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Clinical Trials/NCT05365022
NCT05365022
Unknown
N/A

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

Borja Alcobía-Díaz MD, PhD1 site in 1 country144 target enrollmentFebruary 10, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Prosthetic Surgery
Sponsor
Borja Alcobía-Díaz MD, PhD
Enrollment
144
Locations
1
Primary Endpoint
Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery
Last Updated
3 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 10, 2021
End Date
September 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Borja Alcobía-Díaz MD, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Borja Alcobía-Díaz MD, PhD

MD, PhD. Clinical Professor

Hospital San Carlos, Madrid

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery

Time Frame: 6 months after surgery

Correct lower limb mechanical alignment

Secondary Outcomes

  • Technique reproducibility between surgeons(Intraoperative)
  • Time to Recovery(1 year after surgery)
  • Patient satisfaction(1 year after surgery)
  • Pain Control(1 year after surgery)
  • Time to home discharge(1 month)
  • Implant Stability(1 year after surgery)
  • Mobility(1 year after surgery)
  • Complications(1 year after surgery)
  • Technique Timing at Operating Room (OR)(Intraoperative)

Study Sites (1)

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