NCT03510065

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

April 17, 2018

Last Update Submit

April 27, 2018

Conditions

Survival, Prosthesis

Keywords

hip arthroplastyrevision arthroplastysurvival

Outcome Measures

Primary Outcomes (1)

  • Prevision® survival

    Kaplan Meier Survival Rate, retrospective Analysis of Patients operated between 2002 and 2012

    4-14 years after implantation

Secondary Outcomes (8)

  • Clinical Results

    4-14 years after implantation

  • Ectopic Ossification

    4-14 years after implantation

  • Sinking / Migration of the Stem

    4-14 years after implantation

  • Radiological Evaluation of the Stem

    4-14 years after implantation

  • Quality of Life

    4-14 years after implantation

  • +3 more secondary outcomes

Interventions

Prevision®DEVICE

One time Evaluation with documentation of one follow-up visit

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving a Prevision® stem between 2002 and 2012

You may qualify if:

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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Bad Hersfeld

Bad Hersfeld, 36251, Germany

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 27, 2018

Study Start

January 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

April 30, 2018

Record last verified: 2018-04

Locations

DE(1)