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Weightbearing Strategies for Knee Injury Rehab

N/A
Recruiting
Led By Robert F LaPrade, MD, PhD
Research Sponsored by Twin Cities Orthopedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 14 years old, <60
Combined FCL + ACL reconstructions
Must not have
< 14 years old, > 60
Concurrent biceps femoris or lateral capsular repairs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4,7, and 10 months after surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if patients can safely put weight on their reconstructed knee sooner than the standard protocol.

Who is the study for?
This trial is for males and females aged 14 to 60 who are undergoing fibular collateral ligament (FCL) reconstruction, with or without anterior cruciate ligament (ACL) surgery. Participants must be able to follow the study plan and give informed consent. It's not for those with certain other knee surgeries, pregnant individuals, under 14 or over 60 years old.
What is being tested?
The study is testing whether patients can safely start full weightbearing during the first six weeks of rehab after FCL reconstruction alone or combined with ACL surgery. This will be determined through a randomized controlled trial comparing full versus partial weightbearing.
What are the potential side effects?
Since this trial involves physical therapy rather than medication, side effects may include discomfort, swelling, or pain at the site of injury during rehabilitation exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 14 and 59 years old.
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I have had both FCL and ACL knee reconstructions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am younger than 14 or older than 60.
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I am undergoing or have undergone repairs on my thigh muscle or outer knee capsule.
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I am having surgery to repair a knee injury using a specific technique.
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I am having or have had surgery to repair my PCL or MCL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4,7, and 10 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4,7, and 10 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Gapping (mm) measured Standard of Care Varus stress radiographs
Gapping (mm) measured on Standard of Care Varus stress radiographs
Secondary study objectives
Measurements by physical therapists (Edema, thigh circumference)
Measurements by physical therapists (Quadriceps strength, gait analysis)
Measurements by physical therapists (Range of Motion)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Full weight -bearing for the first six weeks after surgeryExperimental Treatment1 Intervention
If the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities.
Group II: Partial weight -bearing for the first six weeks after surgeryActive Control1 Intervention
Partial weightbearing will be defined as 40% of the patient's body weight.

Find a Location

Who is running the clinical trial?

Twin Cities OrthopedicsLead Sponsor
3 Previous Clinical Trials
877 Total Patients Enrolled
2 Trials studying Knee Injuries
77 Patients Enrolled for Knee Injuries
Robert F LaPrade, MD, PhDPrincipal InvestigatorTwin Cities Orthopedics
2 Previous Clinical Trials
77 Total Patients Enrolled
2 Trials studying Knee Injuries
77 Patients Enrolled for Knee Injuries

Media Library

Anterior Cruciate Ligament Reconstruction Clinical Trial Eligibility Overview. Trial Name: NCT05073263 — N/A
Knee Injuries Research Study Groups: Partial weight -bearing for the first six weeks after surgery, Full weight -bearing for the first six weeks after surgery
Knee Injuries Clinical Trial 2023: Anterior Cruciate Ligament Reconstruction Highlights & Side Effects. Trial Name: NCT05073263 — N/A
Anterior Cruciate Ligament Reconstruction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05073263 — N/A
~8 spots leftby Jan 2026
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