Post Market Clinical Follow-Up of Plasmafit® Cup

Aesculap

Status: Active, not recruiting

Conditions: Total Hip Arthroplasty

Treatments: Device: Plasmafit® Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT02019849

AAG-O-H-1213

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Plasmafit® Total Hip Arthroplasty

Treatment:

Device: Plasmafit® Total Hip Arthroplasty