Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic ArthritisNCT01469299
Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System
An observational study of Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, run by Orthosensor, Inc. at 8 sites in United States.
Trial summary
The primary objectives of this evaluation are: 1) To attempt to refine the current clinical understanding of "balance" 2) To determine if patients with quantifiably balanced knee joints exhibit improved clinical outcomes versus patient with residual imbalance, as measured by the VERASENSE™ Knee System Secondary… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis
- How many people
- 285 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2011to Dec 2016
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Subject must be a candidate for a primary total knee replacement
- Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis post-traumatic arthritis
- Subject's joint must be anatomically and functionally suited to receive the selected implant
- Subject is 50 years of age or older (≥ 50 yrs) at the time of consent
- Subject is likely to be available for all study visits
- Subject is able and willing to sign the informed consent and follow study procedures
- Subject is not pregnant
Who cannot join
- Prior total knee arthroplasty
- Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is pregnant
- Subject has an active infection or joint sepsis
- Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints)
- Ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory Healthcare - St. Joseph's Research Institute
Atlanta, Georgia, 30342
Holy Cross Orthopedic Institute
Fort Lauderdale, Florida, 33334
Spectrum Health/Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49525
University of Wisconsin
Madison, Wisconsin, 53705
Naples Community Hospital
Naples, Florida, 34102
Trinity Health/Bone and Joint Institute
Port Huron, Michigan, 48060
St. Helena Hospital
St. Helena, California, 94574
Tampa General/FORE
Tampa, Florida, 33637
About this study
The primary objectives of this evaluation are: 1) To attempt to refine the current clinical understanding of "balance" 2) To determine if patients with quantifiably balanced knee joints exhibit improved clinical outcomes versus patient with residual imbalance, as measured by the VERASENSE™ Knee System
Secondary objectives:
- Determine whether a difference in inter-compartment loads and soft tissue tension exists between the physicians intra-operative feel compared to the quantifiable data measured by the VERASENSE™ Knee System
- Determine which ligament releases are performed by the surgeon to improve soft tissue balance while utilizing the information from the VERASENSE™ Knee System
- Evaluate range of motion, pain, physical function, activity level, and patient satisfaction between baseline (pre-operative) and post-operative follow-up as well as radiographic success and survivorship of the knee implants
- Keywords
- Ligament Balance, Total Knee Arthroplasty, Intra-operative Sensors
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Balance
Measured: At time of Total Knee Surgery
Secondary outcomes (1)
Patient Reported Outcome Measures
Measured: Changes from Baseline at 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthosensor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Gustke, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469299
- Sponsor's protocol ID
- 1-Anderson
- Status last verified
- Jan 2017
- First submitted
- 8 Nov 2011
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System
- ClinicalTrials.gov ID
- NCT01469299
- Acronym / sponsor ID
- 1-Anderson
- Keywords
- Ligament Balance, Total Knee Arthroplasty, Intra-operative Sensors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Orthosensor, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Nov 2011 (estimated)
- 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.
The primary objectives of this evaluation are: 1) To attempt to refine the current clinical understanding of "balance" 2) To determine if patients with quantifiably balanced knee joints exhibit improved clinical outcomes versus patient with residual imbalance, as measured by the VERASENSE™ Knee System
Secondary objectives:
- Determine whether a difference in inter-compartment loads and soft tissue tension exists between the physicians intra-operative feel compared to the quantifiable data measured by the VERASENSE™ Knee System
- Determine which ligament releases are performed by the surgeon to improve soft tissue balance while utilizing the information from the VERASENSE™ Knee System
- Evaluate range of motion, pain, physical function, activity level, and patient satisfaction between baseline (pre-operative) and post-operative follow-up as well as radiographic success and survivorship of the knee implants
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (7 listed)
- Subject must be a candidate for a primary total knee replacement
- Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis post-traumatic arthritis
- Subject's joint must be anatomically and functionally suited to receive the selected implant
- Subject is 50 years of age or older (≥ 50 yrs) at the time of consent
- Subject is likely to be available for all study visits
Key exclusion criteria (7 listed)
- Prior total knee arthroplasty
- Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is pregnant
- Subject has an active infection or joint sepsis
- Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Joint Balance
Time frame: At time of Total Knee Surgery
1 secondary outcome
Patient Reported Outcome Measures
Time frame: Changes from Baseline at 3-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
Related trials for Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis
Active, not recruitingObservational study
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Knee Pain Chronic, Osteoarthritis, Knee
RecruitingObservational study
The Medacta International SMS Post-Marketing Surveillance Study
Arthrosis, Traumatic Arthritis
Active, not recruitingObservational study
PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty
Rheumatoid Arthritis With Adequate Bone Quality, Inflammatory Arthritis
Active, not recruiting
Persona Ti-Nidium Post-Market Clinical Follow-up
Knee Pain Chronic, Osteoarthritis
Active, not recruitingObservational study
Anatomical Shoulder Domelock System Study
Avascular Necrosis, Revision Surgery
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.
Kenneth Gustke, MD principal investigator
Florida Orthopaedic Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, run by Orthosensor, Inc. at 8 sites 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 7 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: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Joint Balance (time frame: At time of Total Knee Surgery). 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 11 Jan 2017.