NCT05365022

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 25, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

February 25, 2022

Last Update Submit

May 3, 2022

Conditions

Knee Prosthetic SurgeryRobotic Assistance

Keywords

Knee prosthetic surgery robotic assistance

Outcome Measures

Primary Outcomes (1)

  • Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery

    Correct lower limb mechanical alignment

    6 months after surgery

Secondary Outcomes (9)

  • Mobility

    1 year after surgery

  • Technique reproducibility between surgeons

    Intraoperative

  • Patient satisfaction

    1 year after surgery

  • Time to Recovery

    1 year after surgery

  • Time to home discharge

    1 month

  • +4 more secondary outcomes

Study Arms (2)

Conventional Non-Robotic Assisted Knee Prosthetic Surgery

NO INTERVENTION

ROSA® System Robotic Assisted Knee Prosthetic Surgery

ACTIVE COMPARATOR
Device: ROSA® System Robotic Assisted Knee Prosthetic Surgery

Interventions

ROSA® System Robotic Assisted Knee Prosthetic SurgeryDEVICE

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

ROSA® System Robotic Assisted Knee Prosthetic Surgery

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee osteoarthritis requiring PS Knee Prosthesis

You may not qualify if:

  • Requiring Constrained Prosthesis
  • Metal Allergy
  • Neurological disorders.
  • Cognitive impairment
  • Not giving consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Study Officials

  • Borja Alcobia-Díaz, MD, PhD

    Clinical Assistant

    STUDY CHAIR

Central Study Contacts

Borja Alcobia-Díaz, MD, PhD

CONTACT

913303001dralcobiacot@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD. Clinical Professor

Study Record Dates

First Submitted

February 25, 2022

First Posted

May 6, 2022

Study Start

February 10, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

May 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Email contact

Locations

ES(1)