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Weight-Bearing Restrictions After Surgery for FAI

N/A
Recruiting
Led By Devin Lemmex, MD
Research Sponsored by Panam Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
16 - 50 years of age at time of surgery
Unilateral or bilateral surgical intervention (unilateral required to ensure the weight bearing guidelines are followed)
Must not have
Radiographic criteria: Osteoarthritis greater than Tönnis Grade 1 on affected hip, Lateral central edge angle less than 19°, Dysplasia in patients with broken Shenton line (i.e. Severe acetabular deformity present)
Unable or unwilling to be followed for 1 year or complete functional testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two different types of weight-bearing restrictions following surgery for FAI, to see which results in better outcomes as reported by patients, and as measured by clinical and functional assessments.

Who is the study for?
This trial is for individuals aged 16-50 with diagnosed femoroacetabular impingement (FAI) who've had unsuccessful non-surgical treatments and can commit to a year of follow-up. It's not for those with chronic pain syndromes, language barriers, previous hip diseases or surgeries, ongoing legal claims related to the hip, severe osteoarthritis or dysplasia.
What is being tested?
The study compares two postoperative strategies after arthroscopic surgery for FAI: 'Weight-bearing As Tolerated' (WBAT) versus 'Partial Weight-bearing' (PWB). Participants will be randomly assigned to one of these approaches and monitored up to 12 months to assess their recovery and return to sports activities.
What are the potential side effects?
While the trial itself doesn't involve medication that would cause side effects, participants may experience varying levels of discomfort or mobility issues depending on whether they are in the WBAT or PWB group during their postoperative recovery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 16 and 50 years old.
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I have had surgery on one or both sides of my body to help with weight bearing.
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I have been diagnosed with FAI and experience hip or groin pain related to movement or position.
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I feel better after getting a pain relief shot in my joint.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My hip X-ray shows severe arthritis and abnormal hip shape.
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I cannot or do not want to commit to a year of follow-up or testing.
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I do not have any infections, significant muscle issues, or other health problems that could affect surgery.
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I suffer from long-term pain conditions.
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I cannot speak or read English or French.
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I have had surgery on my hip or major surgery on my lower leg.
Select...
I had a hip disease as a child.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
International Hip Outcome Tool (iHOT-33)
Secondary study objectives
5-0-5 Change of Direction (505)
Computed Tomography (CT) Scan
Electromyography of the gluteal muscles
+11 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: Weight-bearing As Tolerated (WBAT)Experimental Treatment1 Intervention
Patients will WBAT immediately following surgery.
Group II: Partial Weight-bearing (PWB)Active Control1 Intervention
Patients will PWB for 3 weeks following surgery, followed by a gradual return to FWB.

Find a Location

Who is running the clinical trial?

Panam ClinicLead Sponsor
16 Previous Clinical Trials
1,417 Total Patients Enrolled
Devin Lemmex, MDPrincipal InvestigatorPan Am Clinic

Media Library

Weight-bearing As Tolerated (WBAT) Clinical Trial Eligibility Overview. Trial Name: NCT05280899 — N/A
Femoroacetabular Impingement Research Study Groups: Partial Weight-bearing (PWB), Weight-bearing As Tolerated (WBAT)
Femoroacetabular Impingement Clinical Trial 2023: Weight-bearing As Tolerated (WBAT) Highlights & Side Effects. Trial Name: NCT05280899 — N/A
Weight-bearing As Tolerated (WBAT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05280899 — N/A
~33 spots leftby Apr 2026
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