Clinical trial NCT04123431: ACE Acetabular Cup UK Multi-centre PMCF Study
Official title: A Prospective UK Multi-Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hip Disease
Keywords: Total Hip Replacement
Patient reported outcome measures
Post Market Clinical Follow-up / Post Market Surveillance
Lead sponsor: JRI Orthopaedics
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who require elective primary total hip replacement

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Oxford Hip Score
timeFrame: 3 years post-op
Secondary outcomes:
measure: Implant Survivorship
timeFrame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
measure: Oxford Hip Score
timeFrame: 6 months, 1 year, 5 years, 7 years and 10 years post-op
measure: Modified Harris Hip Score
timeFrame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
measure: EQ-5D-5L
timeFrame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
measure: Radiological Assessment
timeFrame: 1 year, 5 years and 10 years post-op
Other outcomes:
measure: Adverse Device Effects
timeFrame: 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Locations:
Study officials:
References: