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Hip implant under the microscope: 5-Year safety study launched

NCT ID NCT05524363

Knowledge-focused Sponsor: Societe dEtude, de Recherche et de Fabrication Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking 120 people who received a HYPE SCS hip stem during total hip replacement. Researchers will monitor how long the implant lasts, how satisfied patients are, and any complications over 5 years. The goal is to confirm the device is safe and works as intended in everyday medical practice.

What this could mean

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

Active substance
HYPE SCS femoral stem (hip implant device)
What this could lead to
If successful, this study will confirm that the HYPE SCS hip stem is safe and works well for up to 5 years after surgery.
What could go wrong
This is an observational study, not a test of a new treatment. It only follows routine care, so it cannot prove the implant is better than others. Results may not apply to all patients.

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

120 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Mar 2027

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

Recruitment of adults patients representing 120 hips operated between 2020 and 2022 (8 patients have been implanted at both hips).

Ages

18 years and older

Sex

Anyone

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: * Patients over 18 years old. * Patients covered by health insurance system * Patients requiring a total hip arthroplasty, implanted swith a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup Exclusion Criteria: * Patient who expressed opposition to participation in the study and to the use of his personal data * Patient unable to understand surgeon's instructions and meet follow-ups requirements * Patient presenting a contraindication indicated in the IFU of both implantsw * Patient presenting a contraindication to have an X-ray * Patients implanted with a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup, in context of off-label use

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Conditions

The condition(s) this trial relates to.

arthropathy osteoarthritis, hip

As listed by the trial registrant

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

Hip arthropathy

Contacts and locations

Locations

  • Centre hospitalier " J. Monod ",

    Flers-en-Escrebieux, 61104, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.