NCT06626490

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Revision Total Hip Arthroplasty
• Periprosthetic Fracture of Hip

Interventions

Type	Name	Description
DEVICE	Prevision Revision hip endoprosthesis stem implantation	The Prevision hip endoprosthetic stem is a femoral part of a hip joint endoprosthesis. The system provides cementless and cemented variants. Prevision hip stems are modular with a short proximal and longer distal component, or monobloc hip stems. Modular components are coupled via a Prevision specific conical connection with a torque wrench and a tension nut to apply a predefined torsional moment on the connection. The distal component of modular Prevision stems can be combined with locking screws for additional bone fixation. Both types, the monobloc and the modular, provide a 12/14 taper that serves as a connection for metal or ceramic prosthesis heads. Prevision hip stems are combined at the acetabulum with a cementless or cemented acetabular cup.

Timeline

• Start date: 2026-05-01
• Primary completion: 2033-03-01
• Completion: 2034-03-01
• First posted: 2024-10-03
• Last updated: 2026-04-13

Locations

1 site across 1 country: Germany