Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical Therapy.
- Who it may be relevant to
- Registry conditions: Knee Injuries. Basic parameters: 14 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: a Randomized Controlled Trial
Overview
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:
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.
Interventions
- Other Physical Therapy
Patient is randomized to the weightbearing group the day after surgery.
Primary outcome measures
- Gapping (mm) measured on Standard of Care Varus stress radiographs [Time frame: Pre-operative]
- Gapping (mm) measured Standard of Care Varus stress radiographs [Time frame: 6 months post-surgery]
Secondary outcome measures (5)
- Numeric Pain Scale (NPS) (0-10 rating) [Time frame: Baseline and 6 months]
- Measurements by physical therapists (Edema, thigh circumference) [Time frame: 4,7, and 10 months after surgery]
- Measurements by physical therapists (Range of Motion) [Time frame: 4,7, and 10 months after surgery]
- Measurements by physical therapists (Quadriceps strength, gait analysis) [Time frame: 4,7, and 10 months after surgery]
- Patient reported outcome scores [Time frame: Baseline, 3 months, 6 months, 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Twin Cities Orthopedics — Edina
Identifiers
NCT: NCT05073263 · RFL_FWB vs PWB-FCL