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| Name | Class |
|---|---|
| MCRA | INDUSTRY |
| Medical Metrics Diagnostics, Inc | INDUSTRY |
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The goal of this prospective, non-randomized, multicenter clinical trial is to determine whether robotic-assisted total knee arthroplasty performed with TSolution One® System is safe and effective for use as an alternative to the conventional manual techniques. Clinical and radiographic outcomes for robotic-assisted total knee arthroplasty performed with the TSolution One® System will be collected preoperatively, intraoperatively, and postoperatively up to a follow-up period of no less than 6 months and no more than 12 months. These outcomes will be compared to the ones reported in the literature for conventional manual techniques.
This clinical investigation will be conducted as a prospective, non-randomized, multicenter study. The primary objective of this study is to demonstrate that the TSolution One System is safe and effective for use as an alternative to manual planning and sawing/cutting techniques. The primary effectiveness objective of this study is to demonstrate that the TSolution One® System is effective for use as an alternative to manual planning and sawing/cutting techniques by comparing the rate of malalignment for mechanical axis greater than 3° at 3 months to the rate reported in the literature (i.e. 32%) and to demonstrate significant clinical benefit by reducing the number of malaligned patients by at least 50% (i.e. from 32% to ≤ 16%). The safety objective of this study is based on the rate of intraoperative and postoperative TKA complications, with a follow-up period of no less than 6 months and no more than 12 months, and to compare this rate to the rate reported in the literature. The secondary objective of this study is to summarize the distribution of improvements in patients' self-reported assessment of postoperative function and quality-of-life from baseline to a maximum of 12 months. Additionally, other preoperative planning alignment goals (e.g. Knee V-V Alignment; Femoral Joint Line Alignment Angle; Tibial Joint Line Alignment Angle; Tibial Slope Angle) will be compared to the post-operative alignment at 3 months.
Investigators will recruit subjects from patients in their practice who require unilateral total knee arthroplasty. Patients will be screened to identify eligible candidates based on the inclusion and exclusion criteria. A total of one hundred fifteen (115) patients will be enrolled in the study across the participating sites. All patients will sign an informed consent form prior to participating in the study.
Prior to undergoing the investigational procedure, the patients will complete baseline surveys of function and quality of life (Knee Society Score survey and the SF-12 Health Survey) and have baseline radiographs and a CT scan of the knee.
Each patient will then undergo robotic-assisted total knee arthroplasty with the TSolution One® System. The investigators will evaluate intra- and postoperative complications. Postoperative radiographs and a CT scan will be used to measure limb alignment using a standardized radiographic evaluation protocol. Each patient will complete a postoperative Knee Society Score survey and the SF-12 Health Survey to assess functional outcomes and quality-of-life following the investigational procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TSolution One® | Experimental | This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TSolution One® | Device | Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment | Comparison between planned and postoperative coronal limb alignment assessed as the difference between the planned hip-knee-ankle angle and the achieved hip-knee-ankle angle after surgery. | 3 months follow-up |
| Adverse Events | Adverse events will be assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events | Up to 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events | Adverse events assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events. | Up to 12 months follow-up |
| Bleeding Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard N Stulberg, MD | St. Vincent Charity Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States | ||
| NYU Langone Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | TSolution One® | This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 Week Follow up |
| |||||||||||||
| 3 Month Follow up |
| |||||||||||||
| 6 Month Follow up |
| |||||||||||||
| 12 Month Follow up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TSolution One® | This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at surgery |
| 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 | Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment | Comparison between planned and postoperative coronal limb alignment assessed as the difference between the planned hip-knee-ankle angle and the achieved hip-knee-ankle angle after surgery. | 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort. | Posted | Number | 95% Confidence Interval | percentage of patients | 3 months follow-up |
|
6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use.
SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TSolution One® | This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stiffness of the joint | Musculoskeletal and connective tissue disorders | Systematic Assessment | Index Side |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal Fissure | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valentina Campanelli | Think Surgical | 510-249-2314 | vcampanelli@thinksurgical.com |
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| 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 | Sep 9, 2019 | Feb 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Number of patients experiencing bleeding complications will be assessed based on the incidence of transfusions required (autologous or allogenic). |
| Up to 12 months follow-up |
| Change in (KSS) Knee Society Objective Score From Baseline | The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point. | Baseline to 6 Weeks |
| Change in Knee Society Objective Score From Baseline | The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point. | Baseline to 3 Months |
| Change in Knee Society Objective Score From Baseline | The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point. | Baseline to 6 Months |
| Change in Knee Society Objective Score From Baseline | The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point. | Baseline to 12 Months |
| Change in Knee Society Satisfaction Score From Baseline | The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point. | Baseline to 6 Weeks |
| Change in Knee Society Satisfaction Score From Baseline | The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point. | Baseline to 3 Months |
| Change in Knee Society Satisfaction Score From Baseline | The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point. | Baseline to 6 Months |
| Change in Knee Society Satisfaction Score From Baseline | The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point. | Baseline to 12 Months |
| Change in Knee Society Functional Score From Baseline | The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point. | Baseline to 6 Weeks |
| Change in Knee Society Functional Score From Baseline | The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point. | Baseline to 3 Months |
| Change in Knee Society Functional Score From Baseline | The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point. | Baseline to 6 Months |
| Change in Knee Society Functional Score From Baseline | The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point. | Baseline to 12 Months |
| Pre-operative (KSS) Knee Society Patient Expectation Score | Patient reported expectations for anticipated improvement in pain level and increase in activities as a result of planned knee replacement surgery. Expectations are reported on a scale of 0-15 where higher numbers indicate higher patent expectations. A score of 0 indicates that a patient had no expectations. A score of 15 indicates the highest level of expectations. | Baseline |
| Post-operative (KSS) Knee Society Patient Expectation Score | Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded. | 6 Weeks |
| Post-operative (KSS) Knee Society Patient Expectation Score | Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded. | 3 Months |
| Post-operative (KSS) Knee Society Patient Expectation Score | Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded. | 6 Months |
| Post-operative (KSS) Knee Society Patient Expectation Score | Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded. | 12 Months |
| Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Baseline to 6 Weeks |
| Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Baseline to 3 Months |
| Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Baseline to 6 Months |
| Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Baseline to 12 Months |
| Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Baseline to 6 Weeks |
| Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Baseline to 3 Months |
| Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Baseline to 6 Months |
| Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Baseline to 12 Months |
| Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan | Comparison between planned and postoperative TJLA will be assessed as the difference between the planned TJLA angle and the achieved TJLA angle after surgery. | Baseline to 3 Months |
| Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan | Comparison between planned and postoperative FJLA will be assessed as the difference between the planned FJLA angle and the achieved FJLA angle after surgery. | Baseline to 3 Months |
| Tibial Slope Change From Pre-op Plan | Comparison between planned and postoperative Tibial Slope will be assessed as the difference between the planned Tibial Slope and the achieved Tibial Slope after surgery. | Baseline to 3 Months |
| New York |
| New York |
| 10016 |
| United States |
| St. Francis Hospital, The Heart Center® | Roslyn | New York | 11576 | United States |
| North Carolina Specialty Hospital | Durham | North Carolina | 27704 | United States |
| St. Vincent Charity Medical Center | Cleveland | Ohio | 44115 | United States |
| Houston Methodist West Hospital | Houston | Texas | 77094 | United States |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Adverse Events | Adverse events will be assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events | 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort. | Posted | Count of Participants | Participants | Up to 12 months follow-up |
|
|
|
| Secondary | Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events | Adverse events assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events. | 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort. | Posted | Count of Participants | Participants | Up to 12 months follow-up |
|
|
|
| Secondary | Bleeding Complications | Number of patients experiencing bleeding complications will be assessed based on the incidence of transfusions required (autologous or allogenic). | 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort. | Posted | Count of Participants | Participants | Up to 12 months follow-up |
|
|
|
| Secondary | Change in (KSS) Knee Society Objective Score From Baseline | The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 6 Weeks |
|
|
|
| Secondary | Change in Knee Society Objective Score From Baseline | The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 3 Months |
|
|
|
| Secondary | Change in Knee Society Objective Score From Baseline | The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 6 Months |
|
|
|
| Secondary | Change in Knee Society Objective Score From Baseline | The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 12 Months |
|
|
|
| Secondary | Change in Knee Society Satisfaction Score From Baseline | The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 6 Weeks |
|
|
|
| Secondary | Change in Knee Society Satisfaction Score From Baseline | The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 3 Months |
|
|
|
| Secondary | Change in Knee Society Satisfaction Score From Baseline | The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 6 Months |
|
|
|
| Secondary | Change in Knee Society Satisfaction Score From Baseline | The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 12 Months |
|
|
|
| Secondary | Change in Knee Society Functional Score From Baseline | The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 6 Weeks |
|
|
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| Secondary | Change in Knee Society Functional Score From Baseline | The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 3 Months |
|
|
|
| Secondary | Change in Knee Society Functional Score From Baseline | The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 6 Months |
|
|
|
| Secondary | Change in Knee Society Functional Score From Baseline | The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 12 Months |
|
|
|
| Secondary | Pre-operative (KSS) Knee Society Patient Expectation Score | Patient reported expectations for anticipated improvement in pain level and increase in activities as a result of planned knee replacement surgery. Expectations are reported on a scale of 0-15 where higher numbers indicate higher patent expectations. A score of 0 indicates that a patient had no expectations. A score of 15 indicates the highest level of expectations. | Posted | Mean | Standard Deviation | Units on a scale | Baseline |
|
|
|
| Secondary | Post-operative (KSS) Knee Society Patient Expectation Score | Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded. | Posted | Mean | Standard Deviation | Units on a scale | 6 Weeks |
|
|
|
| Secondary | Post-operative (KSS) Knee Society Patient Expectation Score | Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded. | Posted | Mean | Standard Deviation | Units on a scale | 3 Months |
|
|
|
| Secondary | Post-operative (KSS) Knee Society Patient Expectation Score | Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded. | Posted | Mean | Standard Deviation | Units on a scale | 6 Months |
|
|
|
| Secondary | Post-operative (KSS) Knee Society Patient Expectation Score | Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded. | Posted | Mean | Standard Deviation | Units on a scale | 12 Months |
|
|
|
| Secondary | Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 6 Weeks |
|
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| Secondary | Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 3 Months |
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| Secondary | Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 6 Months |
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| Secondary | Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | 8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 12 Months |
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| Secondary | Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 6 Weeks |
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| Secondary | Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 3 Months |
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| Secondary | Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 6 Months |
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| Secondary | Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline | The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 12 Months |
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| Secondary | Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan | Comparison between planned and postoperative TJLA will be assessed as the difference between the planned TJLA angle and the achieved TJLA angle after surgery. | Posted | Mean | Standard Deviation | Angle | Baseline to 3 Months |
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| Secondary | Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan | Comparison between planned and postoperative FJLA will be assessed as the difference between the planned FJLA angle and the achieved FJLA angle after surgery. | Posted | Mean | Standard Deviation | Angle | Baseline to 3 Months |
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| Secondary | Tibial Slope Change From Pre-op Plan | Comparison between planned and postoperative Tibial Slope will be assessed as the difference between the planned Tibial Slope and the achieved Tibial Slope after surgery. | Posted | Mean | Standard Deviation | Angle | Baseline to 3 Months |
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| 0 |
| 115 |
| 12 |
| 115 |
| 55 |
| 115 |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Non-index side |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Non-malignant asbestosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hip Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Due to injury |
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| Finger Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Due to injury |
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| Phimosis | Renal and urinary disorders | Systematic Assessment | With difficulty urinating |
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| Proctocolitis | Gastrointestinal disorders | Systematic Assessment | with diverticulitis |
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| Gastrointestinal Bleed | Gastrointestinal disorders | Systematic Assessment |
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| Dehydration | General disorders | Systematic Assessment |
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| Breast Cancer | Reproductive system and breast disorders | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | With neck pain |
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| Bladder Infection | Infections and infestations | Systematic Assessment |
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| Bleeding, unrelated to surgical site/procedure | Vascular disorders | Systematic Assessment | Nose bleed |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | With shortness of breath |
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| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment | Index Side |
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| Delayed Wound Healing | General disorders | Systematic Assessment |
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| Dental Infection | Infections and infestations | Systematic Assessment |
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| Dental Pain | General disorders | Systematic Assessment |
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| Difficulty Breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Edema | General disorders | Systematic Assessment | Index side |
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| Edema | General disorders | Systematic Assessment | Non-index side |
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| Edema | General disorders | Systematic Assessment | Lower Extremity |
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| Effusion | General disorders | Systematic Assessment | Index Side |
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| Exacerbation of anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment | Due to prescribed narcotics |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment | Due to injury |
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| Fatigue | General disorders | Systematic Assessment |
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| Generalized anxiety disorder | Psychiatric disorders | Systematic Assessment |
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| Hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Index knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Index knee pain | Injury, poisoning and procedural complications | Systematic Assessment | Due to injury |
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| Insect bite | General disorders | Systematic Assessment |
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| Nasal polyps | General disorders | Systematic Assessment |
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| MCL Injury | Injury, poisoning and procedural complications | Systematic Assessment | Due to injury |
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| Lichen Sclerosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Kidney Stone | Psychiatric disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Non-index knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Index side |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Non-index side |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Cervical |
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| Otitis media | Ear and labyrinth disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Surgical site |
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| Pressure sores | Skin and subcutaneous tissue disorders | Systematic Assessment | Surgical site |
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| Rheumatoid Arthritis | Immune system disorders | Systematic Assessment |
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| Retained device pins | Injury, poisoning and procedural complications | Systematic Assessment | Surgical site |
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| Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Upper |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Seroma | General disorders | Systematic Assessment | Index side |
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| Seroma | General disorders | Systematic Assessment | Surgical site |
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| Systemic Infection | Infections and infestations | Systematic Assessment |
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| Surgical Incision Infection | Infections and infestations | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Thigh pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Index side |
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| Temporary hearing loss | Ear and labyrinth disorders | Systematic Assessment |
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| Toe fungus | Infections and infestations | Systematic Assessment |
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| Umbilical hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Worsening of Parkinson's Disease | Nervous system disorders | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain (other musculoskeletal) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Gout |
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| Pain (other musculoskeletal) | Musculoskeletal and connective tissue disorders | Systematic Assessment | Bruise due to injury |
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PI must submit proposed publications to Sponsor for review per contract timelines.
Hospital & PI shall: