Comparing full and partial weightbearing after fibular collateral ligament surgery
Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: a Randomized Controlled Trial
This study is testing whether putting full weight on your leg or just partial weight after fibular ligament surgery helps patients recover better during the first six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 14 Years to 59 Years |
| Sex | All |
| Sponsor | Twin Cities Orthopedics Academic / other |
| Locations | 1 site (Edina, Minnesota) |
| Trial ID | NCT05073263 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective randomized controlled trial aimed at determining the safety and efficacy of full controlled weightbearing versus partial weightbearing during the first six weeks of rehabilitation following fibular collateral ligament (FCL) reconstruction. Patients will be randomly assigned to one of the two rehabilitation protocols and will be monitored for differences in varus gapping on stress radiographs, as well as pain, edema, range of motion, gait, quadriceps strength, and patient-reported outcomes. An immobilizer brace will be used initially, followed by a CTi ligament knee brace to protect the knee during the rehabilitation period.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 14 to 60 who are undergoing FCL reconstruction, either alone or in combination with ACL reconstruction.
Not a fit: Patients over 60 years old, those with concurrent knee surgeries, or those requiring revision surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation protocols that expedite recovery and enhance patient outcomes after knee surgery.
How similar studies have performed: While the approach of comparing weightbearing protocols is common, the specific focus on FCL reconstruction and the associated outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edina, Minnesota
- Twin Cities Orthopedics — Edina, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Robert F LaPrade, MD, PhD — Twin Cities Orthopedics
- Study coordinator: Becky Stone
- Email: research@tcomn.com
- Phone: 952-456-7136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.