An observational study in Knee Osteoarthritis, Bone; Deformity, Congenital and Prosthesis Failure, sponsored by Aesculap AG. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Aesculap AG (part of B. Braun) · Observational
Among 100 studies in Osteoarthritis, Knee with a site in Spain — 16 open to participants now, 19 under way, 3 of them phase 3. Osteoarthritis, Knee · Spain.
Among the 100 studies in Osteoarthritis, Knee with a site in Spain, this one is the 12th largest by enrollment of the 14 observational ones, is one of 9 that started in 2022, is one of 14 observational ones, and was the 67th registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →16 of the 100 studies in Osteoarthritis, Knee with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →100 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 9 started in 2022.
Median enrollment 100 across the 86 interventional studies, 153 across the 14 observational. Of the 71 that completed or were terminated, 19 (27%) have results posted.
43 of 100 have an industry lead sponsor. The 10 most frequent:
Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Aesculap AG has 7 studies filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
4 of the studies in Osteoarthritis, Knee with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06721897University of JaénEffectiveness of a Prehabilitation Program for Hip or Knee Arthroplasty Surgery. | 2026-11-30 |
| NCT07434011Universidad Complutense de MadridEfficacy of Artificial Intelligence-Assisted Therapeutic Exercise in Patients With Knee Osteoarthritis | 2027-03-15 |
| NCT07886697Universidad Rey Juan CarlosLow-Dose Radiotherapy for Painful Knee Osteoarthritis | 2027-06-30 |
| NCT07870967Universidad Católica San Antonio de MurciaUndenatured Type II Collagen for Knee Osteoarthritis Pain | 2027-07 |
Among the 100 studies in Osteoarthritis, Knee with a site in Spain, from their registry updates:
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.
The study's main purpose is the collection of clinical data on the safety and performance of the Columbus® Revision Knee endoprosthesis
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Navigated Revision Total Knee Arthroplasty
Device: Manual Revision Total Knee Arthroplasty
Patients in the case group receive a Columbus® Revision knee prosthesis, implanted with computer assisted surgery
Patients in the control group will correspond to a historical cohort of patients in which manual jig-assisted knee revision was done.
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
Time frame: Comparison of final joint line height before the surgery with height at the 3 months follow-up
Maintenance of Hip knee Ankle Angle
The HKA within 3 degrees of neutral has been used as the essential outcome measure in TKA.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: over the whole course of the study from surgery until final follow-up at least 2 years after surgery
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.
Time frame: from discharge until final follow-up at least 2 years after surgery
Ran from Mar 2022 to primary completion in Jun 2023, 15 months.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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