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

Sponsor
Borja Alcobía-Díaz MD, PhD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05365022
Collaborator
(none)
144
1
2
18.7
7.7

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
  • Device: ROSA® System Robotic Assisted Knee Prosthetic Surgery
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System.
Actual Study Start Date :
Feb 10, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Conventional Non-Robotic Assisted Knee Prosthetic Surgery

Active Comparator: ROSA® System Robotic Assisted Knee Prosthetic Surgery

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

Outcome Measures

Primary Outcome Measures

  1. Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery [6 months after surgery]

    Correct lower limb mechanical alignment

Secondary Outcome Measures

  1. Mobility [1 year after surgery]

    Range of Motion in degrees

  2. Technique reproducibility between surgeons [Intraoperative]

    Reproducing mechanical alignment in degrees

  3. Patient satisfaction [1 year after surgery]

    Patient satisfaction in a numeric scale from 1 to 10

  4. Time to Recovery [1 year after surgery]

    Time to feel patients themselves better than presurgery in months

  5. Time to home discharge [1 month]

    Hospital stay in days between surgery and discharging home

  6. Pain Control [1 year after surgery]

    Pain measurement with Visual Analogue Scale (VAS)

  7. Technique Timing at Operating Room (OR) [Intraoperative]

    Timing in minutes to measure reproducibility between surgeons

  8. Implant Stability [1 year after surgery]

    Presence of varus / valgus instability

  9. Complications [1 year after surgery]

    Major /Minor Complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

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.
Responsible Party:
Borja Alcobía-Díaz MD, PhD, MD, PhD. Clinical Professor, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT05365022
Other Study ID Numbers:
  • 22/081-EC_P
First Posted:
May 6, 2022
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Borja Alcobía-Díaz MD, PhD, MD, PhD. Clinical Professor, Hospital San Carlos, Madrid

Study Results

No Results Posted as of May 6, 2022