Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®
Terminated
- Conditions
- Total Hip Arthroplasty Revision
- Interventions
- Device: Structan®
- Registration Number
- NCT02019433
- Lead Sponsor
- Aesculap AG
- Brief Summary
Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment Structan®
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Structan® Structan® -
- Primary Outcome Measures
Name Time Method Implant Survival Rates 12 months Implant survival is analysed at follow-up examinations at 3 and 12 months
- Secondary Outcome Measures
Name Time Method Pain 3 and 12 months Visual Analogue Scale (VAS)
Implant Position 3 and 12 months Radiographic Outcome
Osteolysis 3 and 12 months Radiographic Outcome
Ossifications 3 and 12 months Radiographic Outcome
Clinical Outcome 3 and 12 months Harris Hip Score
Migration of Structan® 3 and 12 months Radiographic Outcome
Trial Locations
- Locations (3)
Charite Campus Berlin Mitte
🇩🇪Berlin, Germany
Klinik am Eichert
🇩🇪Göppingen, Germany
St. Remigius Krankenhaus Opladen
🇩🇪Leverkusen, Germany