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Comparing clinical and radiological results of patients after prosthetic surgery conventionally with no robotic assistance and ROSA® Knee prosthetic surgery robotic assistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Non-Robotic Assisted Knee Prosthetic Surgery | No Intervention | ||
| ROSA® System Robotic Assisted Knee Prosthetic Surgery | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROSA® System Robotic Assisted Knee Prosthetic Surgery | Device | Robotic Assisted Knee Prosthetic Surgery using ROSA® (Zimmer-Biomet) System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery | Correct lower limb mechanical alignment | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility | Range of Motion in degrees | 1 year after surgery |
| Technique reproducibility between surgeons | Reproducing mechanical alignment in degrees |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Borja Alcobia-Díaz, MD, PhD | Contact | 913303001 | 3638 | dralcobiacot@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Borja Alcobia-Díaz, MD, PhD | Clinical Assistant | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico San Carlos | Recruiting | Madrid | 28040 | Spain |
Email contact
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| Intraoperative |
| Patient satisfaction | Patient satisfaction in a numeric scale from 1 to 10 | 1 year after surgery |
| Time to Recovery | Time to feel patients themselves better than presurgery in months | 1 year after surgery |
| Time to home discharge | Hospital stay in days between surgery and discharging home | 1 month |
| Pain Control | Pain measurement with Visual Analogue Scale (VAS) | 1 year after surgery |
| Technique Timing at Operating Room (OR) | Timing in minutes to measure reproducibility between surgeons | Intraoperative |
| Implant Stability | Presence of varus / valgus instability | 1 year after surgery |
| Complications | Major /Minor Complications | 1 year after surgery |