Knee OsteoarthritisCOREVNCT05113303
COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
An observational study of Knee Osteoarthritis and Bone; Deformity, Congenital, run by Aesculap AG at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Bone; Deformity, Congenital, Prosthesis Failure
- What is being tested?
- Navigated Revision Total Knee Arthroplasty and Manual Revision Total Knee Arthroplasty
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 16 Mar 2022to 24 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Patient Age at time of revision surgery < 18 years
- Allergy to any prosthesis component
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The study's main purpose is the collection of clinical data on the safety and performance of the Columbus® Revision Knee endoprosthesis
- Conditions
- Knee Osteoarthritis, Bone; Deformity, Congenital, Prosthesis Failure, Prosthesis-Related Infections
- Being tested
- Navigated Revision Total Knee Arthroplasty, Manual Revision Total Knee Arthroplasty
- Keywords
- Computer Assisted Surgery, Revision, Total Knee Arthroplasty, Joint Alignment, Observational Study, Forgotten Joint Score
- Medical subject headings
- Osteoarthritis, Knee, Congenital Abnormalities, Prosthesis Failure, Prosthesis-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigated Revision Total Knee ArthroplastyDevice
Patients in the case group receive a Columbus® Revision knee prosthesis, implanted with computer assisted surgery
Manual Revision Total Knee ArthroplastyDevice
Patients in the control group will correspond to a historical cohort of patients in which manual jig-assisted knee revision was done.
| Study group | Role | What they receive |
|---|---|---|
| navigation assisted knee revision surgery | Not described Receives: Device: Navigated Revision Total Knee Arthroplasty | |
| manual procedure | Not described Receives: Device: Manual Revision Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The HKA within 3 degrees of neutral has been used as the essential outcome measure in TKA.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: over the whole course of the study from surgery until final follow-up at least 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start16 Mar 2022
- Primary completion16 Jun 2023
- Study completion24 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Emilio Larrazabal Raluy, MD, Principal investigator, Hospital Universitario Cruces, SpainIgor Gonzales, MD, Principal investigator, Hospital Universitario Cruces, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113303
- Sponsor's protocol ID
- AAG-O-H-2012
- Acronym
- COREV
- Status last verified
- Aug 2025
- First submitted
- 11 Oct 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Case Control, Mono-center PMCF Study on Manual and Navigated Revision Knee Patients After a Minimum Follow-Up of Two Years
- ClinicalTrials.gov ID
- NCT05113303
- Acronym / sponsor ID
- COREV / AAG-O-H-2012
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| navigation assisted knee revision surgery | – | Device: Navigated Revision Total Knee Arthroplasty |
| manual procedure | – | Device: Manual Revision Total Knee Arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Patient Age at time of revision surgery < 18 years
- Allergy to any prosthesis component
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigated Revision Total Knee ArthroplastyPatients in the case group receive a Columbus® Revision knee prosthesis, implanted with computer assisted surgery | Device | navigation assisted knee revision surgery |
| Manual Revision Total Knee ArthroplastyPatients in the control group will correspond to a historical cohort of patients in which manual jig-assisted knee revision was done. | Device | manual procedure |
Primary outcome
Compare the final joint line height between groups after the surgical restoration of native joint line height of revision implants
Time frame: Comparison of final joint line height before the surgery with height at the 3 months follow-up
Joint line height will be assessed using the systematic, comparative x-ray analysis
6 secondary outcomes
Maintenance of Hip knee Ankle Angle
Time frame: Comparison of HKA before the surgery with HKA at 3 months and 2 years follow-up
Forgotten Joint Score
Time frame: At final follow-up at least 2 years after surgery
WOMAC Score
Time frame: At final follow-up at least 2 years after surgery
KSS Score
Time frame: At final follow-up at least 2 years after surgery
Implant survival
Time frame: Until final follow-up at least 2 years after surgery
Documentation of Adverse events/serious adverse events
Time frame: over the whole course of the study from surgery until final follow-up at least 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilio Larrazabal Raluy, MD principal investigator
Hospital Universitario Cruces, Spain
Igor Gonzales, MD principal investigator
Hospital Universitario Cruces, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Bone; Deformity, Congenital, run by Aesculap AG at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the final joint line height between groups after the surgical restoration of native joint line height of revision implants (time frame: Comparison of final joint line height before the surgery with height at the 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.