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Post Market Clinical Follow-Up of Plasmafit® Cup

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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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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