Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for FAI

NCT05280899 | Recruiting

• 1 other identifier: Hip WB RCT
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Femoro Acetabular Impingement

Outcome Measures

Primary Outcomes (1)

• International Hip Outcome Tool (iHOT-33)

  The iHOT uses 33 questions to measure health-related quality of life. It is the primary outcome and has been validated for use in this population. Questions are evaluated on a 100-point visual analog scale (VAS) response format, where "0" represents the worst possible quality of life, and "100" represents the the best.

  12 months

Secondary Outcomes (14)

• Non-contrast MRI

  0 months

• Computed Tomography (CT) Scan

  0 months

• The Copenhagen Hip and Groin Outcome Score (HAGOS)

  12 months

• Hip Sports Activity Scale (HSAS)

  12 months

• Hip Return to Sport after Injury scale (Hip-RSI)

  12 months

Study Arms (2)

Partial Weight-bearing (PWB)

ACTIVE COMPARATOR

Patients will PWB for 3 weeks following surgery, followed by a gradual return to FWB.

Other: Partial Weight-bearing

Weight-bearing As Tolerated (WBAT)

EXPERIMENTAL

Patients will WBAT immediately following surgery.

Other: Weight-bearing As Tolerated

Interventions

Weight-bearing As Tolerated OTHER

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.

Weight-bearing As Tolerated (WBAT)

Partial Weight-bearing OTHER

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.

Partial Weight-bearing (PWB)

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Panam Clinic: lead

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Weight-Bearing; Partial Weight-Bearing

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Devin Lemmex, MD

  Pan Am Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Ogborn, PhD

CONTACT

204-927-2829; dogborn@panamclinic.com

Sheila McRae, PhD

CONTACT

204-925-7469; smcrae@panamclinic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients and surgeons will not be blinded to group allocation (weight-bearing status). The study Research Coordinator will perform randomization therefore they will also not be blinded to group allocation. The assessor for the functional and return to sport outcomes will be blinded to group allocation. To protect blinding, before each functional testing appointment, the blinded tester will remind patients not to reveal their group (weightbearing status).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, single-blinded trial will be completed with patients receiving one of two differing post-operative weightbearing recommendations

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: March 15, 2022
• Study Start: September 1, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)