NCT04123431

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
115mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Jun 2023Nov 2035

First Submitted

Initial submission to the registry

October 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
3.7 years until next milestone

Study Start

First participant enrolled

June 6, 2023

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2029

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2035

Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

6.4 years

First QC Date

October 9, 2019

Last Update Submit

August 26, 2025

Conditions

Hip Disease

Keywords

Total Hip ReplacementPatient reported outcome measuresPost Market Clinical Follow-up / Post Market Surveillance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Implant Survivorship

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

  • Oxford Hip Score

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

  • Modified Harris Hip Score

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

  • EQ-5D-5L

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

  • Radiological Assessment

    1 year, 5 years and 10 years post-op

Other Outcomes (1)

  • Adverse Device Effects

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

Study Arms (3)

ACE Acetabular Cup System with XLPE Liner

Device: Total Hip Replacement

ACE Acetabular Cup System with Ceramic Liner

Device: Total Hip Replacement

ACE Acetabular Cup System with Dual Mobility Insert

Device: Total Hip Replacement

Interventions

Total Hip ReplacementDEVICE

Primary elective total hip replacement

ACE Acetabular Cup System with Ceramic LinerACE Acetabular Cup System with Dual Mobility InsertACE Acetabular Cup System with XLPE Liner

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who require elective primary total hip replacement

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Sussex NHS Foundation Trust

Worthing, BN11 2DH, United Kingdom

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 11, 2019

Study Start

June 6, 2023

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2035

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)