An interventional study of TKA with "Verasense" and TKA without "Verasense" in Osteoarthritis, sponsored by Orthosensor, Inc.. Terminated at 6 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Orthosensor, Inc. · Not applicable, Interventional, and Basic science
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 500 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Orthosensor, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who undergo primary posterior cruciate ligament (PCL)-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance.
Procedure: TKA without "Verasense"
Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.
Device: 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.
TKA will be performed manually without the use of Verasense
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.
Time frame: Intra-operative with trial implants in place and after completing all surgical corrections.
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).
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).
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).
Time frame: 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.
Time frame: 6 weeks, 6 months, 1 year, 2 years
| Milestone | Group A TKA Without VERASENSE | Group B TKA With VERASENSE |
|---|---|---|
| Started | 170 | 162 |
| Completed | 46 | 9 |
| Not completed | 124 | 153 |
| Withdrew: Verasense type posterior stabilizing (ps) | 37 | 16 |
| Withdrew: No verasense type documented | 0 | 23 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Lost to follow-up (ltfu), patient withdrawal or physician decision but not specified | 86 | 112 |
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.
| Participants | Group A TKA Without VERASENSE | Group B TKA With VERASENSE |
|---|---|---|
| Participants with balanced knee | 65 | 103 |
| Participants with unbalanced knee | 68 | 20 |
"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).
| units on a scale | Group A TKA Without VERASENSE | Group B TKA With VERASENSE |
|---|---|---|
| Satisfaction Score pre-operative | 13.61 ± 6.94 | 13.35 ± 6.85 |
| Satisfaction Score 6 weeks | 26.20 ± 7.93 | 26.45 ± 8.28 |
| Satisfaction Score 6 months | 31.11 ± 8.71 | 31.30 ± 8.93 |
| Satisfaction Score 1 year | 32.44 ± 8.48 | 32.98 ± 8.22 |
| Satisfaction Score 2 years | 32.15 ± 7.90 | 33.21 ± 7.32 |
| Expectations Score pre-operative | 14.30 ± 1.40 | 14.19 ± 1.48 |
| Expectations 6 weeks | 9.62 ± 2.72 | 9.50 ± 2.74 |
| Expectations 6 months | 10.01 ± 2.82 | 9.92 ± 2.89 |
| Expectations 1 year | 10.28 ± 3.08 | 10.44 ± 3.04 |
| Expectations 2 years | 10.69 ± 3.35 | 10.81 ± 3.25 |
| Functional Score pre-operative | 36.75 ± 15.88 | 37.13 ± 16.11 |
| Functional Score 6 weeks 6 weeks | 44.84 ± 19.02 | 46.73 ± 18.91 |
| Functional Score 6 months | 69.25 ± 19.24 | 68.95 ± 19.03 |
| Functional Score 1 year | 71.82 ± 17.34 | 72.44 ± 17.09 |
| Functional Score 2 years | 68.69 ± 18.65 | 69.77 ± 18.29 |
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).
| units on a scale | Group A TKA Without VERASENSE | Group B TKA With VERASENSE |
|---|---|---|
| EQ-5D TTO pre-operative | 0.66 ± 0.18 | 0.63 ± 0.19 |
| EQ-5D TTO 6 weeks | 0.75 ± 0.18 | 0.78 ± 0.15 |
| EQ-5D TTO 6 months | 0.87 ± 0.14 | 0.85 ± 0.16 |
| EQ-5D TTO 1 year | 0.86 ± 0.18 | 0.87 ± 0.13 |
| EQ-5D TTO 2 years | 0.86 ± 0.14 | 0.73 ± 0.18 |
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.
| units on a scale | Group A TKA Without VERASENSE | Group B TKA With VERASENSE |
|---|---|---|
| FJS 6 weeks | 30.55 ± 25.52 | 33.31 ± 27.88 |
| FJS 6 months | 55.11 ± 26.89 | 55.46 ± 26.77 |
| FJS 1 year | 57.88 ± 28.23 | 60.34 ± 27.35 |
| FJS 2 years | 59.78 ± 32.22 | 65.73 ± 31.11 |
Collected over Date of inclusion to 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A TKA Without VERASENSE | 0/170 (0%) | 8/170 (4.7%) | 0/170 (0%) |
| Group B TKA With VERASENSE | 0/162 (0%) | 6/162 (3.7%) | 0/162 (0%) |
| Event | Group A TKA Without VERASENSE | Group B TKA With VERASENSE |
|---|---|---|
| StiffnessMusculoskeletal and connective tissue disorders | 4/170 | 3/162 |
| Deep joint infectionInfections and infestations | 0/170 | 2/162 |
| Kidney injuryInjury, poisoning and procedural complications | 0/170 | 1/162 |
| Chest pain unspecificGeneral disorders | 1/170 | 0/162 |
| ShinglesInfections and infestations | 1/170 | 0/162 |
| MelanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/170 | 0/162 |
| HematomaMusculoskeletal and connective tissue disorders | 1/170 | 0/162 |
Baseline data was not collected for all participants.
| Age, Continuous(years) | Group A TKA Without VERASENSE | Group B TKA With VERASENSE | Total |
|---|---|---|---|
| Mean | 67.29 ± 8.42 | 68.06 ± 8.12 | 67.73 ± 8.25 |
| Sex: Female, Male(Participants) | Group A TKA Without VERASENSE | Group B TKA With VERASENSE | Total |
|---|---|---|---|
| Female | 112 | 101 | 213 |
| Male | 58 | 59 | 117 |
| Race/Ethnicity, Customized(Participants) | Group A TKA Without VERASENSE | Group B TKA With VERASENSE | Total |
|---|---|---|---|
| African American or Black | 19 | 22 | 41 |
| Asian | 0 | 3 | 3 |
| Hispanic or Latino | 6 | 6 | 12 |
| Other | 4 | 2 | 6 |
| White | 105 | 109 | 214 |
| Body Mass Index (BMI)(kg / m^2) | Group A TKA Without VERASENSE | Group B TKA With VERASENSE | Total |
|---|---|---|---|
| Mean | 31.29 ± 6.65 | 31.11 ± 6.27 | 31.20 ± 6.46 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Orthosensor, Inc.