Clinical trial NCT05113303: COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
Official title: Comparative, Case Control, Mono-center PMCF Study on Manual and Navigated Revision Knee Patients After a Minimum Follow-Up of Two Years
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2021-11-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Compare the final joint line height between groups after the surgical restoration of native joint line height of revision implants
timeFrame: Comparison of final joint line height before the surgery with height at the 3 months follow-up
Secondary outcomes:
measure: Maintenance of Hip knee Ankle Angle
timeFrame: Comparison of HKA before the surgery with HKA at 3 months and 2 years follow-up
measure: Forgotten Joint Score
timeFrame: At final follow-up at least 2 years after surgery
measure: WOMAC Score
timeFrame: At final follow-up at least 2 years after surgery
measure: KSS Score
timeFrame: At final follow-up at least 2 years after surgery
measure: Implant survival
timeFrame: Until final follow-up at least 2 years after surgery
measure: Documentation of Adverse events/serious adverse events
timeFrame: over the whole course of the study from surgery until final follow-up at least 2 years after surgery
Other outcomes:
measure: Descriptive analysis of Radiological assessment
timeFrame: from discharge until final follow-up at least 2 years after surgery
Locations:
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
state: Bizkaia
Study officials:
affiliation: Hospital Universitario Cruces, Spain
name: Emilio Larrazabal Raluy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Cruces, Spain
name: Igor Gonzales, MD
role: PRINCIPAL_INVESTIGATOR
References: