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The study involves the enrollment of a sample of patients with indication for total knee replacement surgery in order to compare the conventional surgical technique currently used in the reference departments with the surgical technique with the aid of computer-assisted navigation.
The comparison between the two techniques will be performed in terms of clinical-functional results, perioperative bleeding and healthcare costs (surgical time, hospital stay).
The research protocol involves the participation of 160 total patients divided into two groups, of 80 patients each, by type of surgical technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional total knee arthroplasty surgery | Active Comparator |
| |
| computer-assisted total knee arthroplasty surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional total knee arthroplasty | Procedure | total knee arthroplasty performed with conventional technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score (KSS) | Knee Society Clinical Rating System (KSS): there are 2 section, "Knee Score" section and a "Functional Score" section; both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions | From enrollment to 12 months post-operative followup |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The score measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations. | from enrollment to 12 months post-operative followup |
| NRS scale | Numeric Pain Rating scale is a unidimensional measure of pain in which a patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. 0 = no pain, 10 = worst pain possible | from enrollment to 12 months post-operative followup |
| Measure | Description | Time Frame |
|---|---|---|
| surgical time | the day of surgical procedure | |
| complications | using Clavien Dindo classification of surgical complications | from surgery to 12 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dallari (M.D.) | Contact | 39+0516366252 | dante.dallari@ior.it | |
| Haddad (M.D.) | Contact | 39+0516366252 | dario.haddad@ior.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | Italy |
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| computer-assisted total knee arthroplasty | Procedure | total knee arthroplasty performed with imageless computer-assisted surgery |
|
| delta hemoglobin | For each patient blood loss will be assessed by measuring the difference in hemoglobin (g/dL) on the preoperative blood sample VS last blood sample before discharge | from surgery to discharge, up to 4 weeks |
| Transfusions | It will be accounted the number of blood transfusions that patients may need during the hospital stay until discharge | from surgery to discharge, up to 4 weeks |
| hospital stay | days of hospital stay from surgery to discharge | from surgery to discharge, up to 4 weeks |