Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After UKA

Loosening, Prosthesis Clinical Trial

Official title:

Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After Unicompartmental Knee Arthroplasty: a Controlled Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05204797
• Other study ID #: RSA UNI CORI
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Stefano Zaffagnini, Prof.
• Phone: 00390516366111
• Email: stefano.zaffagnini[@]unibo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the percentage of early micromibilisation in unicompartmental knee arthroplasties in robot-assisted technique vs standard technique.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Unicompartmental Knee Arthrosis
• Femoral condyles or medial tibial plate osteonecrosis
• Healthy anterior cruciate ligament, posterior cruciate ligament and collateral ligaments of the affected knee
• Post traumatic loss of joint configuration
• Moderate varism deformity
• Patients between 50 and 80 years old
• Patients able to undergo a 2-year follow up after surgery

Exclusion Criteria:

• Bi or Tricompartmental arthrosis
• Unhealty anterior or posterior cruciate ligaments or collateral ligaments
• Patients with neuromuscolar, degenerative and joint-related conditions
• Patients younger than 50
• Patients older than 80
• Patients unable to undergo a 2-year follow up after surgery

Related Conditions & MeSH terms

• Loosening, Prosthesis
• Prosthesis Failure

Intervention

Procedure:
• Robot-assisted UKA
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients.
• Standard technique UKA
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and standard technique. Tourniquet will be used in all patients.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna	Emilia Romagna

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli	Smith & Nephew, Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static radiostereometric analysis (RSA)	Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison	Within 7 days from surgery, during hospitalisation
Primary	Static radiostereometric analysis (RSA)	Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison	3 months
Primary	Static radiostereometric analysis (RSA)	Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison	6 months
Primary	Static radiostereometric analysis (RSA)	Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison	12 months
Primary	Static radiostereometric analysis (RSA)	Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison	24 months
Secondary	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
Secondary	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.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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