Prevision® PMCF Study

Post Market Clinical Follow-Up Study Prevision®

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.

Study Overview

• Status: Completed
• Conditions: Survival, Prosthesis
• Intervention / Treatment: Device: Prevision®

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Germany
  • Bad Hersfeld, Germany, 36251
    • Klinikum Bad Hersfeld

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving a Prevision® stem between 2002 and 2012

Description

Inclusion:

• Patient received a Prevision® Hip Stem (curved or straight) between 2002 an 2012
• Patient gave his written consent for study participation

Exclusion:

- none

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aesculap AG

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: survival; hip arthroplasty; revision arthroplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: AAG-O-H-1508

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No