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.
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery: 1. non-weightbearing 2. 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 1. 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. 2. 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. 3. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
Patient is randomized to the weightbearing group the day after surgery.
Twin Cities Orthopedics
Edina, Minnesota, United States
RECRUITINGGapping (mm) measured on Standard of Care Varus stress radiographs
stress radiographs
Time frame: Pre-operative
Gapping (mm) measured on Standard of Care Varus stress radiographs
stress radiographs
Time frame: 6 months post-surgery
Numeric Pain Scale (NPS) (0-10 rating)
Pain scale 0-100
Time frame: Baseline and 6 months
Measurements by physical therapists (Edema, thigh circumference)
Measurements with tape
Time frame: 4,7, and 10 months after surgery
Measurements by physical therapists (range of motion)
Measurements with goniometer
Time frame: 4,7, and 10 months after surgery
Measurements by physical therapists (Quadriceps strength, gait analysis)
Measurements by biomechanics lab
Time frame: 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
Time frame: Baseline, 3 months, 6 months, 1 year
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