Not provided
Not provided
Not provided
Not provided
Not provided
Expected enrollment and follow-up not met
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intra-operative with trial implants in place and after completing all surgical corrections. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Greg Golladay, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic Foundation | Weston | Florida | 33331 | United States | ||
| Emory University |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group A 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. TKA without "Verasense": TKA will be performed manually without the use of Verasense |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2015 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| TKA without "Verasense" | Procedure | TKA will be performed manually without the use of Verasense |
|
| 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). | 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. | 6 weeks, 6 months, 1 year, 2 years |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| Illinois Bone & Joint Institute | Morton Grove | Illinois | 60053 | United States |
| NYU Hospital for Joint Diseases | New York | New York | 10003 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | United States |
| Group B TKA With VERASENSE |
patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. 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 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline data was not collected for all participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A TKA Without VERASENSE | patients who undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. TKA without "Verasense": TKA will be performed manually without the use of Verasense |
| BG001 | Group B TKA With VERASENSE | patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. 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 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Incomplete baseline data collected for all participants in each sub-category (Group A: 4 missing / Group B: 11 missing). | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Incomplete baseline data collected for all participants in each sub-category (Group A: 0 missing / Group B: 2 missing). | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Incomplete baseline data collected for all participants in each sub-category (Group A: 36 missing / Group B: 20 missing). | Count of Participants | Participants |
| |||||||||||||||
| Body Mass Index (BMI) | Incomplete baseline data collected for all participants in each sub-category (Group A: 1 missing / Group B: 2 missing). | Mean | Standard Deviation | kg / m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data was not collected for all participants. Numbers analyzed represent evaluable cases. | Posted | Count of Participants | Participants | Intra-operative with trial implants in place and after completing all surgical corrections. |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Data was not collected for all participants. Numbers analyzed represent evaluable cases. | Posted | Mean | Standard Deviation | units on a scale | pre-operative, 6 weeks, 6 months, 1 year, 2 years |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Data was not collected for all participants. Numbers analyzed represent evaluable cases. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 6 weeks, 6 months, 1 year and 2 years |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Data was not collected for all participants. Numbers analyzed represent evaluable cases. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks, 6 months, 1 year, 2 years |
|
Date of inclusion to 2 years
The definition of adverse event and/or serious adverse event does not differ from ClinicalTrilas.gov definition.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A TKA Without VERASENSE | patients who undergo primary PCL-retaining or - sacrificing TKA without the use of VERASENSE to guide rotational alignment and balance. TKA without "Verasense": TKA will be performed manually without the use of Verasense | 0 | 170 | 8 | 170 | 0 | 170 |
| EG001 | Group B TKA With VERASENSE | patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance. 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 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. | 0 | 162 | 6 | 162 | 0 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment | Stiffness causing in mobilization under anesthesia |
|
| Chest pain unspecific | General disorders | MedDRA | Non-systematic Assessment |
| |
| Deep joint infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Shingles | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Kidney injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Hematoma | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
Not provided
The evaluation of tibiofemoral rotational alignment using intraoperative sensing which was highlighted in the study title, was identified off-label. Any data which should have been evaluated off-label are not included in the study results. Since the study has already ended at time point of data posting, the study title was not subsequently updated.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Barga | Stryker | 201 831 5073 | kevin.barga@stryker.com |
| Jun 13, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
|
|
| Asian |
|
|
| Hispanic or Latino |
|
|
| Other |
|
|
| White |
|
|
|
Patients who undergo primary PCL-retaining or - sacrificing TKA with the use of VERASENSE to guide rotational alignment and balance.
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 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.
|
|
|
|
|
|