Intraoperative Soft Tissue Balance in TKA

Evaluation of Intraoperative Soft-tissue Balance and Postoperative Functional Recovery After Total Knee Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Persona Trabecular Metal Tibia; Device: Verasense technology; Device: MUVR

Detailed Description

This is a single surgeon, prospective, controlled study consisting of 50 patients with a primary indication of OA who are eligible for primary total knee arthroplasty using the Persona total knee system.

The patients are equally divided in two groups; 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. 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.

Post-operatively, the patients will be evaluated using the Muvr device at the day of surgery, day of discharge and 2, 6, and 12 weeks, and 1 year postoperatively. This device will provide quantitative feedback on different gait metrics as well as function during activities of daily living such as stair climbing / stair descent, walking, and timed get up and go testing.

During each post-operative visit, the following metrics will be recorded:

• Active and passive range of motion
• Implant alignment
• Patient reported outcomes by means of Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Forgotten Joint Score (FJS)

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Alexander Sah, MD; Phone Number: 510-818-7200; Email: info@SahOrtho.com
• Study Contact Backup: Name: Alexander Alexander, MD; Phone Number: 510-818-7200; Email: info@SahOrtho.com

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Recruiting
      • Washington Hospital
      • Contact: Alexander Sah, MD; Phone Number: 510-818-7200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy individuals having elective primary knee replacement

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Tibia; Total knee arthroplasty; Device: Verasense technology; Instrumented tibial trial component; Device: MUVR; Knee motion and gait sensing wearable device
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 Tibia; Total knee arthroplasty; Device: Verasense technology; Instrumented tibial trial component; Device: MUVR; Knee motion and gait sensing wearable device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington Hospital Healthcare System
• Collaborators: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: August 7, 2021
• First Posted (ACTUAL): August 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 14, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: IRU2018-51K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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