Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®

January 25, 2017 updated by: Aesculap AG
Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment Structan®

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite Campus Berlin Mitte
      • Göppingen, Germany, 73035
        • Klinik am Eichert
      • Leverkusen, Germany, 51379
        • St. Remigius Krankenhaus Opladen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

specialist clinical centre

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Structan®
Device: Structan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survival Rates
Time Frame: 12 months
Implant survival is analysed at follow-up examinations at 3 and 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome
Time Frame: 3 and 12 months
Harris Hip Score
3 and 12 months
Pain
Time Frame: 3 and 12 months
Visual Analogue Scale (VAS)
3 and 12 months
Osteolysis
Time Frame: 3 and 12 months
Radiographic Outcome
3 and 12 months
Ossifications
Time Frame: 3 and 12 months
Radiographic Outcome
3 and 12 months
Implant Position
Time Frame: 3 and 12 months
Radiographic Outcome
3 and 12 months
Migration of Structan®
Time Frame: 3 and 12 months
Radiographic Outcome
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAG-O-H-1212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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