TSolution One® Total Knee Arthroplasty

TSolution One® Total Knee Arthroplasty Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: TSolution One®

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital, The Heart Center®
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • North Carolina Specialty Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • St. Vincent Charity Medical Center
  • Texas
    • Houston, Texas, United States, 77094
      • Houston Methodist West Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. At least 21 years of age.
2. Skeletally mature, as evidenced by closed epiphyses.
3. Eligible for primary unilateral TKA due to osteoarthritis defined radiographically by a Kellgren-Lawrence Grade of 3 or higher.
4. Able to understand and willing to comply with the requirements of the study.
5. Able to give voluntary, written informed consent to participate and has signed an Informed Consent Form specific to this study.

Exclusion Criteria:

1. Has undergone previous open knee surgery in the operative knee.
2. Has a body mass index (BMI) > 40 kg/m2.
3. Is a candidate for bilateral TKA.
4. Has a coronal deformity greater than 20° or a sagittal flexion contracture greater than 15°.
5. 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.
6. 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.).
7. Has femoral or tibial bone stock that is of poor quality or inadequate to provide stability for femoral or tibial fixation.
8. Has any type of metallic implant in the operative leg.
9. 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)
10. Has a systemic illness or a neuromuscular, neurosensory, or musculoskeletal deficiency that would render the patient unable to perform appropriate postoperative rehabilitation.
11. Has a neuromuscular disorder that would create an unacceptable risk of prosthesis instability or fixation failure.
12. 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.).
13. Is pregnant or intends to become pregnant during the course of the study.
14. Has previously experienced a stroke.
15. 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.
16. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Think Surgical Inc.
• Collaborators: MCRA; Medical Metrics Diagnostics, Inc
• Investigators: Principal Investigator: Bernard N Stulberg, MD, St. Vincent Charity Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2017
• Primary Completion (Actual): June 26, 2019
• Study Completion (Actual): June 26, 2019

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Osteoarthritis; Arthroplasty; Knee; Robotic Surgery
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 16-PROTO-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes