Trial Outcomes & Findings for Use of the DJO Brace With the Motion Intelligence Platform in the Postoperative Total Knee Arthroplasty Patient (NCT NCT04655703)
NCT ID: NCT04655703
Last Updated: 2022-11-14
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Preoperatively and 8 weeks postoperatively
Results posted on
2022-11-14
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
0
|
0
|
|
Overall Study
COMPLETED
|
5
|
8
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=8 Participants
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.
|
Cohort 2
n=8 Participants
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.
|
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.
|
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.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=8 Participants
|
61 years
n=8 Participants
|
—
|
—
|
61.5 years
n=16 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
—
|
—
|
6 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
—
|
—
|
10 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Preoperatively and 8 weeks postoperativelyPopulation: 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.
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.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
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.
|
Cohort 2
n=4 Participants
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.
|
|---|---|---|
|
Change in the Calculated "Knee Society Score"
|
59.7 score on a scale
Interval 50.0 to 78.0
|
60.5 score on a scale
Interval 34.0 to 83.0
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place