TSolution One® Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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TSolution One® Total Knee Arthroplasty Clinical Trial

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: TSolution One®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 21 years of age. Skeletally mature, as evidenced by closed epiphyses. Eligible for primary unilateral TKA due to osteoarthritis defined radiographically by a Kellgren-Lawrence Grade of 3 or higher. Able to understand and willing to comply with the requirements of the study. Able to give voluntary, written informed consent to participate and has signed an Informed Consent Form specific to this study. Exclusion Criteria: Has undergone previous open knee surgery in the operative knee. Has a body mass index (BMI) > 40 kg/m2. Is a candidate for bilateral TKA. Has a coronal deformity greater than 20° or a sagittal flexion contracture greater than 15°. Has an active systemic infection or an active local infection in or near the operative knee joint, or has a previous history of joint infection. Has a pathological skeletal condition or skeletal immaturity which would significantly compromise the ability of the bone to withstand the stress required for preparation of the bones and proper implantation of the prostheses (e.g., severe osteoporosis, Paget's disease, renal osteodystrophy, AVN, sickle cell disease, etc.). Has femoral or tibial bone stock that is of poor quality or inadequate to provide stability for femoral or tibial fixation. Has any type of metallic implant in the operative leg. Has a known or suspected sensitivity to any of the materials in the investigational device or implant components (i.e. cobalt, chromium, titanium, stainless steel, titanium nitride, aluminum, polyethylene, PVC plastic) Has a systemic illness or a neuromuscular, neurosensory, or musculoskeletal deficiency that would render the patient unable to perform appropriate postoperative rehabilitation. Has a neuromuscular disorder that would create an unacceptable risk of prosthesis instability or fixation failure. Has significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.). Is pregnant or intends to become pregnant during the course of the study. Has previously experienced a stroke. Is participating concurrently in another clinical trial, or has participated in a clinical trial within the last 90 days, or intends to during the course of the study. Has a medical or psychiatric condition which, in the opinion of the investigator, poses a risk of the patient being unable to complete the study or presents risks associated with study participation.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TSolution One®<br>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. | Device: TSolution One®<br>* Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Arthroplasty, Robotic Surgery, Knee