Osteoarthritis, KneeNCT03628378
Orthosensor vs Conventional Total Knee Arthroplasty
A study testing Verasense in people with Osteoarthritis, Knee, run by Columbia University at 2 sites in United States.
Trial summary
In a randomized-controlled fashion, this investigation will evaluate the use of the Verasense technology to achieve optimal TKA balance. Patients will be randomized to either: 1) undergo manual soft tissue balancing or 2) soft tissue balancing with the Verasense. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Verasense
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2017to 22 Jun 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary total knee replacement
Who cannot join
- Revision knee surgery
- Prior knee surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NewYork-Presbyterian Lawrence Hospital
Bronxville, New York, 10708
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Outcomes in Free-hand Versus Sensor-guided Balancing in Total Knee Arthroplasty: a Randomized Controlled Trial
In a randomized-controlled fashion, this investigation will evaluate the use of the Verasense technology to achieve optimal TKA balance. Patients will be randomized to either: 1) undergo manual soft tissue balancing or 2) soft tissue balancing with the Verasense. The primary outcomes of interest will include patient-reported outcomes as well knee range of motion at 3 months, 6 months, 1 year, and 2 years. Secondary outcomes of interest will include pain level as assessed by the visual analogue scale (VAS) in the acute post-operative and follow up periods, ambulation distance during inpatient physical therapy postoperatively, surgical time, tourniquet time, amount of opioid consumption, length of hospital stay, incidence of arthrofibrosis and subsequent manipulation under anesthesia. The investigators hypothesize that the use of the Verasense technology will lead to improved soft tissue balancing in TKA and ultimately result in favorable patient-reported outcomes and postoperative knee range of motion.
Read the detailed description
Total knee arthroplasty (TKA) is one of the most successful surgical procedures performed worldwide, and if conducted properly, has proven to improve pain, knee range of motion, and ultimately quality of life. Approximately 700,000 TKAs are performed annually in the United States, and this number is projected to increase to 3.48 million annually by 2030. Unfortunately, roughly 20% of patients who undergo TKA are dissatisfied with their outcome and this number has remained stagnant for the past decade.Patient satisfaction after TKA is predominantly driven by postoperative pain and function.
Outcomes in TKA are influenced by multiple factors, stemming from patient-specific factors and surgically modifiable factors. Patient specific factors include body mass index (BMI), preoperative range of motion (ROM), psychological status, and other comorbidities; examples of surgically modifiable factors include the type of prosthesis utilized, posterior condylar offset, posterior tibial slope, and soft tissue balancing. Knee arthritis is a disease not only of the condylar surfaces, but of the soft tissues as well. As such, the success of a TKA depends on the ultimate restoration of the integrity of the knee articular surfaces,necessitating two critical elements, beginning with precise osteotomies and ending with soft tissue balancing to realign the lower extremity to a neutral mechanical axis.
In the last three decades, this first element has been addressed by major technological advances to perform precise and reproducible osteotomies, most recently with the development of computer-assisted navigation and validation techniques and modalities that allow osteotomies based on anatomical jigs created by CT imaging of the patient's knee.
Despite these advances, little advancement has been appreciated by the second element-soft tissue balancing.While precise osteotomies are critical to the success of a TKA, they do not address ligamentous stability and balance, which if absent, leads to knee instability, stiffness, accelerated prosthetic wear, aseptic loosening, and premature implant failure. Soft tissue imbalance accounts for 35% of early TKA revisions in the United States. Soft tissue balancing in TKA has traditionally been more of an art than a science, relying exclusively on the surgeon's subjective assessment based on nebulous tactile feedback after completion of the osteotomies. The diseased soft tissues (i.e. ligaments) may be lengthened, tightened, or released to achieve balance, range of motion, and functional stability. However, these methods are numerous, variable, and above all, highly subjective. The individual experience of the surgeon, including fellowship training and procedural volume play a role in their ability to balance a knee properly.
Typically, it is only after many years of experience does the surgeon develop the ability to accurately assess stability in varus, valgus, anterior and posterior planes.Objective balancing of soft tissues in TKA may contribute to a decrease in pain, improve function, patient satisfaction, and ultimately decrease the rate of revision. The need for the transformation of TKA soft tissue balancing from an art to a science has been realized by a technology that allows surgeons to objectively quantify ligament balance by offering real-time, evidence-based data during TKA. The Verasense (Orthosensor Inc., Dania, FL) is a disposable wireless device embedded with force sensors and inserted into the tibial component during the trialing phase of surgery after gross balancing, allowing real-time loading values in the medial and lateral compartments of the knee and fine-tuning of the end result by further soft tissue releases to improve balance and stability.
Balance in TKA is defined as stability in the sagittal plane and less than 15 pounds difference in the medial and lateral compartments of the knee. In a multicenter study, intraoperative sensors were utilized to define balance and to correlate it with improved clinical outcomes. TKAs that had undergone said balancing were compared to unbalanced TKAs, with results showing improved Knee Society Score (KSS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) between balanced (172, 14.5 points) and unbalanced (145.3, 23.8 points), respectively. The authors concluded that a well-balanced TKA was the most significant contributing factor to improved postoperative outcomes.
Similarly, Chow et al. investigated six-month patient-reported outcomes in a small retrospective cohort study with short-term follow up of six months comparing sensor-assisted to non-sensor-assisted TKA balancing. They reported that the KSS, Oxford Knee Score, and knee range of motion was significantly higher in the sensor-assisted cohort and that the rate of arthrofibrosis was lower in the sensor-assisted group, however, not statistically significant.
Further, Geller et al. retrospectively compared the incidence of arthrofibrosis before and after the implementation of the Verasense technology to assist with ligament balancing and reported a 5% rate of arthrofibrosis prior to implementation versus 1.6% after. In this same report, median length of surgery was 83 minutes before implementation compared to 115 minutes after. The authors reported that while the implantation of the sensor increased operative time, this additional time does not have a clinical impact and that the benefits outweigh this potential increase in operative time. Multiple reports in the literature have suggested that a well-balanced TKA, which leads to increased activity levels may be part of a cascade effect, which ultimately results in higher patient-reported outcome scores.
Unfortunately, soft tissue balancing is one of the only remaining aspects of TKA that has not benefited from a consensus based on quantitative measures and objective data. As the economic environment changes in medicine, coupled with a five-fold increase in TKAs performed and the subsequent need for less experienced surgeons to perform TKAs, it is imperative that the traditional subjectivity once relied upon be replaced by more empirical and clinical data to construct a scientific consensus of what balance is. In so doing, clinical outcomes may be improved, with a resultant decrease in the rate of early revisions, and ultimately significant savings in healthcare expenditures.While the literature has demonstrated a clear advantage by technology like the Verasense, previous studies have predominantly been underpowered, with short-term follow up, and unstandardized TKAs, including surgical approach, prosthetic designs, manufacturer, and above all, not randomized and controlled.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Verasense
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerasenseDevice
Also called Orthosensor
Ligamentous balancing device
| Study group | Role | What they receive |
|---|---|---|
| Non-Sensor Group | No intervention | Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology. |
| Sensor Group | Experimental | Patients will undergo total knee replacement surgery with Verasense assisted balancing technology. Receives: Device: Verasense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Score on the 12-Item Short Form Survey (SF-12) - Physical Component
SF-12 is a patient-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 is composed of a mental component score and a physical component score.
The score range for each component is 0 to 100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Measured: 3 months, 1 year, 2 years
Average Score on the 12-Item Short Form Survey (SF-12) - Mental Component
SF-12 is a patient-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 is composed of a mental component score and a physical component score.
The score range for each component is 0 to 100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Measured: 3 months, 1 year, 2 years
Average Score on the WOMAC Functional (F) Limitation Subscale
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a 24-item patient-report questionnaire used to assess pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC-F score is derived as the sum of the 17 item scores in the pain domain. It will be normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the Functional score and multiplying by 100.
Measured: 3 months, 1 year, 2 years
Average Score on the WOMAC Stiffness (S) Subscale
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a 24-item patient-report questionnaire used to assess pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC-S score is derived as the sum of the 2 item scores in the pain domain. It will be normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the Functional score and multiplying by 100.
Measured: 3 months, 1 year, 2 years
Average Score on the WOMAC Pain (P) Subscale
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a 24-item patient-report questionnaire used to assess pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC-P score is derived as the sum of the 5 item scores in the pain domain. It will be normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the Pain score and multiplying by 100.
Measured: 3 months, 1 year, 2 years
Knee Society Functional Score (KSFS)
The investigators will ask participants to answer survey questions about knee functionality on a scale of 0-100, 0 being the least functionality and 100 being the most functionality.
Measured: 3 months, 1 year, 2 years
Average Arc of Range of Motion (Extension to Flexion)
A normal range of motion is 0º extension (completely straight leg) to 130º (a fully flexed leg).
Measured: 3 months, 1 year, 2 years
Secondary outcomes (2)
Visual Analogue Scale Pain Level
Pain levels on a scale from 1-10 (1 being the least amount of pain possible and 10 being the most amount of pain possible).
Measured: 1 week
Ambulation (Distance)
ambulation distance during inpatient physical therapy (PT) postoperatively - presented in daily PT performance in feet.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start20 Dec 2017
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
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.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Geller, Columbia University
- Investigators
- Jeffrey Geller, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628378
- Sponsor's protocol ID
- AAAR6137
- Status last verified
- Sep 2024
- First submitted
- 26 Jul 2018
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Chow JC, Breslauer L. The Use of Intraoperative Sensors Significantly Increases the Patient-Reported Rate of Improvement in Primary Total Knee Arthroplasty. Orthopedics. 2017 Jul 1;40(4):e648-e651. doi: 10.3928/01477447-20170503-01. Epub 2017 May 8.
PubMed 28481384Jacobs CA, Christensen CP, Karthikeyan T. Patient and intraoperative factors influencing satisfaction two to five years after primary total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1576-9. doi: 10.1016/j.arth.2014.03.022. Epub 2014 Mar 28.
PubMed 24768544Judge A, Arden NK, Cooper C, Kassim Javaid M, Carr AJ, Field RE, Dieppe PA. Predictors of outcomes of total knee replacement surgery. Rheumatology (Oxford). 2012 Oct;51(10):1804-13. doi: 10.1093/rheumatology/kes075. Epub 2012 Apr 24.
PubMed 22532699Kim KW, Han JW, Cho HJ, Chang CB, Park JH, Lee JJ, Lee SB, Seong SC, Kim TK. Association between comorbid depression and osteoarthritis symptom severity in patients with knee osteoarthritis. J Bone Joint Surg Am. 2011 Mar 16;93(6):556-63. doi: 10.2106/JBJS.I.01344.
PubMed 21411706Camarata DA. Soft tissue balance in total knee arthroplasty with a force sensor. Orthop Clin North Am. 2014 Apr;45(2):175-84. doi: 10.1016/j.ocl.2013.12.001. Epub 2014 Feb 1.
PubMed 24684911Churchill JL, Khlopas A, Sultan AA, Harwin SF, Mont MA. Gap-Balancing versus Measured Resection Technique in Total Knee Arthroplasty: A Comparison Study. J Knee Surg. 2018 Jan;31(1):13-16. doi: 10.1055/s-0037-1608820. Epub 2017 Nov 27.
PubMed 29179222Krackow KA. Instability in total knee arthroplasty: loose as a goose. J Arthroplasty. 2003 Apr;18(3 Suppl 1):45-7. doi: 10.1054/arth.2003.50069.
PubMed 12730928Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. A new method for defining balance: promising short-term clinical outcomes of sensor-guided TKA. J Arthroplasty. 2014 May;29(5):955-60. doi: 10.1016/j.arth.2013.10.020. Epub 2013 Oct 24.
PubMed 24269069Fehring TK, Odum S, Griffin WL, Mason JB, Nadaud M. Early failures in total knee arthroplasty. Clin Orthop Relat Res. 2001 Nov;(392):315-8. doi: 10.1097/00003086-200111000-00041.
PubMed 11716402Meneghini RM, Ziemba-Davis MM, Lovro LR, Ireland PH, Damer BM. Can Intraoperative Sensors Determine the "Target" Ligament Balance? Early Outcomes in Total Knee Arthroplasty. J Arthroplasty. 2016 Oct;31(10):2181-7. doi: 10.1016/j.arth.2016.03.046. Epub 2016 Apr 4.
PubMed 27155997Incavo SJ, Wild JJ, Coughlin KM, Beynnon BD. Early revision for component malrotation in total knee arthroplasty. Clin Orthop Relat Res. 2007 May;458:131-6. doi: 10.1097/BLO.0b013e3180332d97.
PubMed 17224835Walker PS, Meere PA, Bell CP. Effects of surgical variables in balancing of total knee replacements using an instrumented tibial trial. Knee. 2014 Jan;21(1):156-61. doi: 10.1016/j.knee.2013.09.002. Epub 2013 Sep 19.
PubMed 24103411Geller JA, Lakra A, Murtaugh T. The Use of Electronic Sensor Device to Augment Ligament Balancing Leads to a Lower Rate of Arthrofibrosis After Total Knee Arthroplasty. J Arthroplasty. 2017 May;32(5):1502-1504. doi: 10.1016/j.arth.2016.12.019. Epub 2016 Dec 24.
PubMed 28109758Sarpong NO, Held MB, Grosso MJ, Herndon CL, Santos W, Lakra A, Shah RP, Cooper HJ, Geller JA. No Benefit to Sensor-guided Balancing Compared With Freehand Balancing in TKA: A Randomized Controlled Trial. Clin Orthop Relat Res. 2022 Aug 1;480(8):1535-1544. doi: 10.1097/CORR.0000000000002168. Epub 2022 Apr 7.
PubMed 35394462
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in Free-hand Versus Sensor-guided Balancing in Total Knee Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03628378
- Acronym / sponsor ID
- AAAR6137
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a randomized-controlled fashion, this investigation will evaluate the use of the Verasense technology to achieve optimal TKA balance. Patients will be randomized to either: 1) undergo manual soft tissue balancing or 2) soft tissue balancing with the Verasense. The primary outcomes of interest will include patient-reported outcomes as well knee range of motion at 3 months, 6 months, 1 year, and 2 years. Secondary outcomes of interest will include pain level as assessed by the visual analogue scale (VAS) in the acute post-operative and follow up periods, ambulation distance during inpatient physical therapy postoperatively, surgical time, tourniquet time, amount of opioid consumption, length of hospital stay, incidence of arthrofibrosis and subsequent manipulation under anesthesia. The investigators hypothesize that the use of the Verasense technology will lead to improved soft tissue balancing in TKA and ultimately result in favorable patient-reported outcomes and postoperative knee range of motion.
Detailed description
Total knee arthroplasty (TKA) is one of the most successful surgical procedures performed worldwide, and if conducted properly, has proven to improve pain, knee range of motion, and ultimately quality of life. Approximately 700,000 TKAs are performed annually in the United States, and this number is projected to increase to 3.48 million annually by 2030. Unfortunately, roughly 20% of patients who undergo TKA are dissatisfied with their outcome and this number has remained stagnant for the past decade.Patient satisfaction after TKA is predominantly driven by postoperative pain and function.
Outcomes in TKA are influenced by multiple factors, stemming from patient-specific factors and surgically modifiable factors. Patient specific factors include body mass index (BMI), preoperative range of motion (ROM), psychological status, and other comorbidities; examples of surgically modifiable factors include the type of prosthesis utilized, posterior condylar offset, posterior tibial slope, and soft tissue balancing. Knee arthritis is a disease not only of the condylar surfaces, but of the soft tissues as well. As such, the success of a TKA depends on the ultimate restoration of the integrity of the knee articular surfaces,necessitating two critical elements, beginning with precise osteotomies and ending with soft tissue balancing to realign the lower extremity to a neutral mechanical axis.
In the last three decades, this first element has been addressed by major technological advances to perform precise and reproducible osteotomies, most recently with the development of computer-assisted navigation and validation techniques and modalities that allow osteotomies based on anatomical jigs created by CT imaging of the patient's knee.
Despite these advances, little advancement has been appreciated by the second element-soft tissue balancing.While precise osteotomies are critical to the success of a TKA, they do not address ligamentous stability and balance, which if absent, leads to knee instability, stiffness, accelerated prosthetic wear, aseptic loosening, and premature implant failure. Soft tissue imbalance accounts for 35% of early TKA revisions in the United States. Soft tissue balancing in TKA has traditionally been more of an art than a science, relying exclusively on the surgeon's subjective assessment based on nebulous tactile feedback after completion of the osteotomies. The diseased soft tissues (i.e. ligaments) may be lengthened, tightened, or released to achieve balance, range of motion, and functional stability. However, these methods are numerous, variable, and above all, highly subjective. The individual experience of the surgeon, including fellowship training and procedural volume play a role in their ability to balance a knee properly.
Typically, it is only after many years of experience does the surgeon develop the ability to accurately assess stability in varus, valgus, anterior and posterior planes.Objective balancing of soft tissues in TKA may contribute to a decrease in pain, improve function, patient satisfaction, and ultimately decrease the rate of revision. The need for the transformation of TKA soft tissue balancing from an art to a science has been realized by a technology that allows surgeons to objectively quantify ligament balance by offering real-time, evidence-based data during TKA. The Verasense (Orthosensor Inc., Dania, FL) is a disposable wireless device embedded with force sensors and inserted into the tibial component during the trialing phase of surgery after gross balancing, allowing real-time loading values in the medial and lateral compartments of the knee and fine-tuning of the end result by further soft tissue releases to improve balance and stability.
Balance in TKA is defined as stability in the sagittal plane and less than 15 pounds difference in the medial and lateral compartments of the knee. In a multicenter study, intraoperative sensors were utilized to define balance and to correlate it with improved clinical outcomes. TKAs that had undergone said balancing were compared to unbalanced TKAs, with results showing improved Knee Society Score (KSS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) between balanced (172, 14.5 points) and unbalanced (145.3, 23.8 points), respectively. The authors concluded that a well-balanced TKA was the most significant contributing factor to improved postoperative outcomes.
Similarly, Chow et al. investigated six-month patient-reported outcomes in a small retrospective cohort study with short-term follow up of six months comparing sensor-assisted to non-sensor-assisted TKA balancing. They reported that the KSS, Oxford Knee Score, and knee range of motion was significantly higher in the sensor-assisted cohort and that the rate of arthrofibrosis was lower in the sensor-assisted group, however, not statistically significant.
Further, Geller et al. retrospectively compared the incidence of arthrofibrosis before and after the implementation of the Verasense technology to assist with ligament balancing and reported a 5% rate of arthrofibrosis prior to implementation versus 1.6% after. In this same report, median length of surgery was 83 minutes before implementation compared to 115 minutes after. The authors reported that while the implantation of the sensor increased operative time, this additional time does not have a clinical impact and that the benefits outweigh this potential increase in operative time. Multiple reports in the literature have suggested that a well-balanced TKA, which leads to increased activity levels may be part of a cascade effect, which ultimately results in higher patient-reported outcome scores.
Unfortunately, soft tissue balancing is one of the only remaining aspects of TKA that has not benefited from a consensus based on quantitative measures and objective data. As the economic environment changes in medicine, coupled with a five-fold increase in TKAs performed and the subsequent need for less experienced surgeons to perform TKAs, it is imperative that the traditional subjectivity once relied upon be replaced by more empirical and clinical data to construct a scientific consensus of what balance is. In so doing, clinical outcomes may be improved, with a resultant decrease in the rate of early revisions, and ultimately significant savings in healthcare expenditures.While the literature has demonstrated a clear advantage by technology like the Verasense, previous studies have predominantly been underpowered, with short-term follow up, and unstandardized TKAs, including surgical approach, prosthetic designs, manufacturer, and above all, not randomized and controlled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Sensor Group | No intervention | –Patients will undergo standard total knee replacement surgery without Verasense assisted balancing technology. |
| Sensor Group | Experimental | Device: VerasensePatients will undergo total knee replacement surgery with Verasense assisted balancing technology. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary total knee replacement
Key exclusion criteria (2 listed)
- Revision knee surgery
- Prior knee surgery
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: OrthosensorLigamentous balancing device | Device | Sensor Group |
Primary outcome
Average Score on the 12-Item Short Form Survey (SF-12) - Physical Component
Time frame: 3 months, 1 year, 2 years
SF-12 is a patient-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 is composed of a mental component score and a physical component score. The score range for each component is 0 to 100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Average Score on the 12-Item Short Form Survey (SF-12) - Mental Component
Time frame: 3 months, 1 year, 2 years
SF-12 is a patient-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 is composed of a mental component score and a physical component score. The score range for each component is 0 to 100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Average Score on the WOMAC Functional (F) Limitation Subscale
Time frame: 3 months, 1 year, 2 years
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a 24-item patient-report questionnaire used to assess pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC-F score is derived as the sum of the 17 item scores in the pain domain. It will be normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the Functional score and multiplying by 100.
Average Score on the WOMAC Stiffness (S) Subscale
Time frame: 3 months, 1 year, 2 years
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a 24-item patient-report questionnaire used to assess pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC-S score is derived as the sum of the 2 item scores in the pain domain. It will be normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the Functional score and multiplying by 100.
Average Score on the WOMAC Pain (P) Subscale
Time frame: 3 months, 1 year, 2 years
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a 24-item patient-report questionnaire used to assess pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC-P score is derived as the sum of the 5 item scores in the pain domain. It will be normalized and expressed on a 0-100 scale. This is done by dividing raw score by the highest possible value of the Pain score and multiplying by 100.
Knee Society Functional Score (KSFS)
Time frame: 3 months, 1 year, 2 years
The investigators will ask participants to answer survey questions about knee functionality on a scale of 0-100, 0 being the least functionality and 100 being the most functionality.
Average Arc of Range of Motion (Extension to Flexion)
Time frame: 3 months, 1 year, 2 years
A normal range of motion is 0º extension (completely straight leg) to 130º (a fully flexed leg).
2 secondary outcomes
Visual Analogue Scale Pain Level
Time frame: 1 week
Ambulation (Distance)
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Background: PubMed 28481384Chow JC, Breslauer L. The Use of Intraoperative Sensors Significantly Increases the Patient-Reported Rate of Improvement in Primary Total Knee Arthroplasty. Orthopedics. 2017 Jul 1;40(4):e648-e651. doi: 10.3928/01477447-20170503-01. Epub 2017 May 8.
- Background: PubMed 24768544Jacobs CA, Christensen CP, Karthikeyan T. Patient and intraoperative factors influencing satisfaction two to five years after primary total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1576-9. doi: 10.1016/j.arth.2014.03.022. Epub 2014 Mar 28.
- Background: PubMed 22532699Judge A, Arden NK, Cooper C, Kassim Javaid M, Carr AJ, Field RE, Dieppe PA. Predictors of outcomes of total knee replacement surgery. Rheumatology (Oxford). 2012 Oct;51(10):1804-13. doi: 10.1093/rheumatology/kes075. Epub 2012 Apr 24.
- Background: PubMed 21411706Kim KW, Han JW, Cho HJ, Chang CB, Park JH, Lee JJ, Lee SB, Seong SC, Kim TK. Association between comorbid depression and osteoarthritis symptom severity in patients with knee osteoarthritis. J Bone Joint Surg Am. 2011 Mar 16;93(6):556-63. doi: 10.2106/JBJS.I.01344.
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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.
Jeffrey Geller, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verasense in people with Osteoarthritis, Knee, run by Columbia University at 2 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 1 inclusion and 2 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 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 24 Sep 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?
Average Score on the 12-Item Short Form Survey (SF-12) - Physical Component (time frame: 3 months, 1 year, 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03628378, which also lists 15 linked publications.
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 24 Sep 2024.