Comparing weightbearing methods after knee ligament surgery
Non-Weight Bearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Multiple Knee Ligament Reconstruction: a Randomized Controlled Trial
NA · Twin Cities Orthopedics · NCT05073276
This study tests whether resting the knee completely or allowing some weight on it after ligament surgery helps patients recover just as well.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 14 Years to 59 Years |
| Sex | All |
| Sponsor | Twin Cities Orthopedics (other) |
| Locations | 1 site (Edina, Minnesota) |
| Trial ID | NCT05073276 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of two rehabilitation protocols for patients undergoing knee ligament reconstruction. Participants will be randomly assigned to either a non-weightbearing or partial weightbearing regimen for the first six weeks post-surgery. The study aims to assess clinical equivalence in knee stability and other recovery metrics between the two groups. The use of specialized braces will help protect the knee during the recovery process.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 to 60 who are undergoing reconstruction of the posterior cruciate ligament, medial collateral ligament, or multiple knee ligaments.
Not a fit: Patients over 60 years old, those with previous knee surgeries, or concurrent injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation protocols that enhance recovery outcomes for knee ligament surgery patients.
How similar studies have performed: While the standard of care is currently non-weightbearing, this approach of comparing weightbearing methods is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 14 years old, \<60 * Reconstruction of PCL alone * Reconstruction of MCL alone * Reconstruction of combined multiligament injuries (PCL+ (FCL, PLC, ACL, MCL)) * Reconstruction of multiligament injuries (ACL+MCL) * 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 years old * Pregnant * Revision PCL reconstructions * Previous or concurrent vascular injury (vascular bypass procedure) * Associated fractures requiring concurrent surgery * Concurrent meniscal root or radial repair surgery
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 McGaver
- 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.
Conditions: Knee Injuries, anterior cruciate ligament, Multiple Knee Ligament Reconstruction