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NCT02019849 Clinical Trial

Post Market Clinical Follow-Up of Plasmafit® Cup

Total Hip Arthroplasty Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02019849
Other study ID # AAG-O-H-1213
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 18, 2012
Est. completion date June 2024

Study information
Verified date February 2024
Source Aesculap AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date June 2024
Est. primary completion date October 4, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Minimum age 18 years - Indication for cementless total hip arthroplasty - Patient consent for study participation - Physical and mental willingness to participate at clinical and radiological follow-up Exclusion Criteria: - Patient not available for follow-up - Increased anesthetics risks according to the "American Society of Anesthesiology": ASA IV - Tumor - Alcohol or drug abuse - Permanent cortisone therapy - Clinically relevant infection - Pregnancy or planned pregnancy - Prior interventions like osteotomy, fracture treatment or prior THA at the concerned hip - Acute fracture at the concerned hip - Patients needing a cemented hip arthroplasty

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Plasmafit® Total Hip Arthroplasty

Locations
Country Name City State
Germany Vulpius-Klinik Bad Rappenau Bad Rappenau
Germany Diakonie-Klinikum Stuttgart Stuttgart

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 months, 12 months, 5 years and 10 years 10 years
Secondary Osteolysis Radiological Outcome 3 months, 12 months, 5 years, 10 years
Secondary Ossifications Radiological Outcome 3 months, 12 months, 5 years, 10 years
Secondary Implant Position Radiological Outcome 3 months, 12 months, 5 years, 10 years
Secondary Migration of Plasmafit® Radiological Outcome 3 months, 12 months, 5 years, 10 years
Secondary Clinical Outcome Harris Hip Score 3 months, 12 months, 5 years, 10 years
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