Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction

Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: a Randomized Controlled Trial

This is a prospective randomized controlled trial with the purpose to determine if patients undergoing fibular collateral ligament (FCL) reconstruction alone or combined FCL and anterior cruciate ligament (ACL) reconstructions can safely begin full 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. partial weightbearing
2. full controlled weightbearing

An immobilizer brace in extension will be used from post-operative day 0 through 13 and a CTi ligament knee brace (Össur Americas, Foothill Ranch, California) will be used from 14 to 42 days post-surgery to protect against side-to-side motion while weight bearing.

Specific Aims

1. Primary Aim: To determine if there is a difference in millimeters of varus gapping on anteroposterior (AP) stress radiographs at six months post-surgery between patients who are partial weight bearing versus full controlled weight bearing during the first six weeks of post-surgical rehabilitation. This distance will be compared to varus gapping measured on the contralateral uninjured control knee.
2. Secondary Aim: To determine if there is a difference in pain, edema, and range of motion, gait, quadriceps strength, and patient reported outcomes between groups.

The Investigators hypothesize that there will be no clinically significant difference (< 2 mm change) in varus gapping between the control and treatment groups. Results of this study will help to expedite return to pre-injury levels of activity and decrease adverse sequelae associated with non-weight bearing such as osteopenia, muscle atrophy, loss of ankle range of motion, and increased risk of deep vein thrombosis.

The current standard of care for FCL reconstruction is early controlled partial weight -bearing for the first six weeks after surgery.

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

Contacts and Locations

• Study Contact: Name: Becky Stone; Phone Number: 952-456-7136; Email: research@tcomn.com
• Study Contact Backup: Name: Kayla Seiffert; Phone Number: 952-456-7085; 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 FCL alone
• Combined FCL + ACL reconstructions
• 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
• Pregnant
• Revision FCL reconstructions
• Concurrent biceps femoris or lateral capsular repairs
• Concurrent PCL or MCL reconstructions
• Concomitant meniscus root or radial repair surgery with transtibial technique

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: 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.
Experimental: Full weight -bearing for the first six weeks after surgery; If the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities.	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 radiograph	Pre-operative
Gapping (mm) measured Standard of Care Varus stress radiographs	stress radiograph	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 (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

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 14, 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: fibular collateral ligament (FCL); anterior cruciate ligament (ACL)
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: RFL_FWB vs PWB-FCL

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