Periprosthetic Fracture of Hip, Revision Total Hip Arthroplasty
Conditions
Keywords
Patient-reported outcomes, Clinical performance and safety, Total hip arthroplasty implantation
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.
Interventions
DEVICEPrevision 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 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.
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome of the hip revision surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier survival | after two years | 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 |
| EQ-5D-5L Quality of Life | visits after 2 and 5 years | 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". |
| Complications | visits after 2 and 5 years | — |
| Patient satisfaction | visits after 2 and 5 years | Patient reported four-scale evaluation: * very satisfied * satisfied * unsatisfied * very unsatisfied |
| Pain (VAS Score) | visits after 2 and 5 years | 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 |
| Radiology: Hip stem subsidence | visits after 2 and 5 years | Hip stem subsidence in mm. |
| Qualitative radiologic assessment | visits after 2 and 5 years | Fracture healing; if radiolucent line \> 2 mm, resorption, hypertrophy, cyst |
Countries
Germany, United Kingdom
Contacts
CONTACTKerstin Bergmann
CONTACTLutz Dreyer, Dr.
PRINCIPAL_INVESTIGATORHenning Windhagen, Prof. Dr.
Orthopädische Kliniken im Annastift, MHH
Outcome results
None listed