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

NCT ID: NCT04655703

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-28
• Study Completion Date: 2021-06-17

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.

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).

Conditions

Total Knee Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

DJO X4 brace with Motion Intelligence Platform

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

DJO X4 brace with Motion Intelligence Platform

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugene S Krauss, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health System

Locations

Syosset Hospital

Syosset, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22045067 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-0907

Identifier Type: -

Identifier Source: org_study_id