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COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients

NCT05113303 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-08-14

No results posted yet for this study

Summary

The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations or treatment measures. The treatment will be carried out exclusively according to medical standards. The study therefore only serves the purpose of observing this standard-compliant treatment and specifically documenting it scientifically.

Conditions

  • Knee Osteoarthritis
  • Bone; Deformity, Congenital
  • Prosthesis Failure
  • Prosthesis-Related Infections

Interventions

DEVICE

Navigated Revision Total Knee Arthroplasty

Patients in the case group receive a Columbus® Revision knee prosthesis, implanted with computer assisted surgery

DEVICE

Manual Revision Total Knee Arthroplasty

Patients in the control group will correspond to a historical cohort of patients in which manual jig-assisted knee revision was done.

Sponsors & Collaborators

  • B.Braun Surgical SA

    collaborator INDUSTRY

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Emilio Larrazabal Raluy, MD · Hospital Universitario Cruces, Spain

  • Igor Gonzales, MD · Hospital Universitario Cruces, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2023-06-16
Completion
2024-03-24

Countries

  • Spain

Study Locations

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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 NCT05113303 on ClinicalTrials.gov