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

All 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 2017.
Information provided to ClinicalTrials.gov by Aesculap AG.