Post Market Clinical Follow-Up of Plasmafit® Cup

February 20, 2024 updated by: Aesculap AG
Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Rappenau, Germany
        • Vulpius-Klinik Bad Rappenau
      • Stuttgart, Germany
        • Diakonie-Klinikum Stuttgart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Specialist Clinical Centre

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Plasmafit® Total Hip Arthroplasty
Device: Plasmafit® Total Hip Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteolysis
Time Frame: 3 months, 12 months, 5 years, 10 years
Radiological Outcome
3 months, 12 months, 5 years, 10 years
Ossifications
Time Frame: 3 months, 12 months, 5 years, 10 years
Radiological Outcome
3 months, 12 months, 5 years, 10 years
Implant Position
Time Frame: 3 months, 12 months, 5 years, 10 years
Radiological Outcome
3 months, 12 months, 5 years, 10 years
Migration of Plasmafit®
Time Frame: 3 months, 12 months, 5 years, 10 years
Radiological Outcome
3 months, 12 months, 5 years, 10 years
Clinical Outcome
Time Frame: 3 months, 12 months, 5 years, 10 years
Harris Hip Score
3 months, 12 months, 5 years, 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2012

Primary Completion (Actual)

October 4, 2012

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimated)

December 24, 2013

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAG-O-H-1213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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