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New hip implant tested for safer fracture repair

NCT ID NCT06885359

Disease control Sponsor: Limacorporate S.p.a 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study looks at how well a specific hip implant (CoCrMo LOCK bipolar femoral head) works for people who have had a hip fracture. Researchers will check how many patients need a second surgery or experience complications like dislocation within two years. The study includes 60 adults who received this implant starting in 2023 and who could walk before their fracture.

What this could mean

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

Active substance
CoCrMo LOCK bipolar femoral head (hip implant)
What this could lead to
If the implant performs well, it could confirm a safe and effective option for hip fracture repair, reducing the need for repeat surgeries.
What could go wrong
This is a small, observational study with no comparison group, so results may not apply to all patients. Implants can still fail or cause complications like dislocation or infection.

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 60 people

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

Started

Jan 2026

Expected to finish

Dec 2028

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

Patients who underwent partial hip arthroplasty with CoCrMo LOCK bipolar femoral heads from 1st January 2023 onwards

Ages

18 years and older

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: * Displaced intracapsular hip fracture (Garden III-IV). * Subjects underwent a Bipolar Hemiarthroplasty with a CoCrMo LOCK Bipolar femoral head as per their Indication For Use from January 1st, 2023, onwards. * No concurrent joint disease at the time of the surgery. * Absence of severe cognitive dysfunction demonstrated by 3 or more correct answers on the Pfeiffer test. * Ability to ambulate independently with or without walking aids before surgery. * Subject willingness to participate. Exclusion Criteria: * Undisplaced or minimally displaced intracapsular hip fracture (Garden I-II). * Any CoCrMo LOCK Bipolar femoral head contraindication for use as reported in the current Instruction For Use. * Pathological fracture secondary to malignant disease. * Subjects with rheumatoid arthritis or symptomatic osteoarthritis. * Previous treatment to the same hip for a fracture at the time of the surgery. * Subjects who were deemed unsuitable for the surgical procedures by the anesthesiologist. * Severe cognitive dysfunction or cognitive impairment demonstrated by 2 or less correct answers on the Pfeiffer test. * Unable to walk before surgery (e.g., wheelchair or bed-ridden subjects).

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Conditions

The condition(s) this trial relates to.

Femoral Fractures femoral neck fracture hip fracture osteoarthritis, hip

As listed by the trial registrant

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

Femoral fractures Hip arthropathy

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Splošna bolnišnica Celje

    RECRUITING

    Celje, 3000, Slovenia

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