Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07115732

ACE Acetabular Cup Spanish PMCF Study

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hip Disease

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Granollers

Barcelona, Catalonia, 08402, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 who are pregnant (exclusion criteria for THR in general).
  • 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.

Treatment and study plan

Total Hip Replacement

Device

Primary elective total hip replacement

Primary outcomes

  1. Oxford Hip Score

    Time frame: 3 years post-op

    A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best)

Secondary outcomes

  1. Implant Survivorship

    Time frame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op

    Implant survivorship based on revision rate and determined using the Kaplan-Meier analysis method

  2. Oxford Hip Score

    Time frame: 6 months, 1 year, 5 years, 7 years and 10 years post-op

    A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best)

  3. Modified Harris Hip Score

    Time frame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op

    A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 100 (best)

  4. EQ-5D-5L

    Time frame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op

    A patient completed functional score to assess quality of life of the patient. Score range: -0.594 (worse) to 1.0 (best).

  5. Radiological Assessment

    Time frame: 1 year, 5 years and 10 years post-op

    Radiographs reviewed for signs of radiolucencies, osteolysis, sclerosis and atrophy around the device

Other outcomes

  1. Adverse Device Effects

    Time frame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op

    Trends and anaylsis or adverse device effects reported

Sponsors and collaborators

Lead sponsor

JRI Orthopaedics

Industry

Registry information

Official study title

A Prospective Single Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System in Spain

Important dates

Study start
2025
Primary completion
2030
Study completion
2036
First posted
Aug 11, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.