160 Participants Needed

Hip Arthroscopy vs Total Hip Replacement for Hip Osteoarthritis

Recruiting at 1 trial location
SW
AM
SH
Overseen ByStephanie Horst, BSc, CCRP
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Western University, Canada
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Hip Arthroscopy vs Total Hip Replacement for Hip Osteoarthritis?

Research shows that hip arthroscopy can improve pain and function in the short term, but some patients may still need a total hip replacement later. Total hip replacement generally provides significant improvement in function for those with severe osteoarthritis.12345

Is hip arthroscopy or total hip replacement generally safe for humans?

Hip arthroscopy is generally considered safe with a relatively low complication rate, though some complications may be underreported. Total hip replacement is a common follow-up procedure after hip arthroscopy, and while it can be more challenging if done after arthroscopy, it does not significantly affect clinical outcomes.678910

How does the treatment of hip arthroscopy differ from total hip replacement for hip osteoarthritis?

Hip arthroscopy is a minimally invasive procedure aimed at preserving the hip joint and is often used to treat hip pain and other issues before they become severe. In contrast, total hip replacement (also known as total hip arthroplasty) involves replacing the entire hip joint and is typically used when the joint is significantly damaged, such as in advanced osteoarthritis.2491112

What is the purpose of this trial?

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.

Research Team

RD

Ryan M Degen, MD

Principal Investigator

Fowler Kennedy Sport Medicine Clinic

Eligibility Criteria

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.

Inclusion Criteria

My hip X-rays show mild to moderate arthritis.
I am between 40 and 60 years old.
I've been treated without surgery for over 3 months but still have symptoms.

Exclusion Criteria

I have or had hip dysplasia, with a specific hip angle measurement.
I have had hip replacement surgery on the opposite side.
Patients who are pregnant or may become pregnant around the time of surgery
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either hip arthroscopy or total hip arthroplasty based on randomization

6 weeks
1 visit (in-person) for surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 weeks, 3, 6, and 12 months

12 months
Multiple visits (in-person) at 6 weeks, 3, 6, and 12 months

Long-term cost-effectiveness analysis

Estimate the lifetime cost-effectiveness of arthroscopy vs THA using a Markov model

Treatment Details

Interventions

  • Hip Arthroscopy
  • Total Hip Arthroplasty
Trial Overview 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.
Participant Groups
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.

Hip Arthroscopy is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Hip Arthroscopy for:
  • Labral tears
  • Femoroacetabular impingement (FAI)
  • Synovitis
  • Chondral lesions
  • Loose bodies
🇺🇸
Approved in United States as Hip Arthroscopy for:
  • Labral tears
  • Femoroacetabular impingement (FAI)
  • Synovitis
  • Chondral lesions
  • Loose bodies
  • Mild to moderate hip osteoarthritis
🇨🇦
Approved in Canada as Hip Arthroscopy for:
  • Labral tears
  • Femoroacetabular impingement (FAI)
  • Synovitis
  • Chondral lesions
  • Loose bodies
🇯🇵
Approved in Japan as Hip Arthroscopy for:
  • Labral tears
  • Femoroacetabular impingement (FAI)
  • Synovitis
  • Chondral lesions
  • Loose bodies

Find a Clinic Near You

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials
270
Recruited
62,500+

Findings from Research

In a study of 1417 patients undergoing hip arthroscopic surgery, significant improvements were observed in patient-reported outcome scores (PROs) at the 2-year follow-up, indicating effective pain management and functional recovery after surgery.
There was a moderate correlation between pain levels measured by the visual analog scale (VAS) and patient satisfaction, as well as changes in the four PRO scores, suggesting that both VAS and satisfaction assessments are valuable for evaluating surgical outcomes.
Correlation Between Changes in Visual Analog Scale and Patient-Reported Outcome Scores and Patient Satisfaction After Hip Arthroscopic Surgery.Chandrasekaran, S., Gui, C., Walsh, JP., et al.[2020]
Patients who underwent total hip arthroplasty (THA) after a previous hip arthroscopy had satisfactory functional outcomes, but these outcomes were significantly worse compared to patients who had THA for primary osteoarthritis, based on Oxford Hip Scores.
Despite the difference in functional outcomes, the rate of complications was similar between the two groups, indicating that previous hip arthroscopy does not increase the risk of complications during THA.
Functional outcome of total hip arthroplasty after a previous hip arthroscopy: a retrospective comparative cohort study.Jain, MV., Rajpura, A., Kumar, VS., et al.[2022]
Patients who had undergone hip arthroscopy (HA) before total hip arthroplasty (THA) experienced significantly lower rates of medical complications, such as readmission and pulmonary embolism, compared to those without prior HA, suggesting a potential protective effect of previous HA on postoperative outcomes.
The prior HA cohort also showed a reduced likelihood of prolonged opioid use after THA, with fewer patients filing opioid claims beyond 30 days post-surgery, indicating that previous HA may help in managing pain and reducing dependency on opioids after surgery.
Is Prior Hip Arthroscopy Associated With Higher Complication Rates or Prolonged Opioid Claims After Total Hip Arthroplasty? A Matched Cohort Study.Ross, BJ., Wortman, RJ., Lee, OC., et al.[2022]

References

Correlation Between Changes in Visual Analog Scale and Patient-Reported Outcome Scores and Patient Satisfaction After Hip Arthroscopic Surgery. [2020]
Functional outcome of total hip arthroplasty after a previous hip arthroscopy: a retrospective comparative cohort study. [2022]
Is Prior Hip Arthroscopy Associated With Higher Complication Rates or Prolonged Opioid Claims After Total Hip Arthroplasty? A Matched Cohort Study. [2022]
Hip arthroscopy in the setting of hip osteoarthritis: systematic review of outcomes and progression to hip arthroplasty. [2022]
Hip Arthroscopy Results in Similar Short-Term Function Compared to Total Hip Arthroplasty in Patients of Similar Demographic Profiles. [2022]
Satisfaction, functional outcomes and predictors in hip arthroscopy: a cohort study. [2022]
Evaluation of primary hip arthroscopy complications in mid-term follow-up: a multicentric prospective study. [2022]
Complications of Hip Arthroscopy: Patient Perspectives. [2022]
Prior Arthroscopy Leads to Inferior Outcomes in Total Hip Arthroplasty: A Match-Controlled Study. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Hip arthroscopy for hip osteoarthritis is associated with increased risk for revision after total hip arthroplasty. [2022]
Status of Hip Arthroscopy in India: A Short Questionnaire Based Survey and Review of Literature. [2022]
Hip arthroscopy in the setting of hip arthroplasty. [2022]
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