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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-16

Study Completion Date

2024-03-24

Brief Summary

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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.

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Detailed Description

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The study's main purpose is the collection of clinical data on the safety and performance of the Columbus® Revision Knee endoprosthesis

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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navigation assisted knee revision surgery

Navigated Revision Total Knee Arthroplasty

Intervention Type DEVICE

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

manual procedure

Manual Revision Total Knee Arthroplasty

Intervention Type DEVICE

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

Interventions

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Navigated Revision Total Knee Arthroplasty

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient underwent navigated revision surgery using the Columbus® Revision knee prosthesis (case group)
* Patient underwent conventional manual revision surgery using another implant system (control group)
* Written informed consent