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.
Investigators
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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