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Weightbearing Strategies After Knee Ligament Surgery for Knee Injuries

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
Reconstruction of multiligament injuries (ACL+MCL)
Reconstruction of PCL alone
Must not have
Previous or concurrent vascular injury (vascular bypass procedure)
< 14 years old
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 whether it is safe for patients who have had surgery on their posterior cruciate ligament, medial collateral ligament, or a combination of multiple ligaments, to start partial weightbearing six weeks after surgery.

Who is the study for?
This trial is for individuals aged between 14 and 60 who have had surgery to repair a knee ligament injury, such as the PCL alone or in combination with other ligaments like ACL and MCL. Participants must be able to follow the study plan and give informed consent. It's not open to those with certain concurrent surgeries, previous vascular injuries, pregnant women, or anyone needing revision PCL reconstructions.
What is being tested?
The study is testing whether patients can safely start partial controlled weightbearing during the first six weeks after reconstructive knee surgery. This involves comparing two approaches: non-weightbearing versus partial weightbearing post-surgery through randomized assignment of participants.
What are the potential side effects?
While specific side effects are not listed for physical therapy interventions, potential risks may include pain at the site of injury, swelling, stiffness in the knee joint area, or aggravation of existing conditions due to movement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had surgery to repair both my ACL and MCL.
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I am having surgery to reconstruct my PCL only.
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I am having surgery to reconstruct my MCL only.
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I am between 14 and 59 years old.
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I had surgery to repair multiple torn ligaments in my knee.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a vascular bypass procedure.
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I am under 14 years old.
Select...
I am over 60 years old.
Select...
I need surgery for fractures related to my condition.
Select...
I am having or have had a revision of my PCL surgery.
Select...
I am having surgery to repair a knee injury.

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 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: Partial weight -bearing for the first six weeks after surgeryExperimental Treatment1 Intervention
Partial weightbearing will be defined as 40% of the patient's body weight.
Group II: Non-weightbearing for the first six weeks after surgeryActive Control1 Intervention
Not weightbearing after surgery

Find a Location

Who is running the clinical trial?

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

Media Library

Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05073276 — N/A
Knee Injuries Research Study Groups: Non-weightbearing for the first six weeks after surgery, Partial weight -bearing for the first six weeks after surgery
Knee Injuries Clinical Trial 2023: Physical Therapy Highlights & Side Effects. Trial Name: NCT05073276 — N/A
Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05073276 — N/A
~9 spots leftby Jan 2026
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