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OpenTrials
Completed

NCT Number: NCT02019849

Post Market Clinical Follow-Up of Plasmafit® Cup

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

Completed

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Key information

Conditions

Total Hip Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vulpius-Klinik Bad Rappenau, Bad Rappenau, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasmafit® Total Hip Arthroplasty

Device

Primary outcomes

  1. Implant Survival Rates

    Time frame: 10 years

    Implant survival is analysed at follow-up examinations at 3 months, 12 months, 5 years and 10 years

Secondary outcomes

  1. Osteolysis

    Time frame: 3 months, 12 months, 5 years, 10 years

    Radiological Outcome

  2. Ossifications

    Time frame: 3 months, 12 months, 5 years, 10 years

    Radiological Outcome

  3. Implant Position

    Time frame: 3 months, 12 months, 5 years, 10 years

    Radiological Outcome

  4. Migration of Plasmafit®

    Time frame: 3 months, 12 months, 5 years, 10 years

    Radiological Outcome

  5. Clinical Outcome

    Time frame: 3 months, 12 months, 5 years, 10 years

    Harris Hip Score

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2024
First posted
Dec 24, 2013
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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