |
| Group B Compass Knee Hinge Group B will have a Compass Knee Hinge placed | 55 |
| Total | 100 |
Baseline characteristics
| Characteristic | Group A External Brace | Group B Compass Knee Hinge | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 52 Participants | 97 Participants |
| Region of Enrollment United States | 45 participants | 55 participants | 100 participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 24 Participants |
| Sex: Female, Male Male | 37 Participants | 39 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 55 |
| other Total, other adverse events | 0 / 45 | 0 / 55 |
| serious Total, serious adverse events | 0 / 45 | 0 / 55 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A External Brace | Knee Stability | Unstable at 30 degree plane | 12 participants |
| Group A External Brace | Knee Stability | Unstable at 70 degree plane | 14 participants |
| Group A External Brace | Knee Stability | Stable at 70 degree plane | 27 participants |
| Group A External Brace | Knee Stability | Stable at 90 degree plane | 4 participants |
| Group A External Brace | Knee Stability | Stable at 30 degree plane | 29 participants |
| Group B Compass Knee Hinge | Knee Stability | Stable at 90 degree plane | 12 participants |
| Group B Compass Knee Hinge | Knee Stability | Stable at 30 degree plane | 26 participants |
| Group B Compass Knee Hinge | Knee Stability | Unstable at 30 degree plane | 17 participants |
| Group B Compass Knee Hinge | Knee Stability | Stable at 70 degree plane | 30 participants |
| Group B Compass Knee Hinge | Knee Stability | Unstable at 70 degree plane | 13 participants |