Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prevision Revision hip endoprosthesis stem implantation.
- Who it may be relevant to
- Registry conditions: Revision Total Hip Arthroplasty, Periprosthetic Fracture of Hip. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Interventions
- 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 scre
Primary outcome measures
- Functional outcome of the hip revision surgery [Time frame: after two years]
Secondary outcome measures (7)
- Kaplan-Meier survival [Time frame: after two years]
- EQ-5D-5L Quality of Life [Time frame: visits after 2 and 5 years]
- Complications [Time frame: visits after 2 and 5 years]
- Patient satisfaction [Time frame: visits after 2 and 5 years]
- Pain (VAS Score) [Time frame: visits after 2 and 5 years]
- Radiology: Hip stem subsidence [Time frame: visits after 2 and 5 years]
- Qualitative radiologic assessment [Time frame: visits after 2 and 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7 — Hanover
United Kingdom · 1 center
- Hinchingbrooke Hospital — Huntingdon
Identifiers
NCT: NCT06626490 · AAG-O-H-23015