Status:
RECRUITING
Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for FAI
Lead Sponsor:
Panam Clinic
Conditions:
Femoro Acetabular Impingement
Eligibility:
All Genders
16-50 years
Phase:
NA
Brief Summary
The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients randomized to weight-bearing as tolerated (WBAT) or partial ...
Detailed Description
The purpose of this single-blinded (assessor) randomized trial is to compare patient-reported, clinical and functional outcomes in patients randomized to weight-bearing as tolerated (WBAT) or partial ...
Eligibility Criteria
Inclusion
- 16 - 50 years of age at time of surgery
- Diagnosis of FAI (cam, pincer, mixed) based on the 2016 Warwick Agreement. All 3 criteria 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 internal rotation, or positive impingement sign
- Radiographic evidence (on BOTH x-ray AND non-contrast MRI) of intra-articular pathology 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 the weight 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 patient who meet the following criteria:
- are or were previously actively involved in sport as indicated by a pre-operative Hip Sports Activity Scale score of four of greater
- indicate a post-operative goal to return to sport following their procedure
Exclusion
- Clinical:
- Previous surgery on the affected hip, or other major lower extremity orthopaedic surgery
- Active joint or systemic infection, significant muscle paralysis, significant lower extremity or medical comorbidity that could alter the effectiveness of the surgical intervention (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 deformity present)
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05280899
Start Date
September 1 2022
End Date
April 1 2026
Last Update
April 2 2024
Active Locations (1)
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1
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M 3E4