Actively Recruiting
A Prospective UK Multi-Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System
Led by JRI Orthopaedics · Updated on 2025-09-03
225
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term outcomes of the ACE Acetabular Cup System, a device used in total hip replacement surgery. This procedure replaces both the hip ball and socket to relieve pain and help patients return to normal activities. The study aims to monitor the safety and performance of this CE-marked device over 10 years by assessing clinical, functional, and radiological results in patients with hip disease. The ACE Acetabular Cup System offers three options for socket liners: ceramic, polymer, or dual mobility, allowing surgeons to choose the best fit for each patient. Participants in the study have received a primary elective total hip replacement using this system combined with a JRI femoral stem and head. The study is observational and follows patients over a decade to gather data on device function and patient health. Participants will be followed through questionnaires, reviews of X-rays, and monitoring of any complications. Key measurements include the Oxford Hip Score at 3 years post-operation, along with implant survivorship and other hip function assessments at multiple time points up to 10 years. Radiological assessments will also be conducted at 1, 5, and 10 years. This comprehensive follow-up helps researchers understand how well the device performs long-term and supports patient safety.
CONDITIONS
Brief Title
ACE Acetabular Cup UK Multi-centre PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients deemed suitable for elective primary total hip replacement as per device instructions
- Male or female patients aged 18 years or older
You will not qualify if you...
- Patients unable to provide written informed consent
- Patients unsuitable for total hip replacement based on device contraindications
- Patients needing total hip replacement due to trauma such as neck of femur fracture
- Pregnant patients
- Patients receiving implants other than the approved ACE Acetabular Cup System with JRI femoral stem and head
- Patients unable to comply with the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery plus initial hospital stay
Participants undergo elective primary total hip replacement using the ACE Acetabular Cup System and receive immediate post-operative care.
1 surgical visit and hospital stay
Duration - Up to 10 years post-operation
Participants are followed up to assess implant survivorship, hip function scores, quality of life, and radiological outcomes at multiple time points after surgery.
Visits at 6 months, 1 year, 3 years, 5 years, 7 years, and 10 years post-operation
Trial Site Locations
Total: 1 location
1
University Hospitals Sussex NHS Foundation Trust
Worthing, United Kingdom, BN11 2DH
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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