Clinical trial NCT04655703: Use of the DJO Brace With the Motion Intelligence Platform in the Postoperative Total Knee Arthroplasty Patient
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Total Knee Replacement
Keywords: Total Knee Replacement
Postoperative Rehabilitation
Total Knee Arthroplasty
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in the Calculated "Knee Society Score"
timeFrame: Preoperatively and 8 weeks postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Syosset
country: United States
facility: Syosset Hospital
state: New York
Study officials:
affiliation: Northwell Health System
name: Eugene S Krauss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.