Allofit® IT With HXPE in Total Hip Arthroplasty

January 26, 2026 updated by: Zimmer Biomet

Allofit® IT With HXPE in Total Hip Arthroplasty. A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

The study design is a multi-center, prospective, non-controlled, consecutive cohort postmarket clinical follow-up study to obtain survival and outcome data on the Allofit IT Shell in combination with Longevity Liners in primary total hip arthroplasty.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will involve orthopedic surgeons skilled in total hip arthroplasty and experienced with the implants subject of this study. In total, 5 centers will be involved. This number of clinical sites will permit assessment of the consistency among a multitude of Investigators. A total number of 200 subjects will be included in the study. It is anticipated that each clinical site will enroll 40-60 eligible study subjects, who have provided written informed consent.

Ethics Committee (EC) approval for each site has to be obtained prior to conducting this research. Sequentially, all eligible patients will be offered study enrollment at each center to avoid potential selection bias. All potential subjects will be required to participate in an informed consent process and sign an EC approved written informed consent prior to study enrollment. It is anticipated the enrollment period may be 12 months or longer to assure an adequate number of cases at each site. Each case enrolled will receive an Allofit IT HXPE Bearing System. The study is designed to be prospective to ensure that the study population is representative of the type of population that the device is intended to treat. The subjects included will be candidates for All subjects will undergo preoperative clinical, functional and radiographic evaluations, total hip arthroplasty, immediate post-operative evaluations and post-operative clinical, functional and radiographic evaluations at 6 months (± 1 month), 1 year (± 2 months), 2 year (± 2 months), 3 year (± 2 months), 5 year (± 2 months), 7 year (± 2 months), and 10 year (± 2 months).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medizinische Universität Wien, Universitätsklinik für Orhopädie
  • France
      • Nantes, France, 44093
        • Service Clinique Chirurgicale Orthopédique et Traumatologique de l'hôpital "Hotel-Dieu"
  • Germany
      • Augsburg, Germany, 86199
        • Klinik Vincentium
      • Nuremberg, Germany, 90429
        • Kliniken Dr. Erler
  • Spain
      • Santiago de Compostela, Spain, 15776
        • Traumatoloy and Orthopaedic Surgery, Complejo Hospitalario Universitario de Santiago de Compostela

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients who received the Allofit IT with HXPE
Subjects in need of a primary total hip arthroplasty, who met the inclusion/exclusion criteria and who received the Allofit IT Shell in combination with the Longevity HXPE Liners

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survival of the Implant System
Time Frame: 10 years post-surgery
The objective of this study is implant survival at 10 years which is assessed by revision of the the study device. Survivorship at 10 years was defined as cases that had the implant still in place at 10 years.
10 years post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety of the Implant System
Time Frame: 10 years post-surgery
Safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
10 years post-surgery
Harris Hip Score (HHS)
Time Frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
The Harris Hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70
pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
EQ-5D-3L Score
Time Frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes five dimensions referring to mobility, self-care, daily activities,pain/discomfort, and anxiety/depression. Each question can be answered in three ways/levels indicating no problems, some problems, and extreme problems. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.594;negative numbers correspond to a self-assessed health state worse than being dead. Higher scores mean a better outcome.
pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
EQ-5D VAS
Time Frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her current state of health. Higher scores mean a better outcome.
pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Oxford Hip Score
Time Frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27. Higher scores mean a better outcome.
pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
UCLA Activity Score
Time Frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
The case administered University of California at Los Angeles (UCLA) score allows assessment of the case's activity level at each time point with scores from 1 (Wholly inactive: dependent on others; cannot leave residence) to 10 (Regularly participates in impact sports). Higher scores mean a better outcome
pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Evaluations - Acetabular Site
Time Frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence,heterotopic ossification, etc
pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
Radiographic Evaluations - Femoral Side
Time Frame: pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence,heterotopic ossification, etc
pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Implant stability by Roentgen Stereometric Analysis (RSA)
Time Frame: 2 years post-surgery
Roentgen Stereometric Analysis (RSA) is a very accurate measurement technique used to obtain micromotion of the implants relative to bone, by means of inserted tantalum markers in the surrounding acetabulum and femur. RSA provides data on the in-vivo stability of the Cup System within 2 years. The RSA Evaluation is completed by the Investigator or its designee upon review of the protocol required RSA images.
2 years post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zimmer Biomet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Emilie Rohmer, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CME2010-25H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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