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

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

Detailed Description
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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.

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

Conditions
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Loosening, Prosthesis

Intervention / Treatment
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* Procedure: Robot-assisted UKA
* Procedure: Standard technique UKA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two blinded groups operated via robotic-assisted surgery (1st arm) or conventional technique (2nd arm).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted UKA<br>Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via CORI surgical system (Smith & Nephew, USA). | Procedure: Robot-assisted UKA<br>* Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients.<br>* Other names: CORI Surgical System, Smith and Nephew;|
| Active Comparator: Standard technique UKA<br>Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via standard technique. | Procedure: Standard technique UKA<br>* Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and standard technique. Tourniquet will be used in all patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static radiostereometric analysis (RSA) | Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison | Within 7 days from surgery, during hospitalisation | 
| Static radiostereometric analysis (RSA) | Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison | 3 months | 
| Static radiostereometric analysis (RSA) | Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison | 6 months | 
| Static radiostereometric analysis (RSA) | Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison | 12 months | 
| Static radiostereometric analysis (RSA) | Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |