Ceramic hip resurfacing: a Metal-Free future for joint replacement?
NCT ID NCT03326804
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This study is testing a new type of hip resurfacing device made entirely of ceramic, designed for people with hip osteoarthritis, necrosis, or dysplasia. The goal is to see if it is as safe and effective as existing metal-on-metal devices, but without releasing metal ions into the body. Researchers will follow 250 patients for 10 years after surgery, tracking implant survival, pain, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- H1 Hip Resurfacing Arthroplasty device (ceramic-on-ceramic, non-cemented)
- What this could lead to
- If successful, this could offer a longer-lasting, metal-free hip replacement option that avoids metal ion release in the blood.
- What could go wrong
- This is an observational study, not a randomized trial, and long-term results over 10 years are needed to confirm safety and effectiveness. There are risks of complications like implant loosening or fracture.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2017
- Expected to finish
-
Mar 2033
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Indications for use of the H1 HRA in this investigation will be patients with end-stage hip disease who are candidates for primary hip arthroplasty using either a metal-on-metal hip resurfacing or a ceramic-on- ceramic THR. Typically they will be younger (\<70 years) and active males and females with end-stage hip osteoarthritis, avascular necrosis of the femoral head, post-traumatic osteoarthritis or developmental dysplasia of the hip (DDH).
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient requires primary hip arthroplasty due to degenerative joint disease (primary osteoarthritis, posttraumatic osteoarthritis, avascular necrosis, developmental hip dysplasia) * Patient is eligible for hip resurfacing arthroplasty: i.e. has sufficient bone stock at the level of the femoral head (\<1/3 necrosis of the head) and neck (not osteopenic/porotic, see exclusion criteria) * Patient is between 18 and 70 years old * Patient willing to comply with study requirements * Patient is legally entitled and able to consent, agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the informed consent form approved by the Ethics Committee. * Patient plans to be available through ten (10) years postoperative follow-up * Patient is able to understand the native language of the country of the trial centre Exclusion Criteria: * Patient has a BMI greater than 40 * Patient suffers from an active inflammatory joint disorder * Patient has an active infection or sepsis (treated or untreated) * Patient has insufficient bone stock at the hip (\>1/3 necrosis of the femoral head) or in general as in severe osteopenia or osteoporosis (Tscore \< -2.5 as measured with BMD) * At the time of enrolment, patient has one or more of the following arthroplasties that have been * Implanted less than 6 months before the current hip arthroplasty: * Contralateral primary total hip arthroplasty or hip resurfacing arthroplasty * Ipsilateral or contralateral primary total knee or unicondylar knee arthroplasty * Patient takes medications which potentially affect the bone such as corticosteroids and antimitotic medications. * Patient has a condition that may interfere with the hip arthroplasty survival or outcome (i.e. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease) * Patient has a known alcohol or drug abuse * Patient has an immunosuppressive disorder * Patient has a malignant tumour, metastatic, or neoplastic disease * Patient has severe comorbidities or a limited life expectancy * Patient lacks capacity to consent * Patient has an emotional or neurological condition that would pre-empt his/her ability or willingness to participate in the study * Patient is not willing or able to sign an informed consent form * Patient pregnant or breast feeding * Patient is not able or willing to come to follow-up visits * In addition, the following exclusion criteria are applied to the 20 patients (Cohort 1 and Cohort 1.1) in the safety study in whom metal ion measurements will be performed, since those conditions may be associated with elevated metal ion levels and could complicate the interpretation of the metal ion results: * Patients who already received another joint replacement, hip, knee, shoulder, ankle. * Workers in the paint, diamond, leather or other industries producing Co or Cr dust. * Patients taking medication, vitamins or food supplements containing Co or Cr and not able or willing to discontinue those.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Charing Cross Hospital
London, W6 8RF, United Kingdom
-
Kind Edward VII's Hospital
London, United Kingdom
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