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

Comparative, Case Control, Mono-center PMCF Study on Manual and Navigated Revision Knee Patients After a Minimum Follow-Up of Two Years

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Prosthesis-Related Infections; Prosthesis Failure; Bone; Deformity, Congenital
• Intervention / Treatment: Device: Navigated Revision Total Knee Arthroplasty; Device: Manual Revision Total Knee Arthroplasty

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Spain
  • Bizkaia
    • Barakaldo, Bizkaia, Spain, 48903
      • Hospital Universitario Cruces

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients in the case group will be recruited consecutively. No selection besides the inclusion and exclusion criteria will take place. The following criteria are applicable for the inclusion of study patients:

Patients in the control group will correspond to a historical cohort of patients in which manual jig-assisted knee revision was done. A minimum of two years follow up will be necessary to be included.

Description

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

Exclusion Criteria:

• Pregnancy
• Patient Age at time of revision surgery < 18 years
• Allergy to any prosthesis component

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
navigation assisted knee revision surgery	Device: Navigated Revision Total Knee Arthroplasty; Patients in the case group receive a Columbus® Revision knee prosthesis, implanted with computer assisted surgery
manual procedure	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the final joint line height between groups after the surgical restoration of native joint line height of revision implants	Joint line height will be assessed using the systematic, comparative x-ray analysis	Comparison of final joint line height before the surgery with height at the 3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of Hip knee Ankle Angle	The HKA within 3 degrees of neutral has been used as the essential outcome measure in TKA.	Comparison of HKA before the surgery with HKA at 3 months and 2 years follow-up
Forgotten Joint Score	The FJS Knee was designed to assess patient outcome in patients undergoing conservative or operative treatment of the knee. These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. In 12 Items the awareness for the artificial joint is assessed by the patient, each on a five point scale (Never / Almost Never / Seldom / Sometimes / Mostly)	At final follow-up at least 2 years after surgery
WOMAC Score	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain (5 items), stiffness (2 items), and physical functioning (17 items) of the joints. Each item is assessed by the patient on a five point scale (none / slight / moderate / severe / extreme)	At final follow-up at least 2 years after surgery
KSS Score	The KSS is an examiner--administrated standard clinical evaluation tool reporting results for patients undergoing TKA. It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.	At final follow-up at least 2 years after surgery
Implant survival	Survival in the sense of this study is defined as a removal or exchange of any revision implant components including the removal or exchange of the PE meniscus component. Secondary interventions at the index knee e.g. secondary patella replacement do not count as a revision if no further exchange of the former implant components occur. The revision-free survival rate is the performance indicator of the product under investigation and confirms the clinical outcome of the knee prosthesis. Information on survival of the implant will be collected until the last follow-up of the study patients took place.	Until final follow-up at least 2 years after surgery
Documentation of Adverse events/serious adverse events	During the course of the study, any upcoming intra- or postoperative (serious) adverse device events or effects related or not related to the product under investigation, will be documented in the dedicated Case Report Forms The total number of AEs will be summarized and further evaluated by the sponsor Recorded complications will be categorized and analyzed in order to assess the safety of the investigational product	over the whole course of the study from surgery until final follow-up at least 2 years after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive analysis of Radiological assessment	All follow-up imaging exams will be obtained according to the radiographic protocol of the hospital and the set routine. Imaging will be used to evaluate the implant status as well as device condition and potential presence of device-related Adverse Events including fracture, wear, loosening or radiolucencies, as well as the parameters of joint line restoration, rotational alignment and posterior condylar offset.	from discharge until final follow-up at least 2 years after surgery

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Emilio Larrazabal Raluy, MD, Hospital Universitario Cruces, Spain; Principal Investigator: Igor Gonzales, MD, Hospital Universitario Cruces, Spain

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): March 24, 2024

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Observational Study; Revision; Computer Assisted Surgery; Joint Alignment; Forgotten Joint Score
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Prosthesis Failure; Prosthesis-Related Infections
• Other Study ID Numbers: AAG-O-H-2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No