ACE Acetabular Cup Spanish PMCF Study

NCT07115732 | Not Yet Recruiting

• 1 other identifier: JRI-CS-011
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Disease

Keywords

Total Hip Replacement; Patient reported outcome measures; Post 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 (2)

ACE Acetabular Cup System with XLPE Liner

Device: Total Hip Replacement

ACE Acetabular Cup System with Ceramic Liner

Device: Total Hip Replacement

Interventions

Total Hip Replacement DEVICE

Primary elective total hip replacement

ACE Acetabular Cup System with Ceramic Liner; ACE Acetabular Cup System with XLPE Liner

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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 to 85 years.

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.

Sponsors & Collaborators

• JRI Orthopaedics: lead

Study Sites (1)

Hospital General de Granollers

Barcelona, Catalonia, 08402, Spain

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

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

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): July 1, 2036
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)