Comparing two surgical approaches for hip replacement surgery
Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty: a Multicenter Double Blinded Randomized Controlled Trial
NA · Isala · NCT06342843
This study is testing which of two surgical methods for hip replacement helps people with severe hip arthritis feel better and recover faster.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 211 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Isala (other) |
| Locations | 3 sites (Breda, North Brabant and 2 other locations) |
| Trial ID | NCT06342843 on ClinicalTrials.gov |
What this trial studies
This study compares the direct superior approach (DSA) and the posterolateral approach (PLA) in total hip arthroplasty (THA) for patients with incapacitating hip osteoarthritis. It aims to evaluate postoperative pain, health-related quality of life (HRQoL), physical function, and muscle atrophy, among other factors. The study employs a multicenter, double-blinded, randomized controlled design, ensuring that neither patients nor researchers know which surgical method is used until one year post-surgery. A total of 211 participants will be enrolled to assess the effectiveness of each approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptomatic incapacitating hip osteoarthritis who are indicated for total hip arthroplasty.
Not a fit: Patients with previous hip surgery, severe obesity, or certain neurological and cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing hip replacement surgery.
How similar studies have performed: Previous studies have shown varying success with different surgical approaches in hip arthroplasty, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subject * Has symptomatic incapacitating coxarthrosis in whom total hip arthroplasty (THA) is indicated, diagnosed by both physical examination and pelvic/hip X-ray * Has signed informed consent * Is ageing 18 years or older at time of study entry * Is competent and able to participate in follow-up Exclusion Criteria: * Previous ipsilateral hip surgery * BMI \>35 kg/m2 * Contralateral incapacitating coxarthrosis, diagnosed by both physical examination and pelvic/hip X-ray * Neurological conditions influencing walking pattern * Inability to walk without walking aid preoperatively * Rheumatoid arthritis (RA) * Severe hip dysplasia * Cognitive impairment * Malignancies or metastases involving the hip joint or the nearby soft tissues * Inability to speak and write Dutch language
Where this trial is running
Breda, North Brabant and 2 other locations
- Amphia — Breda, North Brabant, Netherlands (RECRUITING)
- Isala — Zwolle, Overijssel, Netherlands (RECRUITING)
- Medisch Centrum Leeuwarden — Leeuwarden, Provincie Friesland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Harmen B. Ettema, MD/PhD — Isala
- Study coordinator: Harmen Ettema, MD/PhD
- Email: h.b.ettema@isala.nl
- Phone: 0031886245656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoarthritis, Hip