The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
Recruiting · NCT06162195 · Interventional (participants receive a specific treatment) · Lead sponsor: Embody Orthopaedic Limited
View the official record on ClinicalTrials.gov →Interventions studied
Cementless total hip replacementThe H1 Implant
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
3 locations listed.
- University Hospitals Dorset NHS Foundation Trust - Bournemouth, United Kingdom
- University Hospitals Coventry & Warwickshire - Coventry, United Kingdom
- Royal Cornwall Hospitals NHS Trust - Truro, United Kingdom