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

Not Applicable

Active, not recruiting

• Conditions: Loosening, Prosthesis
• Interventions: Procedure: Standard technique UKA; Procedure: Robot-assisted UKA

• Registration Number: NCT05204797
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-27
• Study Start: 2021-10-07
• Study First Submitted QC: 2022-01-08
• Study First Posted: 2022-01-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2026-10-14
• Study Completion: 2026-10-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard technique UKA	Standard technique UKA	Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via standard technique.
Robot-assisted UKA	Robot-assisted UKA	Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via CORI surgical system (Smith \& Nephew, USA).

Primary Outcome Measures

Name	Time	Method
Static radiostereometric analysis (RSA)	24 months	Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

Secondary Outcome Measures

Name	Time	Method
Gait analysis via inertial sensors	24 months	Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis.
Oxford Knee Score	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.
American Knee Society score	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
Patient Satisfaction Score	Pre-operatively, then at 3, 6, 12 and 24 months follow-up	A short personal questionnaire that assesses subjective satisfaction after surgery
EQ5-D questionnaire	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.

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Emilia Romagna, Italy