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The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom made Total Knee Arthroplasty | Experimental | Implant used is a patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland) |
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| Functionally aligned robotically assisted total knee arthroplasty | Active Comparator | Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom made Total Knee Arthroplasty | Device | Total knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome using the Forgotten Joint Score | Scale 0-100, higher score means better outcome | 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes using the Kujala anterior knee pain Score | Scale 0-100, higher score means better outcome | preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Patient satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Klasan, MD, PhD, EMBA | Contact | +436765085920 | klasan.antonio@me.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AUVA UKH Steiermark Standort Graz | Recruiting | Graz | Styria | 8020 | Austria |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2023 | Feb 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Randomized
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| Functionally aligned robotically assisted total knee arthroplasty | Device | Total knee replacement, Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker), using functional alignment strategy |
|
Question "Are you satisfied with the outcome of your operation" using a Likert scale with 5 points: 1- very dissatisfied, 2-dissatisfied, 3 - neither satisfied nor dissatisfied, 4 - satisfied, 5 - very satisfied
| preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Visual analog pain (VAS) scale | Scale 0-10, higher score means better outcome | preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Surgical and total theatre time | Perioperative phase |
| Opioid use | Total dosage of opioids, registered in Austria for pain management after knee replacement, administered to the patient during in-hospital stay: Hydromorphon, Tramadol, Oxycodone/Naloxon as well as number of ampules of Piritramid | Intraoperative stay |
| Number of physiotherapy sessions | Intraoperative stay |
| Range of motion measurements (in degrees) | Measurement using a manual goniometer. | preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Radiographic data including radiolucent lines | Incidence of radiolucent lines >1 mm, with zones defined according to the New Knee Society Classification | preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Revision rate | Minimum 2 years |
| AUVA UKH Steiermark Standort Kalwang | Recruiting | Kalwang | Styria | 8775 | Austria |
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| D012216 |
| Rheumatic Diseases |