Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction

Study Overview
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Brief Summary
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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
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Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery: partial weightbearing 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 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. 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.

Official Title
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Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: A Randomized Controlled Trial

Conditions
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Knee Injuries

Intervention / Treatment
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* Other: Physical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Partial weight -bearing for the first six weeks after surgery<br>Partial weightbearing will be defined as 40% of the patient's body weight. | Other: Physical Therapy<br>* Patient is randomized to the weightbearing group the day after surgery.<br>|
| Experimental: Full weight -bearing for the first six weeks after surgery<br>If the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities. | Other: Physical Therapy<br>* Patient is randomized to the weightbearing group the day after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gapping (mm) measured on Standard of Care Varus stress radiographs | stress radiograph | Pre-operative | 
| Gapping (mm) measured Standard of Care Varus stress radiographs | stress radiograph | 6 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Scale (NPS) (0-10 rating) | Pain scale 0-100 | Baseline and 6 months | 
| Measurements by physical therapists (Edema, thigh circumference) | Measurements with tape | 4,7, and 10 months after surgery | 
| Measurements by physical therapists (Range of Motion) | Measurements with goniometer | 4,7, and 10 months after surgery | 
| Measurements by physical therapists (Quadriceps strength, gait analysis) | Measurements by biomechanics lab | 4,7, and 10 months after surgery | 
| Patient reported outcome scores | 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 | Baseline, 3 months, 6 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibular collateral ligament (FCL), anterior cruciate ligament (ACL)