Clinical trial NCT05280899: Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for FAI
Official title: The Impact of Varying Weightbearing Restrictions on Postoperative Outcomes Following Arthroscopic Surgery for Femoroacetabular Impingement: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femoro Acetabular Impingement
Lead sponsor: Panam Clinic
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 88
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, single-blinded trial will be completed with patients receiving one of two differing post-operative weightbearing recommendations
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: International Hip Outcome Tool (iHOT-33)
timeFrame: 12 months
Secondary outcomes:
measure: Non-contrast MRI
timeFrame: 0 months
measure: Computed Tomography (CT) Scan
timeFrame: 0 months
measure: The Copenhagen Hip and Groin Outcome Score (HAGOS)
timeFrame: 12 months
measure: Hip Sports Activity Scale (HSAS)
timeFrame: 12 months
measure: Hip Return to Sport after Injury scale (Hip-RSI)
timeFrame: 12 months
measure: Single Assessment Numeric Evaluation (SANE) score
timeFrame: 12 months
measure: Rate of surgical complications, re-operations and revision surgeries
timeFrame: 12 months
measure: Postoperative Pain and Medication
timeFrame: 14 days
measure: Hip Isometric Muscle Strength
timeFrame: 12 months
measure: Hip Isokinetic Muscle Strength
timeFrame: 12 months
measure: Jump Testing
timeFrame: 12 months
measure: Hop Tests
timeFrame: 12 months
measure: 5-0-5 Change of Direction (505)
timeFrame: 12 months
measure: Electromyography of the gluteal muscles
timeFrame: 12 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
Study officials:
affiliation: Pan Am Clinic
name: Devin Lemmex, MD
role: PRINCIPAL_INVESTIGATOR
References: