Use of the DJO Brace With the Motion Intelligence Platform in the Postoperative Total Knee Arthroplasty Patient

A Phase 4, Prospective, Randomized Trial to Evaluate Postoperative Outcomes in Total Knee Arthroplasy Patients Using the DJO X4 Brace With the Motion Intelligence Platform

This is a single center, investigator initiated clinical trial using a FDA approved, marketed brace called DJO X4. This phase 4, prospective, randomized clinical trial is being conducted to evaluate the use of the X4 knee brace with the Motion Intelligence platform in patients having unilateral TKA. The study is designed to determine if using a "virtual rehabilitation" device leads to enhanced recovery following TKA by improving patient objective and subjective outcome measures.

Study Overview

• Status: Terminated
• Conditions: Total Knee Replacement
• Intervention / Treatment: Device: DJO X4 brace with Motion Intelligence Platform

Detailed Description

This is a prospective, randomized clinical trial to evaluate the use of the X4 knee brace with the Motion Intelligence platform in patients having unilateral TKA. This brace is a FDA approved, marketed product being used as per the manufacturer's (DJO) marketed indications. This study is designed to determine if using a "virtual rehabilitation" device leads to enhanced recovery following total knee arthroplasty by improving patient objective and subjective outcome measures. These outcomes will be collected using a validated tool called the Knee Society Score (KSS). The KSS is a standard of care tool collected for all TKA patients pre-operatively and postoperatively at the 8 week visit.

Patients will be randomized to one to 4 cohorts:

DJO X4 Brace with Motion Intelligence Platform: Home discharge-Home. Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform.

Control group-Home discharge. Patients randomized to this group will serve as the control group. There will be no changes to the standard of care recovery for a TKA patient.

DJO X4 Brace with Motion Intelligence Platform: Discharge to rehabilitation center. Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform.

Cohort 4- Control group: Discharge to rehabilitation center. Patients randomized to this group will serve as the control group. There will be no changes to the standard of care recovery for a TKA patient.

The DJO X4 brace will be provided to the patient at no cost. Study visits, hospitalization, inpatient and outpatient rehabilitation costs are standard of care and will be the responsibility of the patient. There will be no payment for participation in this study.

All study patients will complete a daily "Daily Patient Log" starting the day after discharge from the hospital until postoperative day (POD) 56. This log will document the patient's location:

• Rehabilitation center or
• Home physical therapy or
• Physical therapy center
• Hospital (re-admission)
• Return to work (if applicable)

The study hypotheses is that the X4 brace with the Motion Intelligence platform will provide an enhanced, cost-effective postoperative recovery following total knee arthroplasty (TKA).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Syosset, New York, United States, 11791
      • Syosset Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 or < 90
• Able to read and speak in English
• Patients having a unilateral total knee arthroplasty by Drs. Krauss or Segal
• Patients with a smart phone and internet able to access the Motion Intelligence Platform
• Patient is freely able to provide consent
• Patients willing to comply with the standard of care postoperative visit schedule (2 and 8 weeks)
• Agree to complete the KSS 2013 version preoperatively and at the 8 week postoperative visit
• Agree to complete the study required validated System Usability Scale at the 8 week postoperative visit

Exclusion Criteria

• Surgery covered by workman's compensation
• Physical impairments which in the opinion of the surgeon will effect or limit rehabilitation (e.g.: Multiple Sclerosis, Parkinson's disease)
• Limited mobility preoperatively requiring the use of a wheelchair
• Chronic opioid use prior to surgery
• Alcohol abuse
• Participation in another clinical trial
• Cognitive limitations which will interfere with the understanding of the Motion Intelligence platform
• Requirement for a knee immobilizer postoperatively

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DJO X4 Brace with Motion Intelligence Platform: Home discharge; Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform.	Device: DJO X4 brace with Motion Intelligence Platform; The X4 Knee brace with the Motion Intelligence platform uses both a bio-measurement equipment with an interactive application thereby providing the patient with immediate feedback on their exercise regime. The X4 Knee brace is a postoperative brace worn by a patient to monitor compliance to prescribed protocol based on the movement and function of the knee joint. The device also connects wirelessly to a companion mobile application, Motion Intelligence, and streams both real-time and collected data for review and record collection. Prescribed exercises are uploaded into the patient application, with a number of the exercises actively tracked by the Mi360 sensor housed in the X4 brace. Compliance can be tracked by the physician in real-time between postoperative visits and any medical staff on a separate dashboard.
NO_INTERVENTION: Control group: Home discharge; Patients randomized to this group will serve as the control group. There will be no changes to the standard of care recovery for a TKA patient.
EXPERIMENTAL: DJO X4 Brace with Motion Intelligence Platform: Discharge to rehabilitation center; Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform.	Device: DJO X4 brace with Motion Intelligence Platform; The X4 Knee brace with the Motion Intelligence platform uses both a bio-measurement equipment with an interactive application thereby providing the patient with immediate feedback on their exercise regime. The X4 Knee brace is a postoperative brace worn by a patient to monitor compliance to prescribed protocol based on the movement and function of the knee joint. The device also connects wirelessly to a companion mobile application, Motion Intelligence, and streams both real-time and collected data for review and record collection. Prescribed exercises are uploaded into the patient application, with a number of the exercises actively tracked by the Mi360 sensor housed in the X4 brace. Compliance can be tracked by the physician in real-time between postoperative visits and any medical staff on a separate dashboard.
NO_INTERVENTION: Control group: Discharge to rehabilitation center; Patients randomized to this group will serve as the control group. There will be no changes to the standard of care recovery for a TKA patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Calculated "Knee Society Score"	Functional outcomes measured by the 2011 "Knee Society Score". The Functional Activities section consists of 4 sub-sections with a total score ranging from 0-100 points. The higher the numerical value the better the outcome. The sub-sections consist of: (1)Walking and Standing 0-30 points (2)Standard Activities 0-30 points (3)Advanced Activities 0-25 points (4)Discretionary Knee Activities 0-15 points.	Preoperatively and 8 weeks postoperatively

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Eugene S Krauss, MD, Northwell Health System

Publications and helpful links

General Publications

• Scuderi GR, Bourne RB, Noble PC, Benjamin JB, Lonner JH, Scott WN. The new Knee Society Knee Scoring System. Clin Orthop Relat Res. 2012 Jan;470(1):3-19. doi: 10.1007/s11999-011-2135-0. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 28, 2020
• Primary Completion (ACTUAL): June 17, 2021
• Study Completion (ACTUAL): June 17, 2021

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (ACTUAL): December 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Total Knee Replacement; Postoperative Rehabilitation
• Other Study ID Numbers: 19-0907

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.: No