An observational study in Revision Total Hip Arthroplasty and Periprosthetic Fracture of Hip, sponsored by Aesculap AG. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Aesculap AG · Observational
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.
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.
Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with indication of a hip revision
Exclusion Criteria:
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.
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 years
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 years
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 years
Complications
Time frame: visits after 2 and 5 years
Patient satisfaction
Patient reported four-scale evaluation: * very satisfied * satisfied * unsatisfied * very unsatisfied
Time frame: visits after 2 and 5 years
Pain (VAS Score)
VAS Pain at Rest: 0-100, lower is better VAS Pain under load: 0-100, lower is better Patients are asked to mark a point on the line that corresponds to their current level of pain. This mark is then measured and converted into a numerical value, usually between 0 and 10 or 0 and 100, where 0 indicates no pain and the highest value indicates the most severe pain
Time frame: visits after 2 and 5 years
Radiology: Hip stem subsidence
Hip stem subsidence in mm.
Time frame: visits after 2 and 5 years
Qualitative radiologic assessment
Fracture healing; if radiolucent line \> 2 mm, resorption, hypertrophy, cyst
Time frame: visits after 2 and 5 years
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