Prevision® PMCF Study

Study Overview
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Brief Summary
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Monocentric, non-interventional Post-Market Clinical Follow-Up (PMCF) Study on past implantations of the Prevision® prosthesis; the survival rate of the Prevision® prosthesis shall be evaluated and compared to literature results on comparable Revision stems.

Official Title
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Post Market Clinical Follow-Up Study Prevision®

Conditions
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Survival, Prosthesis

Intervention / Treatment
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* Device: Prevision®


Participation Criteria
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Eligibility Criteria
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Inclusion: Patient received a Prevision® Hip Stem (curved or straight) between 2002 an 2012 Patient gave his written consent for study participation Exclusion: - none
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Prevision®|One time Evaluation with documentation of one follow-up visit|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevision® survival | Kaplan Meier Survival Rate, retrospective Analysis of Patients operated between 2002 and 2012 | 4-14 years after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Results | Harris Hip Score: The score covers pain, function, absence of deformity, and range of motion. Pain is measured as pain severity and its effect on activities and need for pain medication. Hip function score consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). | 4-14 years after implantation | 
| Ectopic Ossification | Radiological Results, Ectopic Ossification acc. to Brooker; retrospective Analysis of Patients operated between 2002 and 2012 | 4-14 years after implantation | 
| Sinking / Migration of the Stem | Radiological Results, Sinking / Migration of the Stem in [mm], Comparison to x-ray at Hospital discharge where available, retrospective Analysis of Patients operated between 2002 and 2012 | 4-14 years after implantation | 
| Radiological Evaluation of the Stem | Radiological Results of Radiolucent Lines, Osteolysis, Hypertrophy, Decrease of corticalis thickness, Cyst; retrospective Analysis of Patients operated between 2002 and 2012 | 4-14 years after implantation | 
| Quality of Life | Measured by EQ-5D-5L: The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects, as compared to the EQ-5D-3L. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | 4-14 years after implantation | 
| Pain | Pain in the hip Joint, measured by Visual Analogue Scale: The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. | 4-14 years after implantation | 
| Adverse Events | Documentation of any Adverse event | 4-14 years after implantation | 
| Serious Adverse Events | Documentation of any Serious Adverse event | 4-14 years after implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip arthroplasty, revision arthroplasty, survival