Non- Vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction

Not Applicable

Recruiting

• Conditions: Knee Injuries
• Interventions: Other: Physical Therapy

• Registration Number: NCT05073276
• Lead Sponsor: Twin Cities Orthopedics

Brief 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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-weightbearing for the first six weeks after surgery	Physical Therapy	Not weightbearing after surgery
Partial weight -bearing for the first six weeks after surgery	Physical Therapy	Partial weightbearing will be defined as 40% of the patient's body weight.

Primary Outcome Measures

Name	Time	Method
Gapping (mm) measured on Standard of Care Varus stress radiographs	6 months post-surgery	stress radiographs

Secondary Outcome Measures

Name	Time	Method
Measurements by physical therapists (range of motion)	4,7, and 10 months after surgery	Measurements with goniometer
Numeric Pain Scale (NPS) (0-10 rating)	Baseline and 6 months	Pain scale 0-100
Measurements by physical therapists (Edema, thigh circumference)	4,7, and 10 months after surgery	Measurements with tape
Measurements by physical therapists (Quadriceps strength, gait analysis)	4,7, and 10 months after surgery	Measurements by biomechanics lab
Patient reported outcome scores	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

Trial Locations

Locations (1)

Twin Cities Orthopedics; 🇺🇸 Edina, Minnesota, United States