Total Joint Replacement SurgeryNCT03776357
A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement
A study testing VERA clinic in people with Total Joint Replacement Surgery, run by Derek Amanatullah at 1 site in United States.
Trial summary
This is the research study of a rehabilitation tool that informs, guides and empowers clinicians to care for their patients. We hope to learn ways to improve patient outcomes, reduce costs and increase value to the healthcare system Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Total Joint Replacement Surgery
- What is being tested?
- VERA clinic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2019to 10 Mar 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for Primary unilateral total joint replacement
- Patient age should be more than or equal to 18 years.
- Patient must speak English
Who cannot join
- Patients undergoing bilateral primary knee replacement surgery
- Patients undergoing revision knee replacement surgery
- No uncorrectable deformity
- No deformity greater than 15 degree
- No hip arthritis
- No wheelchair dependency
- Patients not willing and capable to sign the written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford outpatient center
Redwood City, California, 94063
About this study
This is the research study of a rehabilitation tool that informs, guides and empowers clinicians to care for their patients. We hope to learn ways to improve patient outcomes, reduce costs and increase value to the healthcare system
Read the detailed description
The investigator hope to learn co-relation between the rehab tool and clinical findings and analyse association if any. Rehab tool will optimize care according to the patient's specific needs and provided insights to patients length of stay in the hospital. these data driven insights will be used to observe correlation between machine and clinic data
- Conditions
- Total Joint Replacement Surgery
- Being tested
- VERA clinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERA clinicDevice
A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic and at home.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The application used is build upon the company's category-defining, FDA- cleared Virtual Exercise Rehabilitation Assistant (VERA™) and create a platform that streamlines the performance and management of post-acute care physical therapy. The rehab tool will provide us with functional outcome score. Receives: Device: VERA clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay in Hospital Through Discharge
Measured: Up to 2 days
Secondary outcomes (3)
Number of Participants Requiring Gait Aid Use
The gait aide use ranges in the order of decreasing performance as Nothing > Cane > crutch > walker.
Measured: 3 months post operative visit
Knee Society Score (KSS)
To assess the effectiveness of the device by calculating knee society score (KSS) after surgery. The scale ranges from 0-100 with grading as Score 80-100 - Excellent Score 70-79 - Good Score 60-69 - Fair Score below 60 - Poor
Measured: 3 months post operative visit
Knee Range of Motion
To assess the effectiveness of the device by calculating range of motion (maximum degrees)
Measured: 3 months post operative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start26 Aug 2019
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Why it stopped: funding halted
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.
- Other trials for Total Joint Replacement SurgeryStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derek Amanatullah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Derek Amanatullah, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776357
- Sponsor's protocol ID
- 46061
- Status last verified
- Jun 2022
- First submitted
- 10 Dec 2018
- Last updated
- 30 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement
- ClinicalTrials.gov ID
- NCT03776357
- Acronym / sponsor ID
- 46061
- Conditions
- Total Joint Replacement Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding halted
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Derek AmanatullahUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Posted 30 Jun 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 the research study of a rehabilitation tool that informs, guides and empowers clinicians to care for their patients. We hope to learn ways to improve patient outcomes, reduce costs and increase value to the healthcare system
Detailed description
The investigator hope to learn co-relation between the rehab tool and clinical findings and analyse association if any. Rehab tool will optimize care according to the patient's specific needs and provided insights to patients length of stay in the hospital. these data driven insights will be used to observe correlation between machine and clinic data
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: VERA clinicThe application used is build upon the company's category-defining, FDA- cleared Virtual Exercise Rehabilitation Assistant (VERA™) and create a platform that streamlines the performance and management of post-acute care physical therapy. The rehab tool will provide us with functional outcome score. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient scheduled for Primary unilateral total joint replacement
- Patient age should be more than or equal to 18 years.
- Patient must speak English
Key exclusion criteria (7 listed)
- Patients undergoing bilateral primary knee replacement surgery
- Patients undergoing revision knee replacement surgery
- No uncorrectable deformity
- No deformity greater than 15 degree
- No hip arthritis
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 |
|---|---|---|
| VERA clinicA software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic and at home. | Device | Experimental |
Primary outcome
Length of Stay in Hospital Through Discharge
Time frame: Up to 2 days
3 secondary outcomes
Number of Participants Requiring Gait Aid Use
Time frame: 3 months post operative visit
Knee Society Score (KSS)
Time frame: 3 months post operative visit
Knee Range of Motion
Time frame: 3 months post operative visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VERA clinic in people with Total Joint Replacement Surgery, run by Derek Amanatullah 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 3 inclusion and 7 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 30 Jun 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 30 Jun 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?
Length of Stay in Hospital Through Discharge (time frame: Up to 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2022.