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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
50
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients.
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and standard technique. Tourniquet will be used in all patients.
IRCCS Istituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, Italy
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Time frame: Within 7 days from surgery, during hospitalisation
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Time frame: 3 months
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Time frame: 6 months
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Time frame: 12 months
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Time frame: 24 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.
Time frame: Within 7 days from surgery, during hospitalisation
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.
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Time frame: 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.
Time frame: 24 months
American Knee Society score
Used to test knee function by the investigator: it has a clinical and a functional part
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up