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

N/ATerminatedNCT02019433

Aesculap AG5 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Total Hip Arthroplasty Revision

Interventions

Structan®DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Charite Campus Berlin Mitte

Berlin, Germany

Klinik am Eichert

Göppingen, Germany

St. Remigius Krankenhaus Opladen

Leverkusen, Germany

Outcomes

Primary Outcomes

Implant Survival Rates

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

Time frame: 12 months

Secondary Outcomes

Clinical Outcome

Harris Hip Score

Time frame: 3 and 12 months

Pain

Visual Analogue Scale (VAS)

Time frame: 3 and 12 months

Osteolysis

Radiographic Outcome

Time frame: 3 and 12 months

Ossifications

Radiographic Outcome

Time frame: 3 and 12 months

Implant Position

Radiographic Outcome

Time frame: 3 and 12 months

Migration of Structan®

Radiographic Outcome

Time frame: 3 and 12 months

Data from ClinicalTrials.gov

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