ACE Acetabular Cup Spanish PMCF Study
ConditionHip Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorJRI Orthopaedics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients deemed suitable for elective primary THR, as per indications in the IFU.
Male or female, 18 years to 85 years.
Disqualifiers
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 who are pregnant (exclusion criteria for THR in general).
Trial population
Patients who require elective primary total hip replacement
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Total Hip Replacement
DevicePrimary elective total hip replacement
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: ACE Acetabular Cup System with XLPE Liner1 intervention
Group B: ACE Acetabular Cup System with Ceramic Liner1 intervention
Trial outcomes
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)
Time frame
3 years post-opSecondary outcomes
1
Implant Survivorship
Implant survivorship based on revision rate and determined using the Kaplan-Meier analysis method
Time frame
6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op2
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)
Time frame
6 months, 1 year, 5 years, 7 years and 10 years post-op3
Modified Harris Hip Score
A patient completed functional score to assess pain and function of the affected hip joint. Score range: 0 (worse) to 100 (best)
Time frame
6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op4
EQ-5D-5L
A patient completed functional score to assess quality of life of the patient. Score range: -0.594 (worse) to 1.0 (best).
Time frame
6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-opOther outcomes
1
Adverse Device Effects
Trends and anaylsis or adverse device effects reported
Time frame
6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-opSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: