Hip Arthroscopy Versus Total Hip Arthroplasty RCT

Western University, Canada

Status: Enrolling

Conditions: Hip Osteoarthritis

Treatments: Procedure: Total Hip Arthroplasty; Procedure: Hip Arthroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04166227

114679

Details and patient eligibility

About

The aim of the proposed study is to perform a comparative pilot, randomized controlled trial of hip arthroscopy versus definitive total hip arthroplasty (THA) for the treatment of early hip osteoarthritis (Tönnis Grade 1-2) in patients between the ages of 40-60 years.

Full description

The purpose of this study is to conduct a randomized trial to compare hip arthroscopy to THR and estimate the long-term cost-effectiveness. Specifically, we aim to:

1. Estimate the magnitude of the between-groups difference in the primary outcome (Hip Dysfunction and Osteoarthritis Outcome Score - HOOS);
2. Evaluate the clinical and cost-effectiveness of early definitive THA compared to arthroscopy for early-stage hip OA at 1-year postoperative;
3. Estimate the lifetime cost-effectiveness of arthroscopy vs THA using a Markov model; and
4. Identify imaging and biomechanical predictors of outcomes following hip arthroscopy

Enrollment: 160 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Between the ages of 40-60 years at the time of surgery.
2. Radiographic evidence of mild to moderate hip OA (Tönnis Gr 0 with MRI chondral wear, Tönnis Gr 1 and 2).
3. Patients must have completed ≥3 months of non-operative management with ongoing symptoms.

Exclusion criteria

1. Advanced OA, defined as <2 mm joint space (Tönnis Gr 3) or those with acetabular or femoral head cysts.
2. Patients who are pregnant or may become pregnant around the time of surgery.
3. Prior arthroplasty of the contralateral hip.
4. Current or prior hip dysplasia (defined by a lateral centre edge angle of <20 degrees).
5. Acetabular protrusio or coxa profunda, making arthroscopic access unsafe/unfeasible.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

Hip Arthroscopy

Active Comparator group

Description:

Patients in the Hip Arthroscopy group will undergo arthroscopy in the supine position under general anesthesia, with all procedures performed by two subspecialty-trained hip arthroscopists. An algorithmic surgical approach will be utilized to sequentially address pathology in the central and peripheral compartments of the hip based on both preoperative imaging findings and intraoperative findings. Emphasis will be placed on labral preservation and refixation, with osseous decompression under fluoroscopic guidance.

Treatment:

Procedure: Hip Arthroscopy

Total Hip Arthroplasty

Active Comparator group

Description:

Patients randomized to the Total Hip Replacement (THR) group will undergo THR via a direct anterior approach. A slightly oblique skin incision measuring approximately 8 cm will be used, starting 3 cm distally and laterally to the anterosuperior iliac spine. The intervals between tensor fascia lata (TFL) and sartorius will be developed superficially, and between rectus femoris and gluteus minimus deeper. Capsulotomy will be performed. A double osteotomy of the femoral neck will be performed to facilitate removal of the head followed by traditional preparation of the acetabulum using an offset reamer and the acetabular component will be inserted. Next, the superior capsule will be released to elevate the femur to allow access to the femoral canal, followed by standard preparation by use of an offset broach and the stem will be implanted

Treatment:

Procedure: Total Hip Arthroplasty