ACE Acetabular Cup UK Multi-centre PMCF Study

Hip Disease Clinical Trial

Official title:

A Prospective UK Multi-Centre Post Market Clinical Follow-up Study of the JRI Orthopaedic ACE Acetabular Cup System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04123431
• Other study ID #: JRI-CS-010
• Status: Not yet recruiting
• Start date: November 2020
• Est. completion date: November 2032

Study information

• Verified date: October 2019
• Source: JRI Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: November 2032
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hip Disease

Intervention

Device:
• Total Hip Replacement
Primary elective total hip replacement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
JRI Orthopaedics

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Device Effects	Trends and anaylsis or adverse device effects reported	6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Primary	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	Implant Survivorship	Implant survivorship based on revision rate and determined using the Kaplan-Meier analysis method	6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Secondary	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)	6 months, 1 year, 5 years, 7 years and 10 years post-op
Secondary	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)	6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Secondary	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).	6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Secondary	Radiological Assessment	Radiographs reviewed for signs of radiolucencies, osteolysis, sclerosis and atrophy around the device	1 year, 5 years and 10 years post-op