Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction
NCT ID: NCT05073263
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2020-01-01
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Partial weight -bearing for the first six weeks after surgery
Partial weightbearing will be defined as 40% of the patient's body weight.
Physical Therapy
Patient is randomized to the weightbearing group the day after surgery.
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.
Physical Therapy
Patient is randomized to the weightbearing group the day after surgery.
Interventions
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Physical Therapy
Patient is randomized to the weightbearing group the day after surgery.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
59 Years
ALL
Yes
Sponsors
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Twin Cities Orthopedics
OTHER
Responsible Party
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Principal Investigators
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Robert F LaPrade, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Twin Cities Orthopedics
Locations
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Twin Cities Orthopedics
Edina, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Robert F LaPrade, MD, PhD
Role: backup
Other Identifiers
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RFL_FWB vs PWB-FCL
Identifier Type: -
Identifier Source: org_study_id
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