Recruiting

Weightbearing Comparison

Sponsor:

Twin Cities Orthopedics

Code:

NCT05073263

Conditions

Knee Injuries

Eligibility Criteria

Sex: All

Age: 14 - 59

Healthy Volunteers: Accepted

Interventions

Physical Therapy

Study Details

Brief 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.

Conditions

Knee Injuries

Study ID

NCT05073263

Start date

Jan 1, 2020

Status verified date

Nov, 2024

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 59

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Physical Therapy

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

Primary outcome measure

  • Gapping (mm) measured on Standard of Care Varus stress radiographs [ Time Frame: Pre-operative ]
  • Gapping (mm) measured Standard of Care Varus stress radiographs [ Time Frame: 6 months post-surgery ]

Central Contacts and Locations

Central contacts

Becky Stone

952-456-7136research@tcomn.com

Kayla Seiffert

952-456-7085research@tcomn.com

Locations

Twin Cities Orthopedics

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Becky Stone

952-456-7136research@tcomn.com

More Information

Sponsor

Twin Cities Orthopedics

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Keywords

  • fibular collateral ligament (FCL)
  • anterior cruciate ligament (ACL)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Twin Cities Orthopedics on 2024-11-22.