Degenerative ArthritisOrthosensorNCT04057885
To Determine the Gait and Functional Improvement in Total Knee Arthroplasty
A study testing Orthosensor™ VERASENSE™ Knee System in people with Degenerative Arthritis, run by LifeBridge Health at 1 site in United States.
Trial summary
This is an observational study to understand the effects of soft-tissue balancing on gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Degenerative Arthritis
- What is being tested?
- Orthosensor™ VERASENSE™ Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be a candidate for a primary PCL retaining total knee arthroplasty
- Subject must be diagnosed with one or more of the following conditions:
- osteoarthritis
- avascular necrosis
- rheumatoid or other inflammatory arthritis
- post-traumatic arthritis Minimum age: 45 Maximum age: 80
- Subject is likely to be available for all study visits
- Subject is able and willing to sign the informed consent and follow study procedures
Who cannot join
- Prior total knee arthroplasty
- ligament insufficiencies
- prior surgeries such as:
- ACL or PCL reconstructions
- posterolateral reconstructions
- osteotomies
- tibia plateau fractures
- Range of Motion less than 90 degrees f ) flexion contracture of more than 20 degrees
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
About this study
Official title: A PILOT STUDY: To Determine the Gait and Functional Improvement in Total Knee Arthroplasty With Use of Orthosensor™ VERASENSE™ Knee System for Soft Tissue Balancing.
This is an observational study to understand the effects of soft-tissue balancing on gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty
Read the detailed description
The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and to correlate Intra-operative subjective feel with OrthoSensor Outputs
Secondary objectives are to quantify and observe pain medication use, swelling, muscle strength and girth, gait efficiency, patient satisfaction, activity levels, functional return (i.e., back to work, resume normal activities) and patient perception of a balanced knee
- Conditions
- Degenerative Arthritis
- Being tested
- Orthosensor™ VERASENSE™ Knee System
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthosensor™ VERASENSE™ Knee SystemDevice
A group of patients will receive a total knee arthroplasty using the Orthosensor device
| Study group | Role | What they receive |
|---|---|---|
| Device Arm | Experimental | A prospective series of 10 patients will receive sensor-guided TKA using the this special Orthosensor™ VERASENSE™ Knee System assisted surgery for optimization of soft tissue balance Receives: Device: Orthosensor™ VERASENSE™ Knee System |
| Standard of Care | Active comparator | 10 patients will receive standard of care. Prior to cementing final implants, VERASENSE will be utilized with the standard of care group with the surgeon blinded to the data. Receives: Device: Orthosensor™ VERASENSE™ Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with improvement in gait.
Measured: 18 months
Proportion of patients not requiring long term rehabilitation.
Measured: 18 months
Proportion of patients with improved function as measured by standardized knee scores.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start15 May 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Why it stopped: Lead Investigator no longer with institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ArthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Collaborators
- Orthosensor, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael A. Mont, M.D., Principal investigator, Director, Rubin Institute for Advanced Orthopedics and Joint Preservation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057885
- Sponsor's protocol ID
- Orthosensor 101
- Acronym
- Orthosensor
- Status last verified
- Aug 2019
- First submitted
- 12 Jun 2015
- Last updated
- 26 Feb 2020
- Results posted
- No
- 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 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PILOT STUDY: To Determine the Gait and Functional Improvement in Total Knee Arthroplasty With Use of Orthosensor™ VERASENSE™ Knee System for Soft Tissue Balancing.
- ClinicalTrials.gov ID
- NCT04057885
- Acronym / sponsor ID
- Orthosensor / Orthosensor 101
- Conditions
- Degenerative Arthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lead Investigator no longer with institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Collaborators
- Orthosensor, Inc.
- Study start
- 15 May 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study to understand the effects of soft-tissue balancing on gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty
Detailed description
The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and to correlate Intra-operative subjective feel with OrthoSensor Outputs
Secondary objectives are to quantify and observe pain medication use, swelling, muscle strength and girth, gait efficiency, patient satisfaction, activity levels, functional return (i.e., back to work, resume normal activities) and patient perception of a balanced knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Arm | Experimental | Device: Orthosensor™ VERASENSE™ Knee SystemA prospective series of 10 patients will receive sensor-guided TKA using the this special Orthosensor™ VERASENSE™ Knee System assisted surgery for optimization of soft tissue balance |
| Standard of Care | Active comparator | Device: Orthosensor™ VERASENSE™ Knee System10 patients will receive standard of care. Prior to cementing final implants, VERASENSE will be utilized with the standard of care group with the surgeon blinded to the data. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must be a candidate for a primary PCL retaining total knee arthroplasty
- Subject must be diagnosed with one or more of the following conditions:
- Subject is likely to be available for all study visits
- Subject is able and willing to sign the informed consent and follow study procedures
Key exclusion criteria (8 listed)
- Prior total knee arthroplasty
- ligament insufficiencies
- prior surgeries such as:
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 |
|---|---|---|
| Orthosensor™ VERASENSE™ Knee SystemA group of patients will receive a total knee arthroplasty using the Orthosensor device | Device | Device Arm, Standard of Care |
Primary outcome
Proportion of patients with improvement in gait.
Time frame: 18 months
Proportion of patients not requiring long term rehabilitation.
Time frame: 18 months
Proportion of patients with improved function as measured by standardized knee scores.
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
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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.
Michael A. Mont, M.D. principal investigator
Director, Rubin Institute for Advanced Orthopedics and Joint Preservation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthosensor™ VERASENSE™ Knee System in people with Degenerative Arthritis, run by LifeBridge 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: withdrawn, as of the sponsor's last update on 26 Feb 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients with improvement in gait. (time frame: 18 months). The study lists 3 primary outcomes in all. 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 26 Feb 2020.