Knee Arthroplasty, Total
Conditions
Brief summary
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.
Interventions
PROCEDUREconventional total knee arthroplasty
total knee arthroplasty performed with conventional technique
PROCEDUREcomputer-assisted total knee arthroplasty
total knee arthroplasty performed with imageless computer-assisted surgery
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with primary or secondary gonarthrosis with indication for knee arthroplasty with primary implant * Males and females aged ≥ 45 * Willingness to participate in the study * Acquisition of informed consent to participate
Exclusion criteria
* Patients who are not capable of understanding and willing, and therefore unable to express consent to participation in the study * Patient refusal to participate in the study and to sign the informed consent * Nickel allergy (suspected or diagnosed) * Pregnant women or women of childbearing age who cannot exclude pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score (KSS) | From enrollment to 12 months post-operative followup | 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 |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | from enrollment to 12 months post-operative followup | 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. |
| NRS scale | from enrollment to 12 months post-operative followup | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transfusions | from surgery to discharge, up to 4 weeks | It will be accounted the number of blood transfusions that patients may need during the hospital stay until discharge |
| surgical time | the day of surgical procedure | — |
| hospital stay | from surgery to discharge, up to 4 weeks | days of hospital stay from surgery to discharge |
| complications | from surgery to 12 month follow-up | using Clavien Dindo classification of surgical complications |
| delta hemoglobin | from surgery to discharge, up to 4 weeks | 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 |
Countries
Italy
Contacts
Primary ContactDallari (M.D.)
Backup ContactHaddad (M.D.)
Outcome results
None listed