NCT05006274

Intraoperative Soft Tissue Balance in TKA

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Washington Hospital Healthcare System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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)

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Persona Trabecular Metal Tibia	Total knee arthroplasty
DEVICE	Verasense technology	Instrumented tibial trial component
DEVICE	MUVR	Knee motion and gait sensing wearable device

Timeline

• Start date: 2021-08-13
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2021-08-16
• Last updated: 2021-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study