NCT02019433

Brief Summary

Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment Structan®

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

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

July 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

December 5, 2013

Last Update Submit

January 25, 2017

Conditions

Total Hip Arthroplasty Revision

Keywords

THA, augment, revision, pelvis

Outcome Measures

Primary Outcomes (1)

  • Implant Survival Rates

    Implant survival is analysed at follow-up examinations at 3 and 12 months

    12 months

Secondary Outcomes (6)

  • Clinical Outcome

    3 and 12 months

  • Pain

    3 and 12 months

  • Osteolysis

    3 and 12 months

  • Ossifications

    3 and 12 months

  • Implant Position

    3 and 12 months

  • +1 more secondary outcomes

Study Arms (1)

Structan®

Device: Structan®

Interventions

Structan®DEVICE
Structan®

Eligibility Criteria

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

specialist clinical centre

You may qualify if:

  • Minimum age 18 years
  • Indication for cementless hip arthroplasty with acetabular defects that need Allograft or titanium augment
  • Patient consent for study participation
  • Physical and mental willingness to participate in the follow-ups

You may not qualify if:

  • Patient not available for follow-up
  • Increased anesthetics risks for the patient according to the "American Society of Anesthesiology": ASA IV
  • Tumor
  • Alcohol- or Drug abuse
  • Permanent cortisone therapy
  • Clinically relevant infection
  • (Planned) pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Charite Campus Berlin Mitte

Berlin, 10117, Germany

Location

Klinik am Eichert

Göppingen, 73035, Germany

Location

St. Remigius Krankenhaus Opladen

Leverkusen, 51379, Germany

Location

Study Design

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

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 24, 2013

Study Start

July 1, 2012

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

DE(3)