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Hip Arthroscopy vs Total Hip Replacement for Hip Osteoarthritis

N/A

Recruiting

Led By Ryan Degen, MD, FRCSC

Research Sponsored by Western University, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 40-60 years at the time of surgery

Patients must have completed ≥3 months of non-operative management with ongoing symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 3, 6 and 12 months

Awards & highlights

Study Summary

This trial will compare the two treatments for early hip osteoarthritis to see which is more effective.

Who is the study for?

This trial is for people aged 40-60 with early hip osteoarthritis (Tönnis Grade 1-2) who've tried non-surgical treatments for at least 3 months without relief. It's not suitable for those with advanced arthritis, pregnant women, prior hip replacements on the other side, or certain hip shapes that make surgery risky.Check my eligibility

What is being tested?

The study compares two procedures: less invasive hip arthroscopy and total hip replacement (arthroplasty), to see which is better for treating early-stage hip osteoarthritis in middle-aged patients.See study design

What are the potential side effects?

Hip arthroscopy may cause joint pain, bleeding, infection or blood clots. Total Hip Arthroplasty can also lead to these issues but includes risks of dislocation, wear of artificial parts over time and possible need for future revision surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 60 years old.

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I've been treated without surgery for over 3 months but still have symptoms.

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My hip X-rays show mild to moderate arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 3, 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 3, 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)

Secondary outcome measures

3-dimensional gait analysis to provide walking characteristics (gait velocity, step length, stride length), kinematics (hip joint angles, pelvic tilt, lateral trunk lean) and kinetics (hip joint moments)

Change in 6-minute Walk Test

Change in Hip Outcome Score

+8 more

Trial Design

2Treatment groups

Active Control

Group I: Total Hip ArthroplastyActive Control1 Intervention

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 II: Hip ArthroscopyActive Control1 Intervention

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Western University, CanadaLead Sponsor

239 Previous Clinical Trials

57,293 Total Patients Enrolled

Ryan Degen, MD, FRCSCPrincipal InvestigatorFowler Kennedy Sport Medicine Clinic

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Hip Arthroscopy Clinical Trial Eligibility Overview. Trial Name: NCT04166227 — N/A

Hip Osteoarthritis Research Study Groups: Total Hip Arthroplasty, Hip Arthroscopy

Hip Osteoarthritis Clinical Trial 2023: Hip Arthroscopy Highlights & Side Effects. Trial Name: NCT04166227 — N/A

Hip Arthroscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04166227 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants has the research team enrolled in this experiment?

"Affirmative. According to clinicaltrials.gov, this clinical trial which was first made public on October 1st 2020 is currently in the process of recruitment. Around 160 individuals are needed at a single site for this study's completion."

Answered by AI

Can individuals eligible for this experiment currently partake in it?

"As detailed on clinicaltrials.gov, this medical research endeavour is actively recruiting participants. The study was launched in October of 2020 and revised most recently on January 13th 2022."

Answered by AI

What type of individual is ideal for this research venture?

"Eligible participants must have arthrosis and be within the age range of 40 to 60. This research is set to recruit a total of 160 individuals."

Answered by AI

Is the enrollment criteria for this trial inclusive of individuals aged 35 and older?

"To be included in this study, one must fulfill the requirements of being between 40 and 60 years old. There are 33 clinical trials that cater to minors below 18 years old, meanwhile 617 studies focus on elderly individuals over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hip Arthroscopy Versus Total Hip Arthroplasty RCT

Ryan Degen 2020. "Hip Arthroscopy Versus Total Hip Arthroplasty RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04166227.