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Recruiting NCT06626490

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

Conditions: Revision Total Hip Arthroplasty Periprosthetic Fracture of Hip

Sponsor: Aesculap AG

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
Prevision Revision hip endoprosthesis stem implantation
DEVICE
Locations 1
Germany (1)
Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7
Hanover
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.04.2026
Completion date
01.03.2034
Registry ID
NCT06626490
Source
clinicaltrials.gov
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