H1 Hip Resurfacing vs Total Hip Replacement in Hip Arthritis

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 randomized trial compares two hip replacement options for adults with hip arthritis: the H1 ceramic resurfacing implant versus a cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement. Participants are assigned to one of the two procedures and followed over time to compare composite clinical success, physical activity, and patient-reported outcomes. The primary aim is to determine non-inferiority of the H1 implant for overall clinical success, with secondary goals evaluating activity levels, PROMs, safety, and patient-reported noise. Secondary analyses will also examine device- and surgery-related adverse events and other outcomes over up to 10 years of follow-up. The study enforces specific inclusion and exclusion criteria to select adults requiring unilateral primary hip arthroplasty and capable of long-term participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient requires unilateral primary hip arthroplasty due to primary osteoarthritis, osteoarthritis secondary to e.g. trauma, avascular necrosis or developmental hip dysplasia, or inflammatory arthritis.
* Patient is willing to comply with study requirements.
* Patient plans to be available through 10 years postoperative follow-up.

Exclusion Criteria:

* Patient has a BMI greater than 40 kg/m².
* Patient has active infection or sepsis (treated or untreated).
* Patient has insufficient bone stock at the hip (\>1/3 necrosis of the femoral head or large and multiple cysts) or in general as in severe osteopenia or osteoporosis (t-score \< -2.5 as measured with BMD).
* Patient is not skeletally mature.
* Patient meets the contraindication criteria of the control device.
* Patient already has another lower limb arthroplasty or arthrodesis or will require a further lower limb arthroplasty or arthrodesis within the subsequent 2 years.
* Patient lacks capacity to consent.
* Patient is unable to understand the native language of the country where their procedure is taking place

Where it's running

• University Hospitals Dorset NHS Foundation Trust
  Bournemouth, United Kingdom Recruiting
• University Hospitals Coventry & Warwickshire
  Coventry, United Kingdom Recruiting
• Royal Cornwall Hospitals NHS Trust
  Truro, United Kingdom Recruiting

Study contacts

• Principal investigator: Justin Cobb, Prof — Imperial College London
• Study coordinator: Camilla Halewood, PhD
• Email: camilla.halewood@embody-ortho.com
• Phone: +442035764981

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Collarless Actis hip stem for cementless hip replacement in Asian patients

  This study tests how well a collarless Actis hip stem works in adults undergoing primary hip replacement, focusing on outcomes over five years in an East Asian population.

  Recruiting Seoul National University Bundang Hospital · Seongnam-si, Gyeonggi-do · NCT07828080

• Intravenous dexamethasone for better pain control after hip replacement with a PENG block

  This study tests whether giving dexamethasone through a vein, in 0, 4, or 8 mg doses, helps control pain after total hip arthroplasty when used with a PENG block.

  Recruiting Poznan University of Medical Sciences · Poznan · NCT07581470

• Long-term follow-up of FX Shoulder Solutions implants

  This follow-up will track adults who receive FX Shoulder Solutions hemi or total shoulder replacements to see if the implants need revision and how well shoulder function and pain hold up over 10 years.

  Recruiting at 22 sites FX Solutions · Amiens and 21 other locations · NCT07558590

• Palliative and supportive care to help people with inflammatory arthritis live well

  This project will see how palliative and supportive care could help adults with inflammatory arthritis live better throughout their illness.

  Recruiting Dorothy House Hospice · Bath, Wiltshire · NCT07491939

• Comparing barbed and conventional wound closure after hip or knee replacement

  This study will test whether barbed sutures or conventional sutures lead to better wound healing and fewer complications for adults having primary or aseptic revision hip or knee replacement.

  Recruiting Umraniye Education and Research Hospital · Istanbul, Istanbul · NCT07439575

• HbA1c accuracy in people with inflammatory arthritis on sulfasalazine

  This study tests whether HbA1c reliably reflects blood glucose in adults with inflammatory arthritis who are treated with sulfasalazine, by comparing it to continuous glucose monitoring.

  Recruiting Central Jutland Regional Hospital · Silkeborg, Central Jutland · NCT07416656

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.