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NCT Number: NCT05073263

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

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.

Recruiting

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Key information

Age range

14 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Twin Cities Orthopedics

Edina, Minnesota, 55435, United States

Location status: Recruiting

Location contact

Becky Stone

CONTACT

[email protected]

952-456-7136

Robert F LaPrade, MD, PhD

CONTACT

About this study

Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:

  • partial weightbearing
  • 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

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

Patient is randomized to the weightbearing group the day after surgery.

Primary outcomes

  1. Gapping (mm) measured on Standard of Care Varus stress radiographs

    Time frame: Pre-operative

    stress radiograph

  2. Gapping (mm) measured Standard of Care Varus stress radiographs

    Time frame: 6 months post-surgery

    stress radiograph

Secondary outcomes

  1. Numeric Pain Scale (NPS) (0-10 rating)

    Time frame: Baseline and 6 months

    Pain scale 0-100

  2. Measurements by physical therapists (Edema, thigh circumference)

    Time frame: 4,7, and 10 months after surgery

    Measurements with tape

  3. Measurements by physical therapists (Range of Motion)

    Time frame: 4,7, and 10 months after surgery

    Measurements with goniometer

  4. Measurements by physical therapists (Quadriceps strength, gait analysis)

    Time frame: 4,7, and 10 months after surgery

    Measurements by biomechanics lab

  5. Patient reported outcome scores

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Becky Stone

CONTACT

[email protected]

952-456-7136

Kayla Seiffert

CONTACT

[email protected]

952-456-7085

Sponsors and collaborators

Lead sponsor

Twin Cities Orthopedics

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2021
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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