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

NCT05113303 | Completed

• 1 other identifier: AAG-O-H-2012
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Computer Assisted Surgery; Revision; Total Knee Arthroplasty; Joint Alignment; Observational Study; Forgotten Joint Score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Maintenance of Hip knee Ankle Angle

  Comparison of HKA before the surgery with HKA at 3 months and 2 years follow-up

• Forgotten Joint Score

  At final follow-up at least 2 years after surgery

• WOMAC Score

  At final follow-up at least 2 years after surgery

• KSS Score

  At final follow-up at least 2 years after surgery

• Implant survival

  Until final follow-up at least 2 years after surgery

Other Outcomes (1)

• Descriptive analysis of Radiological assessment

  from discharge until final follow-up at least 2 years after surgery

Study Arms (2)

navigation assisted knee revision surgery

Device: Navigated Revision Total Knee Arthroplasty

manual procedure

Device: Manual Revision Total Knee Arthroplasty

Interventions

Navigated Revision Total Knee Arthroplasty DEVICE

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

navigation assisted knee revision surgery

Manual Revision Total Knee Arthroplasty DEVICE

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

manual procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aesculap AG: lead
• B.Braun Surgical SA: collaborator

Study Sites (1)

Hospital Universitario Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Congenital Abnormalities; Prosthesis Failure; Prosthesis-Related Infections

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Emilio Larrazabal Raluy, MD

  Hospital Universitario Cruces, Spain

  PRINCIPAL INVESTIGATOR

• Igor Gonzales, MD

  Hospital Universitario Cruces, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 9, 2021
• Study Start: March 16, 2022
• Primary Completion: June 16, 2023
• Study Completion: March 24, 2024
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

ES (1)