Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for FAI

Panam Clinic

Status: Enrolling

Conditions: Femoro Acetabular Impingement

Treatments: Other: Partial Weight-bearing; Other: Weight-bearing As Tolerated

Study type: Interventional

Funder types: Other

Identifiers

NCT05280899

Hip WB RCT

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Partial Weight-bearing (PWB)

Active Comparator group

Description:

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

Treatment:

Other: Partial Weight-bearing

Weight-bearing As Tolerated (WBAT)

Experimental group

Description:

Patients will WBAT immediately following surgery.

Treatment:

Other: Weight-bearing As Tolerated