ACE Acetabular Cup Spanish PMCF Study

NCT ID: NCT07115732

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2036-07-31

Brief Summary

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A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, involving the replacement of both the hip ball and socket. Its goal is to provide pain relief and enable the patient to return to a normal lifestyle. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has an H-A.C. coating to promote osseointegration of the device within the host bone. To increase the surgeon's choice and thus suitability for the patient, there is the option of three different socket liners (ceramic, polymer, or dual mobility).

To ensure maximum safety and performance of medical devices, surveillance of the device should be carried out over the device's lifetime. This study is a 10-year surveillance study to assess the clinical, functional, and radiological outcomes of the CE-marked ACE Acetabular Cup System. This will be done by examining patient outcomes through questionnaires, reviews of X-rays, and recording any complications in patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.

Detailed Description

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Conditions

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Hip Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ACE Acetabular Cup System with XLPE Liner

Total Hip Replacement

Intervention Type DEVICE

Primary elective total hip replacement

ACE Acetabular Cup System with Ceramic Liner

Total Hip Replacement

Intervention Type DEVICE

Primary elective total hip replacement

Interventions

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Total Hip Replacement

Primary elective total hip replacement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients deemed suitable for elective primary THR, as per indications in the IFU.
* Male or female, 18 years to 85 years.

Exclusion Criteria

* Patients who are unable to provide written informed consent.
* Patients deemed unsuitable for THR, as per contra-indications in the IFU.
* Patients indicated for THR as a result of trauma (i.e. neck of femur fracture).
* Patients receiving implants other than the approved combination, i.e. an ACE Acetabular Cup System with a JRI femoral stem and head.
* Patients who are unable to comply with the protocol.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JRI Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital General de Granollers

Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

Other Identifiers

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JRI-CS-011

Identifier Type: -

Identifier Source: org_study_id

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