NCT05006274

Brief Summary

The purpose of this evaluation is to evaluate the intraoperative soft tissue balance as assessed by the Orthosensor device, to measure the perioperative gait and function with the Muvr tracking device, and to correlate this soft tissue balance with early functional outcomes in the Persona total knee system.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

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

First Submitted

Initial submission to the registry

July 21, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

August 13, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

July 21, 2021

Last Update Submit

August 14, 2021

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (17)

  • Active and passive range of motion

    Flexion and extension measurements of knee

    2 weeks

  • Active and passive range of motion

    Flexion and extension measurements of knee

    6 weeks

  • Active and passive range of motion

    Flexion and extension measurements of knee

    12 weeks

  • Active and passive range of motion

    Flexion and extension measurements of knee

    1 year

  • Implant alignment

    Radiographic assessments

    2 weeks post-operatively

  • Implant alignment

    Radiographic assessments

    6 weeks post-operatively

  • Implant alignment

    Radiographic assessments

    12 weeks post-operatively

  • Implant alignment

    Radiographic assessments

    1 year post-operatively

  • Knee Society Score (KSS)

    Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, higher score better.

    2 weeks post-operatively

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-96, lower score means less disability

    2 weeks post-operatively

  • Forgotten Joint Score (FJS)

    Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, 100 being better score

    2 weeks post-operatively

  • Knee Society Score (KSS)

    Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, higher score better.

    12 weeks post-operatively

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-96, lower score means less disability

    12 weeks post-operatively

  • Forgotten Joint Score (FJS)

    Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, 100 being better score

    12 weeks post-operatively

  • Knee Society Score (KSS)

    Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, higher score better.

    52 weeks post-operatively

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-96, lower score means less disability

    52 weeks post-operatively

  • Forgotten Joint Score (FJS)

    Patient-reported outcome surveys assessing pain and function after total knee arthroplasty. Range 0-100, 100 being better score

    52 weeks post-operatively

Study Arms (2)

Group 1-Traditional soft tissue balance

Patients in group 1 will receive traditional, manual soft-tissue balancing during surgery. For the purpose of the study, the balance will be quantitatively assessed at the end of the case, by means of surgeon-blinded VERASENSE measurements before and after cementation.

Device: Persona Trabecular Metal TibiaDevice: Verasense technologyDevice: MUVR

Group 2-Soft tissue balance using VERASENSE

For the patients in Group 2, intra-operative sensor feedback will be used in creating a quantitatively balanced knee (VERASENSE, OrthoSensor Inc.). Thereby, a quantitatively balanced knee is characterized by a mediolateral load differential below 15lbs at 10-45-90 degrees of flexion.

Device: Persona Trabecular Metal TibiaDevice: Verasense technologyDevice: MUVR

Interventions

Persona Trabecular Metal TibiaDEVICE

Total knee arthroplasty

Group 1-Traditional soft tissue balanceGroup 2-Soft tissue balance using VERASENSE
Verasense technologyDEVICE

Instrumented tibial trial component

Group 1-Traditional soft tissue balanceGroup 2-Soft tissue balance using VERASENSE
MUVRDEVICE

Knee motion and gait sensing wearable device

Group 1-Traditional soft tissue balanceGroup 2-Soft tissue balance using VERASENSE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy individuals having elective primary knee replacement

You may qualify if:

  • Patient has a primary indication of osteoarthritis and is eligible for primary total knee arthroplasty using the Persona total knee system
  • Patient is willing and able to provide written Informed Consent prior to study surgery
  • Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form

You may not qualify if:

  • Patient does not have a primary indication of osteoarthritis
  • Patient does not have access to internet or mobile device or understand how to use phone/app
  • Patient is not eligible or will not receive the Persona total knee system
  • Patient has not provided written Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Hospital

Fremont, California, 94538, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Alexander Sah, MD

CONTACT

510-818-7200info@SahOrtho.com

Alexander Alexander, MD

CONTACT

510-818-7200info@SahOrtho.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician and Research Chair, Institute for Joint Restoration and Research

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 16, 2021

Study Start

August 13, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)