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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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The purpose of this study is to compare the percentage of early micromibilisation in unicompartmental knee arthroplasties in robot-assisted technique vs standard technique.
The purpose of the study is to compare the percentage of early micromobilisation by static radiostereometric analysis (RSA) - primary outcome, gait analysis by inertial sensors to assess gait kinematics, and clinical perdormance measured by american knee society score (AKSS), oxford knee score (OKS), patient satisfaction score (PSS) and EQ5-D - secondary outcomes, among 2 groups of patients, of 25 individuals each, whi undergo medial unicompartmental knee arthroplasty.
The first group will be operated with a robot-assisted technique (with CORI Surgical System, Smith and Nephew, USA), the other with standard technique and the same implant (Journey UNI II, Smith and Nephew, USA).
The study will be a randomized and controlled blind superiority trial. Patients will not be informed about performing the surgery with one technique or the other in order to avoid potential biases in the data analysis.
Patients will be recruited at the orthoaedic and traumatologic 2nd clinica (head prof S. Zaffagnini) at IRCSS Istituto Ortopedico Rizzoli in Bologna, Italy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted UKA | Experimental | Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via CORI surgical system (Smith & Nephew, USA). |
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| Standard technique UKA | Active Comparator | Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via standard technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted UKA | Procedure | Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Static radiostereometric analysis (RSA) | Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison | Within 7 days from surgery, during hospitalisation |
| Static radiostereometric analysis (RSA) | Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison | 3 months |
| Static radiostereometric analysis (RSA) | Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison | 6 months |
| Static radiostereometric analysis (RSA) | Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison | 12 months |
| Static radiostereometric analysis (RSA) | Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gait analysis via inertial sensors | Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis. | Within 7 days from surgery, during hospitalisation |
| Gait analysis via inertial sensors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Zaffagnini, Prof. | IRCCS Istituto Ortopedico Rizzoli | Principal Investigator |
| Giulio Maria Marcheggiani Muccioli, Prof. | IRCCS Istituto Ortopedico Rizzoli | Study Director |
| Stefano Fratini, Dr. | IRCCS Istituto Ortopedico Rizzoli | Study Chair |
| Stefano Di Paolo, Eng. | University of Bologna | Study Chair |
| Laura Bragonzoni, Dr. | University of Bologna | Study Chair |
| Raffaele Zinno, Dr. | University of Bologna | Study Chair |
| Giuseppe Barone, Dr. | University of Bologna | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Ortopedico Rizzoli | Bologna | Emilia-Romagna | 40136 | Italy |
No sharing planned
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| ID | Term |
|---|---|
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Two blinded groups operated via robotic-assisted surgery (1st arm) or conventional technique (2nd arm).
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At the research office of health professions at IRCCS Istituto Ortopedico Rizzoli in Bologna, Italy (coordinating centre), a block of 5 randomisation list using the site "www.randomisation.com" will be generated. A sequence of opaque envelopes will be set up with a sequential number on the outside. A label will be placed iside the envelope that will contain the words "CORI" or "STANDARD", according to the sequence indicated by the generated list. Envelopes will be always sealed at the Research Centre and the list kept under lock. The envelopes will be placed in a dedicated box and delivered to the studio manager.
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| Standard technique UKA | Procedure | Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and standard technique. Tourniquet will be used in all patients. |
|
Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis. |
| 6 months |
| Gait analysis via inertial sensors | Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis. | 24 months |
| American Knee Society score | Used to test knee function by the investigator: it has a clinical and a functional part | Pre-operatively, then at 3, 6, 12 and 24 months follow-up |
| Oxford Knee Score | Consists of 12 questions to be filled by the patient to assess how the prosthesis affect activities of daily living. | Pre-operatively, then at 3, 6, 12 and 24 months follow-up |
| Patient Satisfaction Score | A short personal questionnaire that assesses subjective satisfaction after surgery | Pre-operatively, then at 3, 6, 12 and 24 months follow-up |
| EQ5-D questionnaire | a questionnaire filled by the patient assessing the overall health of the subject. It is a test used to assess quality of life index. | Pre-operatively, then at 3, 6, 12 and 24 months follow-up |