NCT06162195 The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
| NCT ID | NCT06162195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Embody Orthopaedic Limited |
| Condition | Osteoarthritis, Hip |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-07-21 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-07-21 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomised controlled trial is to compare the success of two types of hip replacement in patients with hip arthritis. The main question it aims to answer is whether a new type of hip replacement (called a hip resurfacing) can be as successful as an existing hip replacement (called a total hip replacement). Patients will be given either the new hip resurfacing or the existing total hip replacement and researchers will compare their function, complication rate and physical activity.
Eligibility Criteria
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
Contact & Investigator
Justin Cobb, Prof
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT06162195 clinical trial?
This trial is open to participants of all sexes, studying Osteoarthritis, Hip. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06162195 currently recruiting?
Yes, NCT06162195 is actively recruiting participants. Contact the research team at camilla.halewood@embody-ortho.com for enrollment information.
Where is the NCT06162195 trial being conducted?
This trial is being conducted at Bournemouth, United Kingdom, Coventry, United Kingdom, Truro, United Kingdom.
Who is sponsoring the NCT06162195 clinical trial?
NCT06162195 is sponsored by Embody Orthopaedic Limited. The principal investigator is Justin Cobb, Prof at Imperial College London. The trial plans to enroll 200 participants.