Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Revision Total Hip Arthroplasty
- Sponsor
- Aesculap AG
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Functional outcome of the hip revision surgery
- Status
- Recruiting
- Last Updated
- 9 days ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Functional outcome of the hip revision surgery
Time Frame: after two years
Oxford Hip Score:The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure designed to assess disability in patients undergoing total hip replacement (THR)
Secondary Outcomes
- Kaplan-Meier survival(after two years)
- EQ-5D-5L Quality of Life(visits after 2 and 5 years)
- Complications(visits after 2 and 5 years)
- Patient satisfaction(visits after 2 and 5 years)
- Pain (VAS Score)(visits after 2 and 5 years)
- Radiology: Hip stem subsidence(visits after 2 and 5 years)
- Qualitative radiologic assessment(visits after 2 and 5 years)