Knee Injuries
Conditions
Keywords
fibular collateral ligament (FCL), anterior cruciate ligament (ACL)
Brief summary
This is a prospective randomized controlled trial with the purpose to determine if patients undergoing fibular collateral ligament (FCL) reconstruction alone or combined FCL and anterior cruciate ligament (ACL) reconstructions can safely begin full controlled weightbearing for the first six weeks after surgery.
Detailed description
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery: 1. partial weightbearing 2. full controlled weightbearing An immobilizer brace in extension will be used from post-operative day 0 through 13 and a CTi ligament knee brace (Össur Americas, Foothill Ranch, California) will be used from 14 to 42 days post-surgery to protect against side-to-side motion while weight bearing. Specific Aims 1. Primary Aim: To determine if there is a difference in millimeters of varus gapping on anteroposterior (AP) stress radiographs at six months post-surgery between patients who are partial weight bearing versus full controlled weight bearing during the first six weeks of post-surgical rehabilitation. This distance will be compared to varus gapping measured on the contralateral uninjured control knee. 2. Secondary Aim: To determine if there is a difference in pain, edema, and range of motion, gait, quadriceps strength, and patient reported outcomes between groups. The Investigators hypothesize that there will be no clinically significant difference (\< 2 mm change) in varus gapping between the control and treatment groups. Results of this study will help to expedite return to pre-injury levels of activity and decrease adverse sequelae associated with non-weight bearing such as osteopenia, muscle atrophy, loss of ankle range of motion, and increased risk of deep vein thrombosis. The current standard of care for FCL reconstruction is early controlled partial weight -bearing for the first six weeks after surgery.
Interventions
OTHERPhysical Therapy
Patient is randomized to the weightbearing group the day after surgery.
Sponsors
Twin Cities Orthopedics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* ≥ 14 years old, \<60 * Reconstruction of FCL alone * Combined FCL + ACL reconstructions * Males or females * Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
Exclusion criteria
* \< 14 years old, \> 60 * Pregnant * Revision FCL reconstructions * Concurrent biceps femoris or lateral capsular repairs * Concurrent PCL or MCL reconstructions * Concomitant meniscus root or radial repair surgery with transtibial technique
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gapping (mm) measured on Standard of Care Varus stress radiographs | Pre-operative | stress radiograph |
| Gapping (mm) measured Standard of Care Varus stress radiographs | 6 months post-surgery | stress radiograph |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurements by physical therapists (Range of Motion) | 4,7, and 10 months after surgery | Measurements with goniometer |
| Numeric Pain Scale (NPS) (0-10 rating) | Baseline and 6 months | Pain scale 0-100 |
| Patient reported outcome scores | Baseline, 3 months, 6 months, 1 year | Surveys: International Knee Documentation Committee (IKDC), Cincinnati Knee Rating System (Cincinnati), Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner, Lysholm Knee Scoring Scale (Lysholm), and Veterans Rand 12 (VR-12) or Short Form-12 (SF-12) General Health Survey, lower extremity functional scale, Sports Medicine Questionnaire and survey/patient satisfaction |
| Measurements by physical therapists (Quadriceps strength, gait analysis) | 4,7, and 10 months after surgery | Measurements by biomechanics lab |
| Measurements by physical therapists (Edema, thigh circumference) | 4,7, and 10 months after surgery | Measurements with tape |
Countries
United States
Contacts
Primary ContactBecky Stone
Backup ContactKayla Seiffert
Outcome results
None listed