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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02019433
Enrollment
5
Registered
2013-12-24
Start date
2012-07-31
Completion date
2014-12-31
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Hip Arthroplasty Revision

Keywords

THA, augment, revision, pelvis

Brief summary

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

Interventions

DEVICEStructan®

Sponsors

Aesculap AG
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Implant Survival Rates12 monthsImplant survival is analysed at follow-up examinations at 3 and 12 months

Secondary

MeasureTime frameDescription
Pain3 and 12 monthsVisual Analogue Scale (VAS)
Osteolysis3 and 12 monthsRadiographic Outcome
Clinical Outcome3 and 12 monthsHarris Hip Score
Implant Position3 and 12 monthsRadiographic Outcome
Migration of Structan®3 and 12 monthsRadiographic Outcome
Ossifications3 and 12 monthsRadiographic Outcome

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026