Recruiting

Observational Study

Sponsor:

Washington Hospital Healthcare System

Code:

NCT05006274

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Persona Trabecular Metal Tibia

Verasense technology

MUVR

Study Details

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.

Conditions

Osteoarthritis, Knee

Study ID

NCT05006274

Start date

Aug 13, 2021

Status verified date

Aug, 2021

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Persona Trabecular Metal Tibia

Total knee arthroplasty

Verasense technology

Instrumented tibial trial component

MUVR

Knee motion and gait sensing wearable device

Primary outcome measure

  • Active and passive range of motion [ Time Frame: 2 weeks ]
  • Active and passive range of motion [ Time Frame: 6 weeks ]
  • Active and passive range of motion [ Time Frame: 12 weeks ]
  • Active and passive range of motion [ Time Frame: 1 year ]
  • Implant alignment [ Time Frame: 2 weeks post-operatively ]
  • Implant alignment [ Time Frame: 6 weeks post-operatively ]
  • Implant alignment [ Time Frame: 12 weeks post-operatively ]
  • Implant alignment [ Time Frame: 1 year post-operatively ]
  • Knee Society Score (KSS) [ Time Frame: 2 weeks post-operatively ]
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 2 weeks post-operatively ]
  • Forgotten Joint Score (FJS) [ Time Frame: 2 weeks post-operatively ]
  • Knee Society Score (KSS) [ Time Frame: 12 weeks post-operatively ]
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 12 weeks post-operatively ]
  • Forgotten Joint Score (FJS) [ Time Frame: 12 weeks post-operatively ]
  • Knee Society Score (KSS) [ Time Frame: 52 weeks post-operatively ]
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 52 weeks post-operatively ]
  • Forgotten Joint Score (FJS) [ Time Frame: 52 weeks post-operatively ]

Central Contacts and Locations

Central contacts

Alexander Sah, MD

510-818-7200info@SahOrtho.com

Alexander Alexander, MD

510-818-7200info@SahOrtho.com

Locations

Washington Hospital

Recruiting

Fremont, California, United States, 94538

Contacts

Alexander Sah, MD

510-818-7200

More Information

Sponsor

Washington Hospital Healthcare System

Last update posted

Aug 19, 2021

Last verified

Aug, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington Hospital Healthcare System on 2021-08-19.