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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-weightbearing for the first six weeks after surgery | Active Comparator | Not weightbearing after surgery |
|
| Partial weight -bearing for the first six weeks after surgery | Experimental | Partial weightbearing will be defined as 40% of the patient's body weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy | Other | Patient is randomized to the weightbearing group the day after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gapping (mm) measured on Standard of Care Varus stress radiographs | stress radiographs | Pre-operative |
| Gapping (mm) measured on Standard of Care Varus stress radiographs | stress radiographs | 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Scale (NPS) (0-10 rating) | Pain scale 0-100 | Baseline and 6 months |
| Measurements by physical therapists (Edema, thigh circumference) | Measurements with tape |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Becky McGaver | Contact | 952-456-7136 | research@tcomn.com | |
| Kayla Seiffert | Contact | 952-456-7085 | research@tcomn.com |
| Name | Affiliation | Role |
|---|---|---|
| Robert F LaPrade, MD, PhD | Twin Cities Orthopedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Twin Cities Orthopedics | Recruiting | Edina | Minnesota | 55435 | United States |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| 4,7, and 10 months after surgery |
| Measurements by physical therapists (range of motion) | Measurements with goniometer | 4,7, and 10 months after surgery |
| Measurements by physical therapists (Quadriceps strength, gait analysis) | Measurements by biomechanics lab | 4,7, and 10 months after surgery |
| Patient reported outcome scores | 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 | Baseline, 3 months, 6 months, 1 year |