Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System

Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System.

Comparing clinical and radiological results of patients after prosthetic surgery conventionally with no robotic assistance and ROSA® Knee prosthetic surgery robotic assistance.

Study Overview

• Status: Recruiting
• Conditions: Knee Prosthetic Surgery; Robotic Assistance
• Intervention / Treatment: Device: ROSA® System Robotic Assisted Knee Prosthetic Surgery

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Knee osteoarthritis requiring PS Knee Prosthesis

Exclusion Criteria:

• Not meeting Inclusion Criteria
• Requiring Constrained Prosthesis
• Metal Allergy
• Neurological disorders.
• Cognitive impairment
• Not giving consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional Non-Robotic Assisted Knee Prosthetic Surgery
Active Comparator: ROSA® System Robotic Assisted Knee Prosthetic Surgery	Device: ROSA® System Robotic Assisted Knee Prosthetic Surgery; Robotic Assisted Knee Prosthetic Surgery using ROSA® (Zimmer-Biomet) System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery	Correct lower limb mechanical alignment	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility	Range of Motion in degrees	1 year after surgery
Technique reproducibility between surgeons	Reproducing mechanical alignment in degrees	Intraoperative
Patient satisfaction	Patient satisfaction in a numeric scale from 1 to 10	1 year after surgery
Time to Recovery	Time to feel patients themselves better than presurgery in months	1 year after surgery
Time to home discharge	Hospital stay in days between surgery and discharging home	1 month
Pain Control	Pain measurement with Visual Analogue Scale (VAS)	1 year after surgery
Technique Timing at Operating Room (OR)	Timing in minutes to measure reproducibility between surgeons	Intraoperative
Implant Stability	Presence of varus / valgus instability	1 year after surgery
Complications	Major /Minor Complications	1 year after surgery

Collaborators and Investigators

• Sponsor: Borja Alcobía-Díaz MD, PhD
• Investigators: Study Chair: Borja Alcobia-Díaz, MD, PhD, Clinical Assistant

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Knee prosthetic surgery robotic assistance
• Other Study ID Numbers: 22/081-EC_P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Email contact

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes