Total Hip Arthroplasty
Conditions
Keywords
THA, Plasmafit®
Brief summary
Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.
Interventions
DEVICEPlasmafit® Total Hip Arthroplasty
Sponsors
Aesculap AG
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survival Rates | 10 years | Implant survival is analysed at follow-up examinations at 3 months, 12 months, 5 years and 10 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Osteolysis | 3 months, 12 months, 5 years, 10 years | Radiological Outcome |
| Ossifications | 3 months, 12 months, 5 years, 10 years | Radiological Outcome |
| Implant Position | 3 months, 12 months, 5 years, 10 years | Radiological Outcome |
| Migration of Plasmafit® | 3 months, 12 months, 5 years, 10 years | Radiological Outcome |
| Clinical Outcome | 3 months, 12 months, 5 years, 10 years | Harris Hip Score |
Countries
Germany
Outcome results
None listed