Hip implant passes 10-Year test

NCT ID NCT03672929

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at how well a specific hip replacement system (the Allofit IT Shell with Longevity Liners) works over 10 years. 197 people with hip problems like arthritis or bone death received the implant. The main goal was to see how many implants were still in place without needing replacement after a decade.

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

197 people

The number who actually took part.

Started

Jun 2011

Finished

Jul 2025

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

The study population will be comprised of 200 males and females who require primary total hip arthroplasty. Subjects must be geographically accessible throughout the study and be willing and able to attend required follow-up appointments. Candidates who express interest in study participation will be offered informed consent, and eligibility will be determined based on the inclusion/exclusion criteria.

Ages

18 to 75 years

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 is skeletally mature. * Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following: * Avascular necrosis (AVN) * Osteoarthritis (OA) * Inflammatory arthritis (i.e. Rheumatoid arthritis) * Post-traumatic arthritis * Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s). * Patient has a Harris Hip Score \<70 in the affected hip * Patient is willing and able to provide written informed consent. * Patient is willing and able to cooperate in the required post-operative therapy. * Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. * Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent. Exclusion Criteria: * The patient is: * A prisoner * Mentally incompetent or unable to understand what participation in the study entails * A known alcohol or drug abuser * Anticipated to be non-compliant. * The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care. * The patient has a vascular (large and small vessel disease) insufficiency. * The patient has a neurologic condition in the ipsalateral or contralateral limb which affects lower limb function. * The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome. * The patient is known to be pregnant. * The patient is unwilling or unable to give informed consent, or to comply with the follow-up program. * The patient has received an investigational drug or device within the previous 6 months. * The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously. * The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock. * The patient has osteoradionecrosis in the operative hip joint * The patient has a known sensitivity or allergic reaction to one or more of the implanted materials. * The patient has known local bone tumors in the operative hip. * The patient is Grade III obese with a Body Mass Index (BMI) \> 40.

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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

  • Klinik Vincentium

    Augsburg, 86199, Germany

  • Kliniken Dr. Erler

    Nuremberg, 90429, Germany

  • Medizinische Universität Wien, Universitätsklinik für Orhopädie

    Vienna, 1090, Austria

  • Service Clinique Chirurgicale Orthopédique et Traumatologique de l'hôpital "Hotel-Dieu"

    Nantes, 44093, France

  • Traumatoloy and Orthopaedic Surgery, Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela, 15776, Spain

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