Post Market Clinical Follow-Up of Plasmafit® Cup

Active, not recruiting

• Conditions: Total Hip Arthroplasty
• Interventions: Device: Plasmafit® Total Hip Arthroplasty

• Registration Number: NCT02019849
• Lead Sponsor: Aesculap AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-18
• Primary Completion: 2012-10-04
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Plasmafit® Total Hip Arthroplasty	Plasmafit® Total Hip Arthroplasty	-

Primary Outcome Measures

Name	Time	Method
Implant Survival Rates	10 years	Implant survival is analysed at follow-up examinations at 3 months, 12 months, 5 years and 10 years

Secondary Outcome Measures

Name	Time	Method
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
Osteolysis	3 months, 12 months, 5 years, 10 years	Radiological Outcome
Ossifications	3 months, 12 months, 5 years, 10 years	Radiological Outcome

Trial Locations

Locations (2)

Vulpius-Klinik Bad Rappenau; 🇩🇪 Bad Rappenau, Germany

Diakonie-Klinikum Stuttgart; 🇩🇪 Stuttgart, Germany