Non- vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073276
• Other study ID #: RFL_NWB vs PWB-Multi-Knee Lig
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 2026

Study information

• Verified date: April 2023
• Source: Twin Cities Orthopedics
• Contact: Becky McGaver
• Phone: 952-456-7136
• Email: research[@]tcomn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Other:
• Physical Therapy
Patient is randomized to the weightbearing group the day after surgery.

Locations

Country	Name	City	State
United States	Twin Cities Orthopedics	Edina	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Twin Cities Orthopedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gapping (mm) measured on Standard of Care Varus stress radiographs	stress radiographs	Pre-operative
Primary	Gapping (mm) measured on Standard of Care Varus stress radiographs	stress radiographs	6 months post-surgery
Secondary	Numeric Pain Scale (NPS) (0-10 rating)	Pain scale 0-100	Baseline and 6 months
Secondary	Measurements by physical therapists (Edema, thigh circumference)	Measurements with tape	4,7, and 10 months after surgery
Secondary	Measurements by physical therapists (range of motion)	Measurements with goniometer	4,7, and 10 months after surgery
Secondary	Measurements by physical therapists (Quadriceps strength, gait analysis)	Measurements by biomechanics lab	4,7, and 10 months after surgery
Secondary	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