Twin Cities Orthopedics
Edina, Minnesota, 55435, United States
Location status: Recruiting
NCT Number: NCT05073276
This is a prospective randomized controlled trial with the purpose to determine if patients undergoing isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL), posterolateral corner (PLC), and MCL reconstructions (or any combination of multiple ligaments) can safely begin partial controlled weightbearing for the first six weeks after surgery.
Interested in participating?
Request Info14 year–59 year
All sexes
Interventional
Not applicable
Edina, Minnesota, 55435, United States
Location status: Recruiting
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:
An immobilizer brace in extension will be used from post-operative day 0 through 4 and a dynamic stabilizing posterior knee brace (Ossur) will be used from 5 days through 6 months post-surgery to protect against increased posterior translation forces due to gravity and while weightbearing for patients with PCL reconstructions.
Specific Aims
The current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing for the first six weeks after surgery.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient is randomized to the weightbearing group the day after surgery.
Time frame: Pre-operative
stress radiographs
Time frame: 6 months post-surgery
stress radiographs
Time frame: Baseline and 6 months
Pain scale 0-100
Time frame: 4,7, and 10 months after surgery
Measurements with tape
Time frame: 4,7, and 10 months after surgery
Measurements with goniometer
Time frame: 4,7, and 10 months after surgery
Measurements by biomechanics lab
Time frame: Baseline, 3 months, 6 months, 1 year
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
Contact information is provided by the study sponsor or research team.
Becky McGaver
CONTACT
Kayla Seiffert
CONTACT
Twin Cities Orthopedics
Other
Non-Weight Bearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Multiple Knee Ligament Reconstruction: a Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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