ACE Acetabular Cup UK Multi-centre PMCF Study

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

Patrocinadores

Patrocinador principal: JRI Orthopaedics

Fuente JRI Orthopaedics
Resumen breve

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.

Estado general Not yet recruiting
Fecha de inicio November 2020
Fecha de Terminación November 2032
Fecha de finalización primaria November 2025
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Oxford Hip Score 3 years post-op
Resultado secundario
Medida Periodo de tiempo
Implant Survivorship 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Oxford Hip Score 6 months, 1 year, 5 years, 7 years and 10 years post-op
Modified Harris Hip Score 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
EQ-5D-5L 6 months, 1 year, 3 years, 5 years, 7 years and 10 years post-op
Radiological Assessment 1 year, 5 years and 10 years post-op
Inscripción 225
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Total Hip Replacement

Descripción: Primary elective total hip replacement

Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Fecha de verificación

October 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Grupo de brazo

Etiqueta: ACE Acetabular Cup System with XLPE Liner

Etiqueta: ACE Acetabular Cup System with Ceramic Liner

Etiqueta: ACE Acetabular Cup System with Dual Mobility Insert

Datos del paciente No
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov