Overview

This trial is active, not recruiting.

Condition total hip arthroplasty
Treatment plasmafit® total hip arthroplasty
Sponsor Aesculap AG
Start date January 2012
End date December 2012
Trial size 100 participants
Trial identifier NCT02019849, AAG-O-H-1213

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
plasmafit® total hip arthroplasty

Primary Outcomes

Measure
Implant Survival Rates
time frame: 10 years

Secondary Outcomes

Measure
Osteolysis
time frame: 3 months, 12 months, 5 years, 10 years
Ossifications
time frame: 3 months, 12 months, 5 years, 10 years
Implant Position
time frame: 3 months, 12 months, 5 years, 10 years
Migration of Plasmafit®
time frame: 3 months, 12 months, 5 years, 10 years
Clinical Outcome
time frame: 3 months, 12 months, 5 years, 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Aesculap AG.