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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevision Revision hip endoprosthesis stem implantation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | after two years |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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Inclusion Criteria:
Exclusion Criteria:
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Patients with indication of a hip revision
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kerstin Bergmann | Contact | +49746195- | 0 | studies@aesculap.de |
| Lutz Dreyer, Dr. | Contact | +49746195- | 0 | studies@aesculap.de |
| Name | Affiliation | Role |
|---|---|---|
| Henning Windhagen, Prof. Dr. | Orthopädische Kliniken im Annastift, MHH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7 | Recruiting | Hanover | 30625 | Germany |
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| 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". | visits after 2 and 5 years |
| Complications | visits after 2 and 5 years |
| Patient satisfaction | Patient reported four-scale evaluation:
| 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 | visits after 2 and 5 years |
| Radiology: Hip stem subsidence | Hip stem subsidence in mm. | visits after 2 and 5 years |
| Qualitative radiologic assessment | Fracture healing; if radiolucent line > 2 mm, resorption, hypertrophy, cyst | visits after 2 and 5 years |
| Hinchingbrooke Hospital | Recruiting | Huntingdon | Cambridgeshire | PE29 6NT | United Kingdom |
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