Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAesculap AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Revision hip arthroplasty patients treated with a Prevision hip stem
Written patient informed consent
Patients are able to attend at follow-up examinations
Disqualifiers
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
Trial population
Patients with indication of a hip revision
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Prevision Revision hip endoprosthesis stem implantation
DeviceThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Functional outcome of the hip revision surgery
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)
Time frame
after two yearsSecondary outcomes
1
Kaplan-Meier survival
Kaplan-Meier Analysis is a standard statistical method to describe the survival of human subjects or medical products over a defined time period. The revision-free survival rate is the performance indicator of the product under investigation and confirms the clinical outcome of the knee prosthesis. Information on survival of the implant will be collected until the last follow-up of the study patients took place. 1. revision for any reason 2. hip stem revision 3. aseptic hip stem revision
Time frame
after two years2
EQ-5D-5L Quality of Life
EQ-5D is a standardized 5-dimension 5-level measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level "the worst health you can imagine" to "the best health you can imagine".
Time frame
visits after 2 and 5 years3
Complications
Time frame
visits after 2 and 5 years4
Patient satisfaction
Patient reported four-scale evaluation: * very satisfied * satisfied * unsatisfied * very unsatisfied
Time frame
visits after 2 and 5 yearsSponsors and contacts
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Source ClinicalTrials.gov