Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05073276

Non- Vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction

Non-Weight Bearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Multiple Knee Ligament Reconstruction: a Randomized Controlled Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Twin Cities Orthopedics · Academic / Other
Sex
All
Age
14 Years – 59 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery: 1. non-weightbearing 2. partial weightbearing 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 1. Primary Aim: To determine if there is clinical equivalence in millimeters of posterior tibial translation on posterior stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation. 2. Primary Aim: To determine if there is clinical equivalence in millimeters of valgus and/or varus compartment gapping on stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation. 3. Secondary Aim: To determine if there is a difference in pain, edema, range of motion, gait, and quadriceps strength between groups. The current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing for the first six weeks after surgery.

Conditions

Interventions

TypeNameDescription
OTHERPhysical TherapyPatient is randomized to the weightbearing group the day after surgery.

Timeline

Start date
2020-01-01
Primary completion
2026-01-01
Completion
2026-01-01
First posted
2021-10-11
Last updated
2024-11-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05073276. Inclusion in this directory is not an endorsement.