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Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration

NCT02615522 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 124

Last updated 2022-04-20

No results posted yet for this study

Summary

Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark.

200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. Documentation of clinical and radiological parameters within the clinical routine pre-operative and post-operative at 3 and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee functionality, mobility and stability.

Conditions

  • Osteoarthritis, Knee
  • Joint Instability

Interventions

DEVICE

BPK-S Integration

Sponsors & Collaborators

  • Peter Brehm GmbH

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Austria

Study Locations

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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 NCT02615522 on ClinicalTrials.gov