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NCT Number: NCT04123431

ACE Acetabular Cup UK Multi-centre PMCF Study

A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, and involves replacing both the hip ball and socket. Its goal is to provide pain relief, allowing the person to return to a normal lifestyle. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has a H-A.C. coating to promote ossoeintegration of the device within the host bone. To increase the surgeons choice and thus suitability for the patient, there is the option of 3 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 devices 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 is done by examining patient outcomes through questionnaires, reviews of X-rays and complications by patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.

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Key information

Conditions

Hip Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Sussex NHS Foundation Trust

Worthing, BN11 2DH, United Kingdom

Location status: Recruiting

Location contact

Sarah House

CONTACT

[email protected]

01903 205111 ext. 84196

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 or older.

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 UK Multi-Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System

Important dates

Study start
2023
Primary completion
2029
Study completion
2035
First posted
Oct 11, 2019
Registry last updated
Sep 3, 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.

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