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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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 radiograph
Time frame: Pre-operative
Gapping (mm) measured Standard of Care Varus stress radiographs
stress radiograph
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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