Status:
NOT_YET_RECRUITING
The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
Lead Sponsor:
Embody Orthopaedic Limited
Collaborating Sponsors:
Imperial College London
National Institute for Health Research, United Kingdom
Conditions:
Osteoarthritis, Hip
Inflammatory Arthritis
Eligibility:
All Genders
Phase:
NA
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 ...
Detailed Description
The H1 Implant is a cementless, ceramic hip resurfacing arthroplasty (HRA) device. The intended purpose of the H1 Implant is to provide an artificial substitute for a disease-damaged hip joint to repl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2035
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06162195
Start Date
September 1 2024
End Date
April 1 2035
Last Update
December 8 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.