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Clinical Trials in the UK / NCT06162195
Recruiting Not applicable

The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement

NCT06162195 · tracked via the Priya Life Science UK tracker
Sponsor
Embody Orthopaedic Limited
Phase
Not applicable
Started
2026-07-21
Last updated
2026-08-13

Condition(s) studied

Osteoarthritis, HipInflammatory Arthritis

Investigational drug(s) / intervention(s)

The H1 ImplantCementless total hip replacement

The H1 Implant: Patients allocated to The H1 Implant arm will be implanted with the H1 Implant which is a cementless, ceramic hip resurfacing device.

Cementless total hip replacement: Patients allocated to cementless total hip replacement arm will be implanted with a cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite clinical success (CCS) — 24 months post-operatively
    The primary outcome is "composite clinical success". This is a binary outcome measure. Patients are deemed to have achieved CCS if they meet all of the following criteria at the 24 month timepoint: * Modified Harris Hip Score ≥80. * No revision or pending revision. * Acetabular radiolucencies: not in all zones. * Femoral radiolucencies: not in all zones. * Absence of subsidence/migration of the acetabular or femoral component \>5mm with clinical findings. * Absence of specific adverse device effects (ADEs) that are pre-cursors to revision of the device, namely: * Bone breakage around the implanted component(s) (periprosthetic fracture). * Breakage of the device component. * Device movement/migration of clinical consequence as defined by associated clinical findings as: a limp; leg length discrepancy; and restricted range of motion. * Dislocation of the hip joint.

Trial sites (3)

FacilityCityRegionStatus
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

More Embody Orthopaedic Limited trials in the UK

H1 Hip Resurfacing Arthroplasty Active, not recruiting

Other trials for the same condition

Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study Active, not recruiting
Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up Recruiting
PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06162195 on ClinicalTrials.gov ↗ ← All trials in the UK