Last updated: April 1, 2024
Sponsor: Panam Clinic
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Weight-bearing As Tolerated
Partial Weight-bearing
Clinical Study ID
NCT05280899
Hip WB RCT
Ages 16-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 16 - 50 years of age at time of surgery
- Diagnosis of FAI (cam, pincer, mixed) based on the 2016 Warwick Agreement. All 3criteria below must be met:
- Symptoms of motion- or position-related pain in the hip or groin
- Clinical signs consistent with FAI such as: decreased hip flexion and internalrotation, or positive impingement sign
- Radiographic evidence (on BOTH x-ray AND non-contrast MRI) of intra-articularpathology consistent with FAI as determined by the treating surgeon.
- Failed conservative interventions of at least 3 months (i.e. physiotherapy)
- Have symptom relief with intra-articular injection of local anaesthetic
- Unilateral or bilateral surgical intervention (note: unilateral required to ensure theweight bearing guidelines are followed)
- Are willing to be followed for 12 months post-operative. Eligibility for 'return to sport' cohort: Additional assessment measures related to return to sport will be collected on the patientwho meet the following criteria:
- are or were previously actively involved in sport as indicated by a pre-operative HipSports Activity Scale score of four of greater
- indicate a post-operative goal to return to sport following their procedure
Exclusion
Exclusion Criteria: Clinical:
- Previous surgery on the affected hip, or other major lower extremity orthopaedicsurgery
- Active joint or systemic infection, significant muscle paralysis, significant lowerextremity or medical comorbidity that could alter the effectiveness of the surgicalintervention (e.g. polymyalgia rheumatica)
- Unable to speak or read English/French
- Unable or unwilling to be followed for 1 year or complete functional testing
- Presence of chronic pain syndromes
- History of pediatric hip disease (i.e. Slipped Capital Femoral Epiphysis,Legg-Calve-Perthes Disease)
- Ongoing litigation or compensation claims related to the hip (including Workers'Compensation) Radiographic:
- Osteoarthritis greater than Tönnis Grade 1 on affected hip
- Lateral central edge angle <19°
- Dysplasia in patients with broken Shenton line (i.e. Severe acetabular deformitypresent)
Study Design
Total Participants: 88
Treatment Group(s): 2
Primary Treatment: Weight-bearing As Tolerated
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
April 01, 2026
Study Description
Connect with a study center
Pan Am Clinic
Winnipeg, Manitoba R3M 3E4
CanadaActive - Recruiting

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