NCT02019862

Brief Summary

Clinical and radiological 2 years results of TRJ® Hip Stem.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

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

First Submitted

Initial submission to the registry

December 4, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1.1 years

First QC Date

December 4, 2013

Last Update Submit

April 15, 2015

Conditions

Total Hip Arthroplasty

Keywords

Total hip arthroplastyTRJPMCFHip stem

Outcome Measures

Primary Outcomes (1)

  • Implant Survival

    24 months

Secondary Outcomes (5)

  • Clinical Outcome

    24 months

  • Osteolysis

    24 months

  • Ossification

    24 months

  • Migration

    24 months

  • TRJ® Implant Position

    24 months

Study Arms (1)

TRJ®

Device: TRJ® Total Hip Arthroplasty

Interventions

TRJ® Total Hip ArthroplastyDEVICE
TRJ®

Eligibility Criteria

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

specialist clinical centre

You may qualify if:

  • TRJ® implantation performed
  • patient consent available for participation in the study

You may not qualify if:

  • permanent cortisone therapy
  • alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dreifaltigkeitskrankenhaus Köln

Cologne, 50933, Germany

Location

Study Design

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

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 24, 2013

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

DE(1)