ACE Acetabular Cup UK Multi-centre PMCF Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Disease
• Intervention / Treatment: Device: Total Hip Replacement

• Study Type: Observational
• Enrollment (Estimated): 225

Contacts and Locations

Study Locations

• United Kingdom
  • Worthing, United Kingdom, BN11 2DH
    • Recruiting
    • University Hospitals Sussex NHS Foundation Trust
    • Contact: Sarah House; Phone Number: 84196 01903 205111; Email: sarah.house3@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who require elective primary total hip replacement

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ACE Acetabular Cup System with XLPE Liner	Device: Total Hip Replacement; Primary elective total hip replacement
ACE Acetabular Cup System with Ceramic Liner	Device: Total Hip Replacement; Primary elective total hip replacement
ACE Acetabular Cup System with Dual Mobility Insert	Device: Total Hip Replacement; Primary elective total hip replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Hip Score	A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best)	3 years post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survivorship	Implant survivorship based on revision rate and determined using the Kaplan-Meier analysis method	6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Oxford Hip Score	A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 48 (best)	6 months, 1 year, 5 years, 7 years and 10 years post-op
Modified Harris Hip Score	A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 100 (best)	6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
EQ-5D-5L	A patient completed functional score to assess quality of life of the patient. Score range: -0.594 (worse) to 1.0 (best).	6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Radiological Assessment	Radiographs reviewed for signs of radiolucencies, osteolysis, sclerosis and atrophy around the device	1 year, 5 years and 10 years post-op

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Device Effects	Trends and anaylsis or adverse device effects reported	6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op

Collaborators and Investigators

• Sponsor: JRI Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2035

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Total Hip Replacement; Patient reported outcome measures; Post Market Clinical Follow-up / Post Market Surveillance
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Hip
• Other Study ID Numbers: JRI-CS-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No