Hip implant passes 10-Year test
NCT ID NCT03672929
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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197 people
The number who actually took part.
- Started
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Jun 2011
- Finished
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Jul 2025
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 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
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Klinik Vincentium
Augsburg, 86199, Germany
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Kliniken Dr. Erler
Nuremberg, 90429, Germany
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Medizinische Universität Wien, Universitätsklinik für Orhopädie
Vienna, 1090, Austria
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Service Clinique Chirurgicale Orthopédique et Traumatologique de l'hôpital "Hotel-Dieu"
Nantes, 44093, France
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Traumatoloy and Orthopaedic Surgery, Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, 15776, Spain
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