Actively Recruiting

Phase Not Applicable
Age: 14Years - 59Years
All Genders
Healthy Volunteers
ID05073263

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

Led by Twin Cities Orthopedics · Updated on 2024-11-22

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to find out if patients who have surgery to rebuild the fibular collateral ligament (FCL) alone or together with the anterior cruciate ligament (ACL) can safely start full controlled weightbearing during the first six weeks after surgery. The study compares two different rehabilitation approaches to see if full weightbearing affects knee stability or recovery compared to partial weightbearing. It is a randomized controlled trial designed to evaluate recovery outcomes after these knee ligament surgeries. Participants will be randomly assigned to one of two groups for the first six weeks after surgery: partial weightbearing, defined as bearing 40% of their body weight, or full controlled weightbearing with guidance on acceptable exercises and activities. They will wear an immobilizer brace in full extension from day 0 to 13 post-surgery, followed by a specialized knee brace from day 14 to 42 to protect against side-to-side knee movement while weightbearing. During the study, participants will undergo various assessments including X-rays to measure knee joint gapping at six months, pain ratings, swelling, range of motion, walking analysis, muscle strength, and patient-reported outcomes at several time points up to one year. These evaluations will help compare the effects of the two weightbearing approaches on knee healing and function. The total study participation spans from immediately after surgery through follow-up visits over a year to ensure safety and effectiveness of the rehabilitation protocols.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 14Years - 59Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 to under 60 years
  • Undergoing fibular collateral ligament reconstruction alone
  • Undergoing combined fibular collateral ligament and anterior cruciate ligament reconstructions
  • Male or female
  • Willing and able to follow the clinical trial plan and provide informed consent
Not Eligible

You will not qualify if you...

  • Younger than 14 or older than 60 years
  • Pregnant
  • Revision fibular collateral ligament reconstructions
  • Concurrent biceps femoris or lateral capsular repairs
  • Concurrent posterior cruciate ligament or medial collateral ligament reconstructions
  • Concomitant meniscus root or radial repair surgery using transtibial technique

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - 0 to 6 weeks post-surgery

Participants undergo fibular collateral ligament reconstruction surgery and begin post-operative care including use of immobilizer and CTi ligament knee braces.

1 surgery and brace use from day 0 to 42

Treatment

Duration - 6 weeks

Participants follow a rehabilitation protocol with either partial weightbearing (40% body weight) or full controlled weightbearing during the first six weeks post-surgery, supported by physical therapy.

Weekly visits for up to 6 weeks

Follow-up

Duration - Up to 1 year after surgery

Participants have follow-up assessments including pain, edema, range of motion, gait analysis, quadriceps strength, and patient reported outcomes up to 1 year post-surgery.

Visits at 3, 4, 6, 7, 10 months, and 1 year post-surgery

Trial Site Locations

Total: 1 location

1

Twin Cities Orthopedics

Edina, Minnesota, United States, 55435

Actively Recruiting

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Research Team

B

Becky Stone

K

Kayla Seiffert

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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