Total Knee ReplacementNCT04655703
Use of the DJO Brace With the Motion Intelligence Platform in the Postoperative Total Knee Arthroplasty Patient
A study testing DJO X4 brace with Motion Intelligence Platform in people with Total Knee Replacement, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- DJO X4 brace with Motion Intelligence Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2020to 17 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- DJO X4 brace with Motion Intelligence Platform
- Keywords
- Total Knee Replacement, Postoperative Rehabilitation, Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DJO X4 brace with Motion Intelligence PlatformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DJO X4 Brace with Motion Intelligence Platform: Home discharge | Experimental | Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform. Receives: Device: DJO X4 brace with Motion Intelligence Platform |
| Control group: Home discharge | No intervention | 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 | Experimental | Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform. Receives: Device: DJO X4 brace with Motion Intelligence Platform |
| Control group: Discharge to rehabilitation center | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperatively and 8 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start28 Dec 2020
- Primary completion17 Jun 2021
- Study completion17 Jun 2021
Why it stopped: Discharge to a sub-acute rehabilitation after arthroplasty surgery is discouraged after due to the pandemic. The protocol is being revised to remove this arm of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugene S Krauss, MD, Principal investigator, Northwell Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655703
- Sponsor's protocol ID
- 19-0907
- Status last verified
- Oct 2022
- First submitted
- 23 Nov 2020
- Last updated
- 14 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22045067
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04655703
- Acronym / sponsor ID
- 19-0907
- Conditions
- Total Knee Replacement
- Keywords
- Total Knee Replacement, Postoperative Rehabilitation, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discharge to a sub-acute rehabilitation after arthroplasty surgery is discouraged after due to the pandemic. The protocol is being revised to remove this arm of the study.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| DJO X4 Brace with Motion Intelligence Platform: Home discharge | Experimental | Device: DJO X4 brace with Motion Intelligence PlatformPatients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform. |
| Control group: Home discharge | No intervention | –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 | Experimental | Device: DJO X4 brace with Motion Intelligence PlatformPatients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform. |
| Control group: Discharge to rehabilitation center | No intervention | –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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DJO X4 brace with Motion Intelligence PlatformThe 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. | Device | DJO X4 Brace with Motion Intelligence Platform: Discharge to rehabilitation center, DJO X4 Brace with Motion Intelligence Platform: Home discharge |
Primary outcome
Change in the Calculated "Knee Society Score"
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22045067Scuderi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene S Krauss, MD principal investigator
Northwell Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DJO X4 brace with Motion Intelligence Platform in people with Total Knee Replacement, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Calculated "Knee Society Score" (time frame: Preoperatively and 8 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04655703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.