Knee OsteoarthritisNCT03023410
Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by Orthosensor, Inc. at 1 site in United States.
Trial summary
This study will attempt to draw relationships between the soft-tissue related complications contributing to early TKA revision and the loading and positional patterns from intraoperative tibial trial sensors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- VERASENSE
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2018to 16 Jul 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are candidates for revision TKA and meet all inclusion and no exclusion will be offered study participation without regard to race, sex, economic status, or religious belief.
Who may be able to join
- Patients undergoing revision unilateral total knee arthroplasty within the first 5-years of the index procedure
- Include Male and Female subjects
- Include subjects 18 years and older
- Patients should present with idiopathic pain and/or instability/stiffness attributed to aseptic loosening, polyethylene wear or malrotation
- Patients able to understand study intent, and agree to study participation
- Patients must be previously implanted with the following cruciate-retaining (CR) or posterior-substituting (PS) total knee systems: Stryker TRIATHLON, Zimmer-Biomet VANGUARD or NEXGEN or Smith and Nephew LEGION or JOURNEY II.
Who cannot join
- No prior revision surgery on operative side
- Ligament insufficiencies, prior surgeries such as PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- Culture positive aspiration indicating infection of the joint
- ASA class > III
- History of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Holy Cross Hospital, Orthopedic Institute
Fort Lauderdale, Florida, 33334
About this study
This study will attempt to draw relationships between the soft-tissue related complications contributing to early TKA revision and the loading and positional patterns from intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to address such soft-tissue abnormalities that may otherwise be unknown during traditional total knee revision procedures. The utilization of sensors should in theory, help diagnose the potential causes attributing to soft-tissue imbalance and may lead to a decreased need for an all component revision. Furthermore, the economic implications from converting a total revision to a partial revision could have a profound effect to the patient and healthcare provider such as decreased rehabilitation regimes and opportunity for cost savings. Eligible revision patients who agree to participate will be followed for a period of 12 months following the revision procedure. Patient reported outcomes measures (PROM) such as the 2011 Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey (VR-12) will be collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12 months post-procedure. All outcomes will be scored to observe changes from baseline at 12-months. Cost-analyses of sensor-assisted revision TKA will be performed to include OR costs, facility and physician fees, as well as payments to post-acute collaborators such as SNFs, rehab hospitals, PT and home care providers. A quantitative analysis of commercial payer claims / usage data (e.g., CMS Medpar data) will be used to examine costs associated with traditional revision TKA procedures.
- Conditions
- Knee Osteoarthritis
- Being tested
- VERASENSE
- Keywords
- Revision TKA, Instability, Stiffness, Aseptic Loosening, Polyethylene Wear, Malrotation, Soft Tissue Imbalance
- Medical subject headings
- Osteoarthritis, Knee, Volvulus Of Midgut
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERASENSEProcedure or surgery
Also called Sensor-Assisted TKA
Sensor-Assisted Revision TKA
| Study group | Role | What they receive |
|---|---|---|
| Partial Revision | A "partial" revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component. Receives: Procedure: VERASENSE | |
| Total Revision | A "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner). Receives: Procedure: VERASENSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cause of Early TKA Revision
The objective is to evaluate and link the possible causes of early TKA revision procedures using intraoperative sensors in effort to understand why knees fail in addition to examining the economic implications to the patient and hospital.
Measured: 12-months
Secondary outcomes (2)
Knee Society Score
This survey is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs. Patient expectations as well as patient satisfaction are also evaluated.
Measured: 12 months
Veterans Rand 12-Item Health Survey
This survey is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue , social functioning and mental health
Measured: Change from Baseline at 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start17 Jan 2018
- Primary completion16 Jul 2018
- Study completion16 Jul 2018
Why it stopped: limited eligible population
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 Knee OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthosensor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Leone, MD, Principal investigator, Holy Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023410
- Sponsor's protocol ID
- Revision TKA Study
- Status last verified
- Jun 2024
- First submitted
- 10 Jan 2017
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03023410
- Acronym / sponsor ID
- Revision TKA Study
- Conditions
- Knee Osteoarthritis
- Keywords
- Revision TKA, Instability, Stiffness, Aseptic Loosening, Polyethylene Wear, Malrotation, Soft Tissue Imbalance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: limited eligible population
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Orthosensor, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Posted 29 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will attempt to draw relationships between the soft-tissue related complications contributing to early TKA revision and the loading and positional patterns from intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to address such soft-tissue abnormalities that may otherwise be unknown during traditional total knee revision procedures. The utilization of sensors should in theory, help diagnose the potential causes attributing to soft-tissue imbalance and may lead to a decreased need for an all component revision. Furthermore, the economic implications from converting a total revision to a partial revision could have a profound effect to the patient and healthcare provider such as decreased rehabilitation regimes and opportunity for cost savings. Eligible revision patients who agree to participate will be followed for a period of 12 months following the revision procedure. Patient reported outcomes measures (PROM) such as the 2011 Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey (VR-12) will be collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12 months post-procedure. All outcomes will be scored to observe changes from baseline at 12-months. Cost-analyses of sensor-assisted revision TKA will be performed to include OR costs, facility and physician fees, as well as payments to post-acute collaborators such as SNFs, rehab hospitals, PT and home care providers. A quantitative analysis of commercial payer claims / usage data (e.g., CMS Medpar data) will be used to examine costs associated with traditional revision TKA procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Revision | – | Procedure: VERASENSEA "partial" revision will be indicated when only the tibial liner is changed or only the tibial liner with the tibial tray or only the tibial liner with the femoral component. |
| Total Revision | – | Procedure: VERASENSEA "total" revision will be indicated when all components are completely removed and replaced (tibial tray, femoral component and tibial liner). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are candidates for revision TKA and meet all inclusion and no exclusion will be offered study participation without regard to race, sex, economic status, or religious belief.
Key inclusion criteria (6 listed)
- Patients undergoing revision unilateral total knee arthroplasty within the first 5-years of the index procedure
- Include Male and Female subjects
- Include subjects 18 years and older
- Patients should present with idiopathic pain and/or instability/stiffness attributed to aseptic loosening, polyethylene wear or malrotation
- Patients able to understand study intent, and agree to study participation
Key exclusion criteria (5 listed)
- No prior revision surgery on operative side
- Ligament insufficiencies, prior surgeries such as PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- Culture positive aspiration indicating infection of the joint
- ASA class > III
- History of drug or 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 |
|---|---|---|
| VERASENSEAlso: Sensor-Assisted TKASensor-Assisted Revision TKA | Procedure or surgery | Partial Revision, Total Revision |
Primary outcome
Cause of Early TKA Revision
Time frame: 12-months
The objective is to evaluate and link the possible causes of early TKA revision procedures using intraoperative sensors in effort to understand why knees fail in addition to examining the economic implications to the patient and hospital.
2 secondary outcomes
Knee Society Score
Time frame: 12 months
Veterans Rand 12-Item Health Survey
Time frame: Change from Baseline at 12-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- 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.
William Leone, MD principal investigator
Holy Cross Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Orthosensor, Inc. 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 6 inclusion and 5 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 29 Jan 2025. 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 29 Jan 2025). 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?
Cause of Early TKA Revision (time frame: 12-months). 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 29 Jan 2025.