IRCCS Istituto Ortopedico Rizzoli
Bologna, Emilia-Romagna, 40136, Italy
NCT Number: NCT05204797
The purpose of this study is to compare the percentage of early micromibilisation in unicompartmental knee arthroplasties in robot-assisted technique vs standard technique.
This study is active but is not currently recruiting participants.
Notify Me50 year–80 year
All sexes
Interventional
Not applicable
Bologna, Emilia-Romagna, 40136, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients.
Other names: CORI Surgical System, Smith and Nephew
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and standard technique. Tourniquet will be used in all patients.
Time frame: Within 7 days from surgery, during hospitalisation
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Time frame: 3 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Time frame: 6 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Time frame: 12 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Time frame: 24 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Time frame: Within 7 days from surgery, during hospitalisation
Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis.
Time frame: 6 months
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
Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis.
Time frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
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
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
A short personal questionnaire that assesses subjective satisfaction after surgery
Time frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
a questionnaire filled by the patient assessing the overall health of the subject. It is a test used to assess quality of life index.
Istituto Ortopedico Rizzoli
Other
Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After Unicompartmental Knee Arthroplasty: a Controlled Randomized Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06924567
Hip Arthropathy, Loosening, Prosthesis
Copenhagen, Denmark
View Trial DetailsNCT04773054
Infections, Loosening, Prosthesis
Bologna, Italy
View Trial DetailsNCT04255966
Arthritis, Arthroplasty Complications
Würzburg, Bavaria, Germany
View Trial DetailsNCT03520101
Aortic Valve Disease, Aortic Valve Insufficiency
Québec, Quebec, Canada
View Trial Details