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

Not Applicable

Terminated

Conditions: Total Knee Replacement

Interventions: Device: DJO X4 brace with Motion Intelligence Platform

Registration Number: NCT04655703

Lead Sponsor: Northwell Health

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).

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 16

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in the Calculated "Knee Society Score"	Preoperatively and 8 weeks postoperatively	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.

Secondary Outcome Measures