Total Knee Replacement
Conditions
Keywords
Total Knee Replacement, Postoperative Rehabilitation, Total Knee Arthroplasty
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).
Interventions
DEVICEDJO 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.
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Cohort 1- Study group-Home discharge. 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: 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. | 8 |
| Cohort 2 Cohort 2- 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. | 8 |
| Cohort 3 Cohort 3- Study group-Transfer to an inpatient rehabilitation center. 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: 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. | 0 |
| Cohort 4 Cohort 4- Control group-Transfer to an inpatient 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. | 0 |
| Total | 16 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Age, Continuous | 62 years | 61 years | 61.5 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Preoperatively and 8 weeks postoperatively
Population: The study was terminated early. In Cohort 1 only 3 patients completed the postoperative Knee Society Score. In Cohort 2 only 4 patients completed the postoperative Knee Society Score. Cohort 3 and 4 enrolled no patients.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1 | Change in the Calculated Knee Society Score | 59.7 score on a scale |
| Cohort 2 | Change in the Calculated Knee Society Score | 60.5 score on a scale |