Comparing two surgical approaches for hip replacement surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.