Twin Cities Orthopedics
Edina, Minnesota, 55435, United States
Location status: Recruiting
NCT Number: NCT05073263
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.
Interested in participating?
Request Info14 year–59 year
All sexes
Interventional
Not applicable
Edina, Minnesota, 55435, United States
Location status: Recruiting
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:
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
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient is randomized to the weightbearing group the day after surgery.
Time frame: Pre-operative
stress radiograph
Time frame: 6 months post-surgery
stress radiograph
Time frame: Baseline and 6 months
Pain scale 0-100
Time frame: 4,7, and 10 months after surgery
Measurements with tape
Time frame: 4,7, and 10 months after surgery
Measurements with goniometer
Time frame: 4,7, and 10 months after surgery
Measurements by biomechanics lab
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
Contact information is provided by the study sponsor or research team.
Becky Stone
CONTACT
Kayla Seiffert
CONTACT
Twin Cities Orthopedics
Other
Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: a Randomized Controlled Trial
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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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