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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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05365022
Enrollment
144
Registered
2022-05-06
Start date
2021-02-10
Completion date
2022-09-30
Last updated
2022-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Prosthetic Surgery, Robotic Assistance

Keywords

Knee prosthetic surgery robotic assistance

Brief summary

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

Interventions

DEVICEROSA® System Robotic Assisted Knee Prosthetic Surgery

Robotic Assisted Knee Prosthetic Surgery using ROSA® (Zimmer-Biomet) System

Sponsors

Borja Alcobía-Díaz MD, PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery6 months after surgeryCorrect lower limb mechanical alignment

Secondary

MeasureTime frameDescription
Implant Stability1 year after surgeryPresence of varus / valgus instability
Mobility1 year after surgeryRange of Motion in degrees
Technique reproducibility between surgeonsIntraoperativeReproducing mechanical alignment in degrees
Patient satisfaction1 year after surgeryPatient satisfaction in a numeric scale from 1 to 10
Complications1 year after surgeryMajor /Minor Complications
Time to home discharge1 monthHospital stay in days between surgery and discharging home
Pain Control1 year after surgeryPain measurement with Visual Analogue Scale (VAS)
Technique Timing at Operating Room (OR)IntraoperativeTiming in minutes to measure reproducibility between surgeons
Time to Recovery1 year after surgeryTime to feel patients themselves better than presurgery in months

Countries

Spain

Contacts

Primary ContactBorja Alcobia-Díaz, MD, PhD
dralcobiacot@gmail.com913303001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026