OsteoarthritisNCT02286739
Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA)
A study testing TKA with "Verasense" and TKA without "Verasense" in people with Osteoarthritis, run by Orthosensor, Inc. at 6 sites in United States.
Trial summary
The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- TKA with "Verasense" and TKA without "Verasense"
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2015to May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who meet the indications for use for Triathlon® Total Knee System using VERASENSE™
- Subject must be diagnosed with one or more of the following conditions
- osteoarthritis
- rheumatoid or other inflammatory arthritis
- post-traumatic arthritis
- 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
- Avascular Necrosis
- Any knee surgery other than meniscectomy (can be arthroscopic or open)
- Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- Ipsilateral foot/ankle and hip arthritis
- Range of motion less than 90°, flexion contracture greater than 20°
- 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)
- Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30329
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Illinois Bone & Joint Institute
Morton Grove, Illinois, 60053
NYU Hospital for Joint Diseases
New York, New York, 10003
Virginia Commonwealth University
Richmond, Virginia, 23284
The Cleveland Clinic Foundation
Weston, Florida, 33331
About this study
Official title: Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty
The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients with a combined axial rotation couple at the tibiofemoral joint and quantitative intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to measure post-operative alignment and to evaluate the prevalence and location of radiolucency and/or osteolysis.
Read the detailed description
Hypothesis: TKA with VERASENSE results in a more reliable and precise option for establishing implant-to-implant congruency and joint balance leading to less knee pain, faster return to normal activities and higher patient satisfaction compared to TKA without VERASENSE.
- Conditions
- Osteoarthritis
- Being tested
- TKA with "Verasense", TKA without "Verasense"
- Keywords
- Total Knee Arthroplasty, Rotational Alignment, Intraoperative Sensors, Patient Outcomes, Soft Tissue Balance
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKA with "Verasense"Device
VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA pre-market submission (510K) clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
TKA without "Verasense"Procedure or surgery
TKA will be performed manually without the use of Verasense
| Study group | Role | What they receive |
|---|---|---|
| Group A TKA without VERASENSE | Sham comparator | Patients who undergo primary posterior cruciate ligament (PCL)-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. Receives: Procedure: TKA without "Verasense" |
| Group B TKA with VERASENSE | Active comparator | Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. Receives: Device: TKA with "Verasense" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty
Evaluate how intra-operative sensing with VERASENSE may assist the surgeon with balancing.
A load differential of up to 15 pound (lbs) or less between the medial and lateral condyles is indicative of soft-tissue balance. A load differential more than 15 lbs is indicative for soft-tissue unbalance.
Measured: Intra-operative with trial implants in place and after completing all surgical corrections.
Secondary outcomes (3)
Knee Society Knee Scoring System
"Patient Satisfaction" is a three-question 40-point scale and has a score of 0 (not satisfied) to 40 (very satisfied) that is collected preoperatively and at each follow-up visit.
"Patient Expectations" is a five-question fifteen-point scale and has a score of 0 (low expectation) to 15 (high expectation) that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that the operation will improve their knee pain, and their ability to perform their activities of daily living and recreational activities. The post-operative questions reflect the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function.
The "functional score" is composed of four subgroups (Walking and standing, standard activities, advanced activities, discretionary activities) and has a score of 0 (poor) to 100 (excellent).
Measured: pre-operative, 6 weeks, 6 months, 1 year, 2 years
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems. The scores range from -0.59 (worst possible health state) to 1 (best possible health state).
Measured: Pre-operative, 6 weeks, 6 months, 1 year and 2 years
Forgotten Joint Score (FJS)
The FJS is based on the patients' ability to forget about a joint as a result of the treatment. The FJS assessment is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities.
Measured: 6 weeks, 6 months, 1 year, 2 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 2014 (estimated)
- Study startApr 2015
- Primary completionMay 2020
- Study completionMay 2020
Why it stopped: Expected enrollment and follow-up not met
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthosensor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Greg Golladay, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286739
- Sponsor's protocol ID
- 102
- Status last verified
- Aug 2024
- First submitted
- 31 Oct 2014
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02286739
- Acronym / sponsor ID
- 102
- Conditions
- Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Rotational Alignment, Intraoperative Sensors, Patient Outcomes, Soft Tissue Balance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Expected enrollment and follow-up not met
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Orthosensor, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients with a combined axial rotation couple at the tibiofemoral joint and quantitative intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to measure post-operative alignment and to evaluate the prevalence and location of radiolucency and/or osteolysis.
Detailed description
Hypothesis: TKA with VERASENSE results in a more reliable and precise option for establishing implant-to-implant congruency and joint balance leading to less knee pain, faster return to normal activities and higher patient satisfaction compared to TKA without VERASENSE.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A TKA without VERASENSE | Sham comparator | Procedure: TKA without "Verasense"Patients who undergo primary posterior cruciate ligament (PCL)-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. |
| Group B TKA with VERASENSE | Active comparator | Device: TKA with "Verasense"Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who meet the indications for use for Triathlon® Total Knee System using VERASENSE™
- Subject must be diagnosed with one or more of the following conditions
- osteoarthritis
- rheumatoid or other inflammatory arthritis
- post-traumatic arthritis
Key exclusion criteria (8 listed)
- Prior Total Knee Arthroplasty
- Avascular Necrosis
- Any knee surgery other than meniscectomy (can be arthroscopic or open)
- Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
- Ipsilateral foot/ankle and 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 |
|---|---|---|
| TKA with "Verasense"VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA pre-market submission (510K) clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use. | Device | Group B TKA with VERASENSE |
| TKA without "Verasense"TKA will be performed manually without the use of Verasense | Procedure or surgery | Group A TKA without VERASENSE |
Primary outcome
Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty
Time frame: Intra-operative with trial implants in place and after completing all surgical corrections.
Evaluate how intra-operative sensing with VERASENSE may assist the surgeon with balancing. A load differential of up to 15 pound (lbs) or less between the medial and lateral condyles is indicative of soft-tissue balance. A load differential more than 15 lbs is indicative for soft-tissue unbalance.
3 secondary outcomes
Knee Society Knee Scoring System
Time frame: pre-operative, 6 weeks, 6 months, 1 year, 2 years
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
Time frame: Pre-operative, 6 weeks, 6 months, 1 year and 2 years
Forgotten Joint Score (FJS)
Time frame: 6 weeks, 6 months, 1 year, 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- 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.
Greg Golladay, MD principal investigator
Virginia Commonwealth University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TKA with "Verasense" and TKA without "Verasense" in people with Osteoarthritis, run by Orthosensor, Inc. at 6 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 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 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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 19 Aug 2024). 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?
Number of Participants With Quantitatively Balanced and Unbalanced Knees in Primary Unilateral Total Knee Arthroplasty (time frame: Intra-operative with trial implants in place and after completing all surgical corrections.). 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 19 Aug 2024.