Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants (PREMO)

Aesculap

Status: Not yet enrolling

Conditions: Periprosthetic Fracture of Hip; Revision Total Hip Arthroplasty

Treatments: Device: Prevision Revision hip endoprosthesis stem implantation

Study type: Observational

Funder types: Industry

Identifiers

NCT06626490

AAG-O-H-23015

Details and patient eligibility

About

The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem. The study is an observational post-market clinical follow-up study, and the study sites chose the stem variant depending on their own routine and indication.

Full description

Generally, the advantage of the Prevision implant family is that all implant variants can be implanted with basically the same instrumentation, which makes it easier to switch to another variant. All implant variants will be available at the study sites and switching between the variants in the study will be encouraged.

The aim of the study is to prove the non-inferiority of the OHS functional outcome after two years to the predecessor implant generation, and comparable revision hip stems. In addition, the patient groups treated with the different variants, and outcome of these subgroups will be descriptively compared.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Revision hip arthroplasty patients treated with a Prevision hip stem
• Written patient informed consent
• Patients are able to attend at follow-up examinations

Exclusion criteria

• Patients < 18 years at surgery
• Pregnancy at implantation
• Patients held in a custodial setting
• Patients in a relationship of dependence on the sponsor, the clinic or the investigator