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

NCT ID: NCT06626490

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2033-03-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aesculap AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henning Windhagen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Orthopädische Kliniken im Annastift, MHH

Locations

Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7

Hanover, , Germany

Countries

Germany

Central Contacts

Kerstin Bergmann

Role: CONTACT

studies@aesculap.de

+49746195- ext. 0

Lutz Dreyer, Dr.

Role: CONTACT

studies@aesculap.de

+49746195- ext. 0

Facility Contacts

Henning Windhagen, Prof. Dr.

Role: primary

Other Identifiers

AAG-O-H-23015

Identifier Type: -

Identifier Source: org_study_id