Hip Arthroscopy Versus Total Hip Arthroplasty RCT

NCT ID: NCT04166227

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2028-01-31

Brief Summary

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.

Detailed 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

Conditions

Hip Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hip Arthroscopy

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.

Group Type: ACTIVE_COMPARATOR

Hip Arthroscopy

Intervention Type: PROCEDURE

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.

Total Hip Arthroplasty

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

Group Type: ACTIVE_COMPARATOR

Total Hip Arthroplasty

Intervention Type: PROCEDURE

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

Interventions

Hip Arthroscopy

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.

Intervention Type: PROCEDURE

Total Hip Arthroplasty

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Ryan Degen

Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Degen, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Fowler Kennedy Sport Medicine Clinic

Locations

Fraser Health

New Westminster, British Columbia, Canada

Site Status: RECRUITING

Fowler Kennedy Sport Medicine Clinic and University Hospital

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Stacey Wanlin

Role: CONTACT

swanlin@uwo.ca

519-661-2111 ext. 82705

Facility Contacts

Parth Lodhia, MD

Role: primary

604-553-9110

Ryan M Degen, MD

Role: primary

ryan.degen@lhsc.on.ca

519-661-2171

Stacey Wanlin

Role: backup

swanlin@uwo.ca

Other Identifiers

114679

Identifier Type: -

Identifier Source: org_study_id