Prevision® PMCF Study

Survival, Prosthesis Clinical Trial

Official title:

Post Market Clinical Follow-Up Study Prevision®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510065
• Other study ID #: AAG-O-H-1508
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: April 2018
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion:

• Patient received a Prevision® Hip Stem (curved or straight) between 2002 an 2012

• Patient gave his written consent for study participation

Exclusion:

• none

Related Conditions & MeSH terms

• Prosthesis Failure
• Survival, Prosthesis

Intervention

Device:
• Prevision®
One time Evaluation with documentation of one follow-up visit

Locations

Country	Name	City	State
Germany	Klinikum Bad Hersfeld	Bad Hersfeld

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevision® survival	Kaplan Meier Survival Rate, retrospective Analysis of Patients operated between 2002 and 2012	4-14 years after implantation
Secondary	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
Secondary	Ectopic Ossification	Radiological Results, Ectopic Ossification acc. to Brooker; retrospective Analysis of Patients operated between 2002 and 2012	4-14 years after implantation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse Events	Documentation of any Adverse event	4-14 years after implantation
Secondary	Serious Adverse Events	Documentation of any Serious Adverse event	4-14 years after implantation