NCT04542174

Brief Summary

The intention of this Post Market Clinical Follow-Up study is to obtain mid-term results of the TRJ® endoprosthesis. Aim is to include those patients that have received a TRJ® Total Hip Arthroplasty in 2012 and already did participated in a clinical study taking place in 2014 to obtain 2 years results

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

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

September 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2021

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

September 2, 2020

Last Update Submit

January 13, 2022

Conditions

Arthroplasty, Replacement, HipFollow-Up Study

Keywords

Trochanter retaining joint replacement

Outcome Measures

Primary Outcomes (1)

  • Survival rate of the stem

    The survival of the TRJ® stem prosthesis will be analyzed using the "Kaplan-Meier". Isolated revisions of the inlay and / or of the acetabular components (with the stem being kept in place) are documented, but assessed separately.

    at follow-up examination approximately 8 years after primary intervention

Secondary Outcomes (11)

  • Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)

    at follow-up examination approximately 8 years after primary intervention

  • Harris Hip Score (HHS)

    at follow-up examination approximately 8 years after primary intervention

  • Rate of Adverse and Serious Adverse Events

    at follow-up examination approximately 8 years after primary intervention

  • Pain Assessment

    at follow-up examination approximately 8 years after primary intervention

  • Radiological Outcome: Inlay wear

    at follow-up examination approximately 8 years after primary intervention

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients

You may qualify if:

  • patients have received a TRJ® prosthesis in 2012
  • Patient did participate in the 2 years results evaluation 2014
  • Patient gave his written consent for study participation

You may not qualify if:

  • patient is pregnant
  • patient \< 18 years

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
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 9, 2020

Study Start

September 10, 2020

Primary Completion

September 26, 2021

Study Completion

September 26, 2021

Last Updated

January 14, 2022

Record last verified: 2022-01

Locations

DE(1)