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

Not Applicable

• Conditions: Robotic Assistance; Knee Prosthetic Surgery
• Interventions: Device: ROSA® System Robotic Assisted Knee Prosthetic Surgery

• Registration Number: NCT05365022
• Lead Sponsor: Borja Alcobía-Díaz MD, PhD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-10
• Study First Submitted: 2022-02-25
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-03
• Last Update Submitted: 2022-05-03
• Study First Posted: 2022-05-06
• Last Update Posted: 2022-05-06
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ROSA® System Robotic Assisted Knee Prosthetic Surgery	ROSA® System Robotic Assisted Knee Prosthetic Surgery	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain