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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Injuries
• Intervention / Treatment: Other: Physical Therapy

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kayla Seiffert; Phone Number: 952-456-7085; Email: research@tcomn.com
• Study Contact Backup: Name: Becky McGaver; Phone Number: 952-456-7136; Email: research@tcomn.com

Study Locations

• United States
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Recruiting
      • Twin Cities Orthopedics
      • Contact: Becky Stone; Phone Number: 952-456-7136; Email: research@tcomn.com
      • Contact: Robert F LaPrade, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 59 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-weightbearing for the first six weeks after surgery; Not weightbearing after surgery	Other: Physical Therapy; Patient is randomized to the weightbearing group the day after surgery.
Experimental: Partial weight -bearing for the first six weeks after surgery; Partial weightbearing will be defined as 40% of the patient's body weight.	Other: Physical Therapy; Patient is randomized to the weightbearing group the day after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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
Measurements by physical therapists (range of motion)	Measurements with goniometer	4,7, and 10 months after surgery

Collaborators and Investigators

• Sponsor: Twin Cities Orthopedics
• Investigators: Principal Investigator: Robert F LaPrade, MD, PhD, Twin Cities Orthopedics

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: anterior cruciate ligament (ACL); Multiple Knee Ligament Reconstruction
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: RFL_NWB vs PWB-Multi-Knee Lig

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No