NCT03970629

Terminated

ROSA Total Knee Investigational Testing Authorization Study

Zimmer Biomet Source

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Other study identifiers

Sponsor study identifier

CEU2018-46K

Study Type

interventional

Actual enrollment (reported)

19

Locations

1 country

Sites

1

Timeline

Study Start

June 20, 2019

Actual (reported)

Primary Completion

November 23, 2021

Actual (reported)

Study Completion

November 23, 2021

Actual (reported)

Brief Summary

This is a prospective, single-center clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona Total Knee components using the ROSA Total Knee Robotic System or conventional instrumentation.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 19 participants
Study completion date: November 23, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 30, 2019
Actual (reported)
First Posted
May 31, 2019
Actual (reported)
Study Start
June 20, 2019
Actual (reported)
Primary Completion
November 23, 2021
Actual (reported)
Study Completion
November 23, 2021
Actual (reported)

Last Updated: May 19, 2022
Status Verified: May 2022
Last Update Submitted: May 12, 2022

Conditions

Avascular Necrosis of Femoral Condyle Chronic Osteoarthritis Knee Pain Moderate Varus, Valgus or Flexion Deformities Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

EQ-5D questionnaire
EQ-5D
1 year
Oxford Knee Score Questionnaire
Oxford Knee Score
1 year

Study Arms (2)

Robotic Assisted TKA

ACTIVE COMPARATOR

Robotic Assisted TKA via ROSA Robot

Device: PERSONA Total Knee

Conventional TKA

ACTIVE COMPARATOR

Conventional TKA

Device: PERSONA Total Knee

Interventions

PERSONA Total KneeDevice

Primary Total Knee Arthroplasty

Conventional TKARobotic Assisted TKA

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient is a minimum of 18 years of age
Pre-op component positioning and sizing plan prior to surgery

Sponsors & Collaborators

Zimmer Biomet
Industrylead

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

MeSH Terms

Conditions

Genu ValgumArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Charles Jaggard
Zimmer Biomet
STUDY DIRECTOR

Enrollment

19 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 30, 2019

First Posted

May 31, 2019

Study Start

June 20, 2019

Actual (reported)

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Persona TM Tibia Clinical Outcomes Study

Not ApplicableCompleted

NCT04084236

The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain

Not ApplicableUnknown

NCT04817969

Persona Ti-Nidium Post-Market Clinical Follow-up

Not ApplicableActive Not Recruiting

NCT02399046

A Clinical Trial Study of Knee System in Primary Total Knee Arthroplasty in China

Not ApplicableCompleted

NCT03626038

Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System

Not ApplicableActive Not Recruiting

NCT03514355

MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms

Not ApplicableCompleted

Independent of study participation, patient is a candidate for primary TKA using the commercially available Persona knee components implanted in accordance with product labeling

Patient has participated in this study-related Informed Consent process

Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form

Patient is willing and able to complete scheduled study procedures and follow-up evaluations

You may not qualify if:

Patient is currently participating in any other surgical intervention studies or pain management studies
Patient has underwent contralateral UKA or TKA within the last 18 months
Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)
Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation)
Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Contact the study team to confirm eligibility.

Primary Completion

November 23, 2021

Actual (reported)

Study Completion

November 23, 2021

Actual (reported)

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03970629
Data provider: ClinicalTrials.gov
Source updated: 2022-05-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:30 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Robotic Assisted TKA

Conventional TKA

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations