Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Twin Cities Orthopedics
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Gapping (mm) measured Standard of Care Varus stress radiographs
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 59 Years (Child, Adult)
- Sex
- All
- Accepts 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
- •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
Outcomes
Primary Outcomes
Gapping (mm) measured Standard of Care Varus stress radiographs
Time Frame: 6 months post-surgery
stress radiograph
Gapping (mm) measured on Standard of Care Varus stress radiographs
Time Frame: Pre-operative
stress radiograph
Secondary Outcomes
- Numeric Pain Scale (NPS) (0-10 rating)(Baseline and 6 months)
- Measurements by physical therapists (Range of Motion)(4,7, and 10 months after surgery)
- Patient reported outcome scores(Baseline, 3 months, 6 months, 1 year)
- Measurements by physical therapists (Edema, thigh circumference)(4,7, and 10 months after surgery)
- Measurements by physical therapists (Quadriceps strength, gait analysis)(4,7, and 10 months after surgery)