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NCT02019433 Clinical Trial

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

Total Hip Arthroplasty Revision Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02019433
Other study ID # AAG-O-H-1212
Secondary ID
Status Terminated
Phase N/A
First received December 5, 2013
Last updated January 25, 2017
Start date July 2012
Est. completion date December 2014

Study information
Verified date January 2017
Source Aesculap AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date December 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Structan®

Locations
Country Name City State
Germany Charite Campus Berlin Mitte Berlin
Germany Klinik am Eichert Göppingen
Germany St. Remigius Krankenhaus Opladen Leverkusen

Sponsors (1)
Lead Sponsor Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Implant Survival Rates Implant survival is analysed at follow-up examinations at 3 and 12 months 12 months
Secondary Clinical Outcome Harris Hip Score 3 and 12 months
Secondary Pain Visual Analogue Scale (VAS) 3 and 12 months
Secondary Osteolysis Radiographic Outcome 3 and 12 months
Secondary Ossifications Radiographic Outcome 3 and 12 months
Secondary Implant Position Radiographic Outcome 3 and 12 months
Secondary Migration of Structan® Radiographic Outcome 3 and 12 months