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RECRUITING

NCT05280899

Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for FAI

Sponsor: Panam Clinic

View on ClinicalTrials.gov

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 weight-bearing (PWB) restrictions following arthroscopic surgery for femoroacetabular impingement (FAI) up to 12-months postoperative.

Official title: The Impact of Varying Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for Femoroacetabular Impingement: a Randomized Trial

Key Details

Gender

All

Age Range

16 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-09-01

Completion Date

2026-04-01

Last Updated

2024-04-02

Healthy Volunteers

Conditions

Femoro Acetabular Impingement

Interventions

OTHER

Weight-bearing As Tolerated

The WBAT group will be instructed to bear weight as tolerated immediately following their surgical procedure. The rehabilitation protocols provided will be identical beyond the initial weightbearing recommendations. Following the initial protection phase (three weeks), whereby the two weightbearing interventions will be provided, patients will progress through standardized phases including mobility and neuromuscular retraining, muscle balance and strengthening, functional training, and finally, advanced training for return to work and sport.

OTHER

Partial Weight-bearing

The PWB group will be instructed to bear weight to a maximum of 20 lbs of bodyweight on the operative limb for the initial three weeks (termed "toe touch"), with graduated return to full weightbearing thereafter.

Inclusion Criteria: * 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: 1. Symptoms of motion- or position-related pain in the hip or groin 2. Clinical signs consistent with FAI such as: decreased hip flexion and internal rotation, or positive impingement sign 3. 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 Criteria: 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)

Locations (1)

Pan Am Clinic

Winnipeg, Manitoba, Canada