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

NCT04655703 | Terminated Results FDA Device

• 1 other identifier: 19-0907
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Replacement

Keywords

Total Knee Replacement; Postoperative Rehabilitation; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

DJO X4 Brace with Motion Intelligence Platform: Home discharge

EXPERIMENTAL

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

Control group: Home discharge

NO INTERVENTION

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

EXPERIMENTAL

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

Control group: Discharge to rehabilitation center

NO INTERVENTION

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.

Interventions

DJO X4 brace with Motion Intelligence Platform DEVICE

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.

DJO X4 Brace with Motion Intelligence Platform: Discharge to rehabilitation center; DJO X4 Brace with Motion Intelligence Platform: Home discharge

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Syosset Hospital

Syosset, New York, 11791, United States

Location

Related Publications (1)

• 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.

  PMID: 22045067 BACKGROUND

Results Point of Contact

• Title: Eugene S. Krauss
• Organization: Northwell Health System

ekrauss@northwell.edu

516-496-2637

Study Officials

• Eugene S Krauss, MD

  Northwell Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. 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.

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 7, 2020
• Study Start: December 28, 2020
• Primary Completion: June 17, 2021
• Study Completion: June 17, 2021
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)