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Can a Bone-Sparing hip implant outperform traditional replacement?

NCT ID NCT06162195

Disease control Sponsor: Embody Orthopaedic Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether a new type of hip resurfacing implant, called the H1, can be as successful as a standard total hip replacement for people with hip arthritis. Participants will receive either the H1 implant or a traditional replacement, and researchers will compare their hip function, complication rates, and physical activity over time. The goal is to see if the H1 offers a better option for preserving mobility and bone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
H1 Implant (a cementless, ceramic hip resurfacing device) compared with a cementless total hip replacement
What this could lead to
If successful, this could offer a less invasive hip replacement option that preserves more bone and may allow greater physical activity for younger, active patients.
What could go wrong
This is a randomized trial, but the new implant may not match the total hip replacement in durability or complication rates. Risks include device breakage, dislocation, or bone fracture around the implant.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2036

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

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

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 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

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Conditions

The condition(s) this trial relates to.

arthritic joint disease osteoarthritis, hip

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammatory arthritis Osteoarthritis, hip

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Royal Cornwall Hospitals NHS Trust

    RECRUITING

    Truro, United Kingdom

  • University Hospitals Coventry & Warwickshire

    RECRUITING

    Coventry, United Kingdom

  • University Hospitals Dorset NHS Foundation Trust

    RECRUITING

    Bournemouth, United Kingdom

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