Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System
Study Details
Study Description
Brief Summary
Comparing clinical and radiological results of patients after prosthetic surgery conventionally with no robotic assistance and ROSA® Knee prosthetic surgery robotic assistance.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: Conventional Non-Robotic Assisted Knee Prosthetic Surgery
|
|
Active Comparator: ROSA® System Robotic Assisted Knee Prosthetic Surgery
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Device: ROSA® System Robotic Assisted Knee Prosthetic Surgery
Robotic Assisted Knee Prosthetic Surgery using ROSA® (Zimmer-Biomet) System
|
Outcome Measures
Primary Outcome Measures
- Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery [6 months after surgery]
Correct lower limb mechanical alignment
Secondary Outcome Measures
- Mobility [1 year after surgery]
Range of Motion in degrees
- Technique reproducibility between surgeons [Intraoperative]
Reproducing mechanical alignment in degrees
- Patient satisfaction [1 year after surgery]
Patient satisfaction in a numeric scale from 1 to 10
- Time to Recovery [1 year after surgery]
Time to feel patients themselves better than presurgery in months
- Time to home discharge [1 month]
Hospital stay in days between surgery and discharging home
- Pain Control [1 year after surgery]
Pain measurement with Visual Analogue Scale (VAS)
- Technique Timing at Operating Room (OR) [Intraoperative]
Timing in minutes to measure reproducibility between surgeons
- Implant Stability [1 year after surgery]
Presence of varus / valgus instability
- Complications [1 year after surgery]
Major /Minor Complications
Eligibility Criteria
Criteria
Inclusion Criteria:
- Knee osteoarthritis requiring PS Knee Prosthesis
Exclusion Criteria:
-
Not meeting Inclusion Criteria
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Requiring Constrained Prosthesis
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Metal Allergy
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Neurological disorders.
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Cognitive impairment
-
Not giving consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hospital Clinico San Carlos | Madrid | Spain | 28040 |
Sponsors and Collaborators
- Borja Alcobía-Díaz MD, PhD
Investigators
- Study Chair: Borja Alcobia-Díaz, MD, PhD, Clinical Assistant
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22/081-EC_P