Non- vs Partial Controlled Weightbearing After Multiple Knee 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 isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL), posterolateral corner (PLC), and MCL reconstructions (or any combination of multiple ligaments) can safely begin partial 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: non-weightbearing partial weightbearing An immobilizer brace in extension will be used from post-operative day 0 through 4 and a dynamic stabilizing posterior knee brace (Ossur) will be used from 5 days through 6 months post-surgery to protect against increased posterior translation forces due to gravity and while weightbearing for patients with PCL reconstructions. Specific Aims Primary Aim: To determine if there is clinical equivalence in millimeters of posterior tibial translation on posterior stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation. Primary Aim: To determine if there is clinical equivalence in millimeters of valgus and/or varus compartment gapping on stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation. Secondary Aim: To determine if there is a difference in pain, edema, range of motion, gait, and quadriceps strength between groups. The current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing for the first six weeks after surgery.

Official Title
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Non-Weight Bearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Multiple Knee Ligament Reconstruction: 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 PCL alone Reconstruction of MCL alone Reconstruction of combined multiligament injuries (PCL+ (FCL, PLC, ACL, MCL)) Reconstruction of multiligament injuries (ACL+MCL) 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 years old Pregnant Revision PCL reconstructions Previous or concurrent vascular injury (vascular bypass procedure) Associated fractures requiring concurrent surgery Concurrent meniscal root or radial repair surgery

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: Non-weightbearing for the first six weeks after surgery<br>Not weightbearing after surgery | Other: Physical Therapy<br>* Patient is randomized to the weightbearing group the day after surgery.<br>|
| Experimental: 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>|

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 radiographs | Pre-operative | 
| Gapping (mm) measured on Standard of Care Varus stress radiographs | stress radiographs | 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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anterior cruciate ligament (ACL), Multiple Knee Ligament Reconstruction