ACE Acetabular Cup UK Multi-centre PMCF Study

Not yet recruiting

• Conditions: Hip Disease
• Interventions: Device: Total Hip Replacement

• Registration Number: NCT04123431
• Lead Sponsor: JRI Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-11
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28
• Study Start: 2020-11
• Primary Completion: 2025-11
• Study Completion: 2032-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 225

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 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACE Acetabular Cup System with Ceramic Liner	Total Hip Replacement	-
ACE Acetabular Cup System with Dual Mobility Insert	Total Hip Replacement	-
ACE Acetabular Cup System with XLPE Liner	Total Hip Replacement	-

Primary Outcome Measures

Name	Time	Method
Oxford Hip Score	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 Outcome Measures

Name	Time	Method
Radiological Assessment	1 year, 5 years and 10 years post-op	Radiographs reviewed for signs of radiolucencies, osteolysis, sclerosis and atrophy around the device
Oxford Hip Score	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)
Modified Harris Hip Score	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)
EQ-5D-5L	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).
Implant Survivorship	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