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

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073263
• Other study ID #: RFL_FWB vs PWB-FCL
• 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 Stone
• 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 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.

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.

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 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

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 radiograph	Pre-operative
Primary	Gapping (mm) measured Standard of Care Varus stress radiographs	stress radiograph	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