Intraoperative Soft Tissue Balance in TKA

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006274
• Other study ID #: IRU2018-51K
• Status: Recruiting
• Start date: August 13, 2021
• Est. completion date: December 2023

Study information

• Verified date: August 2021
• Source: Washington Hospital Healthcare System
• Contact: Alexander Sah, MD
• Phone: 510-818-7200
• Email: info[@]SahOrtho.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• Persona Trabecular Metal Tibia
Total knee arthroplasty
• Verasense technology
Instrumented tibial trial component
• MUVR
Knee motion and gait sensing wearable device

Locations

Country	Name	City	State
United States	Washington Hospital	Fremont	California

Sponsors (2)

Lead Sponsor	Collaborator
Washington Hospital Healthcare System	Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active and passive range of motion	Flexion and extension measurements of knee	2 weeks
Primary	Active and passive range of motion	Flexion and extension measurements of knee	6 weeks
Primary	Active and passive range of motion	Flexion and extension measurements of knee	12 weeks
Primary	Active and passive range of motion	Flexion and extension measurements of knee	1 year
Primary	Implant alignment	Radiographic assessments	2 weeks post-operatively
Primary	Implant alignment	Radiographic assessments	6 weeks post-operatively
Primary	Implant alignment	Radiographic assessments	12 weeks post-operatively
Primary	Implant alignment	Radiographic assessments	1 year post-operatively
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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