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Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr or Ceramic

NCT03293719 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2019-11-19

No results posted yet for this study

Summary

Prospective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for 5 years after implantation or until revision of the prosthesis, whichever occurs first. Demographic data will be collected together with data regarding safety and benefit at defined timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after implantation).

Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.

Conditions

  • Osteoarthritis
  • Osteoarthritis, Knee
  • Joint Instability
  • Arthritis
  • Joint Disease
  • Musculoskeletal Disease
  • Rheumatic Diseases

Interventions

DEVICE

BPK-S Integration UC

Primary Knee Endoprosthesis

Sponsors & Collaborators

  • P.R.I.S.M.A.-CRO

    collaborator UNKNOWN

  • Peter Brehm GmbH

    lead INDUSTRY

Principal Investigators

  • Christian E. Berger, Prof. · Sozialmedizinisches Zentrum Ost - Donauspital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2019-10-14
Completion
2019-10-14

Countries

  • Austria

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03293719 on ClinicalTrials.gov