Hip Arthroscopy Versus Total Hip Arthroplasty RCT

NCT04166227 | Terminated

• 1 other identifier: 114679
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Osteoarthritis

Keywords

Hip Scope; Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

• Change in Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)

  Subscales measuring Pain, Symptoms, Activity limitations daily living and Function in sport and recreation The outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.

  6 weeks, 3, 6 and 12 months

Secondary Outcomes (11)

• Change in International Hip Outcome Tool [iHOT]

  6 weeks, 3, 6 and 12 months

• Change in Hip Outcome Score

  6 weeks, 3, 6 and 12 months

• Change in Modified Harris Hip Score

  6 weeks, 3, 6 and 12 months

• EQ-5D

  6 weeks, 3, 6 and 12 months

• Cost Utilization

  6 weeks, 3, 6 and 12 months

Study Arms (2)

Hip Arthroscopy

ACTIVE COMPARATOR

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.

Procedure: Hip Arthroscopy

Total Hip Arthroplasty

ACTIVE COMPARATOR

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

Procedure: Total Hip Arthroplasty

Interventions

Hip Arthroscopy 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.

Hip Arthroscopy

Total Hip Arthroplasty 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

Total Hip Arthroplasty

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (2)

Fraser Health

New Westminster, British Columbia, V3L 0E4, Canada

Location

Fowler Kennedy Sport Medicine Clinic and University Hospital

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Ryan Degen, MD, FRCSC

  Fowler Kennedy Sport Medicine Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 18, 2019
• Study Start: October 1, 2020
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CA (2)