Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for FAI

NCT ID: NCT05280899

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-04-01

Brief Summary

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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.

Detailed Description

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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. The primary objective is to compare the effects of WBAT or PWB restrictions on PROMS (International Hip Outcome Tool (iHOT33)) and clinical measures following arthroscopic intervention for FAI up to one-year post-operative. The secondary objective will be to assess differences in return to sport (RTS) PROMS, functional performance, and lower extremity kinetics, kinematics, and muscle activity during in patients randomized to either WBAT or PWB at six- and 12-months post-operative. The goal will be to answer if there are differences between a WBAT versus PWB rehabilitation protocol on patient-reported quality of life as measured by the International Hip Outcome Tool (iHOT33) at 12-m post-operative for patients undergoing primary hip arthroscopy for the treatment of FAI.

Conditions

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Femoro Acetabular Impingement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, single-blinded trial will be completed with patients receiving one of two differing post-operative weightbearing recommendations
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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).

Study Groups

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Partial Weight-bearing (PWB)

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

Group Type ACTIVE_COMPARATOR

Partial Weight-bearing

Intervention Type 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.

Weight-bearing As Tolerated (WBAT)

Patients will WBAT immediately following surgery.

Group Type EXPERIMENTAL

Weight-bearing As Tolerated

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Panam Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Devin Lemmex, MD

Role: PRINCIPAL_INVESTIGATOR

Pan Am Clinic

Locations

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Pan Am Clinic

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Dan Ogborn, PhD

Role: CONTACT

204-927-2829

Sheila McRae, PhD

Role: CONTACT

204-925-7469

Facility Contacts

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Dan Ogborn, PhD

Role: primary

204-927-2829

Other Identifiers

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Hip WB RCT

Identifier Type: -

Identifier Source: org_study_id

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