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TSolution One® Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017261
Recruitment Status : Completed
First Posted : January 11, 2017
Results First Posted : May 22, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
Musculoskeletal Clinical Regulatory Advisers
Medical Metrics Diagnostics, Inc
Information provided by (Responsible Party):
Think Surgical Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis, Knee
Intervention Device: TSolution One®
Enrollment 115
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TSolution One®
Hide Arm/Group Description

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.

Period Title: 6 Week Follow up
Started 115
Completed [1] 115
Not Completed 0
[1]
8 did not complete the procedure with the device leaving 107 in the per protocol cohort.
Period Title: 3 Month Follow up
Started 115
Completed 115 [1]
Not Completed 0
[1]
1 failed to compete 3M imaging so only 114 have 3M data for tibial slope and KSS Objective Score.
Period Title: 6 Month Follow up
Started 115
Completed [1] 106
Not Completed 9
[1]
2 failed to compete 6M imaging so only 104 have 6M data for KSS Objective Score.
Period Title: 12 Month Follow up
Started 106
Completed 59 [1]
Not Completed 47
[1]
1 failed to compete 12M imaging so only 58 have 12M data for KSS Objective Score.
Arm/Group Title TSolution One®
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 115 participants
65.91  (8.28)
[1]
Measure Description: Age at surgery
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants
Female
57
  49.6%
Male
58
  50.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants
Hispanic or Latino
9
   7.8%
Not Hispanic or Latino
106
  92.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 115 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
   8.7%
White
96
  83.5%
More than one race
0
   0.0%
Unknown or Not Reported
7
   6.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 115 participants
115
1.Primary Outcome
Title Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment
Hide Description 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.
Time Frame 3 months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
11.2
(6.3 to 18.2)
2.Primary Outcome
Title Adverse Events
Hide Description 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
Time Frame Up to 12 months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events
Hide Description 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.
Time Frame Up to 12 months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Bleeding Complications
Hide Description Number of patients experiencing bleeding complications will be assessed based on the incidence of transfusions required (autologous or allogenic).
Time Frame Up to 12 months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Change in (KSS) Knee Society Objective Score From Baseline
Hide Description 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.
Time Frame Baseline to 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
39.1  (19.7)
6.Secondary Outcome
Title Change in Knee Society Objective Score From Baseline
Hide Description 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.
Time Frame Baseline to 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
44.1  (19.1)
7.Secondary Outcome
Title Change in Knee Society Objective Score From Baseline
Hide Description 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.
Time Frame Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 104
Mean (Standard Deviation)
Unit of Measure: Units on a scale
46.4  (18)
8.Secondary Outcome
Title Change in Knee Society Objective Score From Baseline
Hide Description 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.
Time Frame Baseline to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 58
Mean (Standard Deviation)
Unit of Measure: Units on a scale
48.2  (18)
9.Secondary Outcome
Title Change in Knee Society Satisfaction Score From Baseline
Hide Description 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.
Time Frame Baseline to 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
12.3  (10.3)
10.Secondary Outcome
Title Change in Knee Society Satisfaction Score From Baseline
Hide Description 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.
Time Frame Baseline to 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
16.2  (10.2)
11.Secondary Outcome
Title Change in Knee Society Satisfaction Score From Baseline
Hide Description 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.
Time Frame Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: Units on a scale
18.1  (9.2)
12.Secondary Outcome
Title Change in Knee Society Satisfaction Score From Baseline
Hide Description 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.
Time Frame Baseline to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
20.2  (9.5)
13.Secondary Outcome
Title Change in Knee Society Functional Score From Baseline
Hide Description 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.
Time Frame Baseline to 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
13.2  (20.3)
14.Secondary Outcome
Title Change in Knee Society Functional Score From Baseline
Hide Description 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.
Time Frame Baseline to 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
25.2  (21.3)
15.Secondary Outcome
Title Change in Knee Society Functional Score From Baseline
Hide Description 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.
Time Frame Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: Units on a scale
34.2  (19.6)
16.Secondary Outcome
Title Change in Knee Society Functional Score From Baseline
Hide Description 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.
Time Frame Baseline to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
42.3  (18.1)
17.Secondary Outcome
Title Pre-operative (KSS) Knee Society Patient Expectation Score
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
14.5  (1)
18.Secondary Outcome
Title Post-operative (KSS) Knee Society Patient Expectation Score
Hide Description 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.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
9.8  (3.2)
19.Secondary Outcome
Title Post-operative (KSS) Knee Society Patient Expectation Score
Hide Description 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.
Time Frame 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
10.1  (3.0)
20.Secondary Outcome
Title Post-operative (KSS) Knee Society Patient Expectation Score
Hide Description 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.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: Units on a scale
10.3  (3.1)
21.Secondary Outcome
Title Post-operative (KSS) Knee Society Patient Expectation Score
Hide Description 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.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
11.3  (2.7)
22.Secondary Outcome
Title Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Hide Description 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.
Time Frame Baseline to 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.6  (11.2)
23.Secondary Outcome
Title Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Hide Description 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.
Time Frame Baseline to 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
10.6  (10.4)
24.Secondary Outcome
Title Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Hide Description 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.
Time Frame Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: Units on a scale
13.3  (11.4)
25.Secondary Outcome
Title Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Hide Description 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.
Time Frame Baseline to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
15.9  (10.5)
26.Secondary Outcome
Title Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline
Hide Description 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.
Time Frame Baseline to 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.0  (10.9)
27.Secondary Outcome
Title Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
Hide Description 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.
Time Frame Baseline to 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.4  (10.5)
28.Secondary Outcome
Title Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
Hide Description 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.
Time Frame Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.4  (9.6)
29.Secondary Outcome
Title Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
Hide Description 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.
Time Frame Baseline to 12 Months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.9  (11.0)
30.Secondary Outcome
Title Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan
Hide Description Comparison between planned and postoperative TJLA will be assessed as the difference between the planned TJLA angle and the achieved TJLA angle after surgery.
Time Frame Baseline to 3 Months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Angle
.35  (1.64)
31.Secondary Outcome
Title Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan
Hide Description Comparison between planned and postoperative FJLA will be assessed as the difference between the planned FJLA angle and the achieved FJLA angle after surgery.
Time Frame Baseline to 3 Months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: Angle
-0.93  (1.29)
32.Secondary Outcome
Title Tibial Slope Change From Pre-op Plan
Hide Description 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.
Time Frame Baseline to 3 Months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title TSolution One®
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: Angle
-0.01  (1.53)
Time Frame 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.
Adverse Event Reporting Description

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

 
Arm/Group Title TSolution One®
Hide Arm/Group Description

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.

All-Cause Mortality
TSolution One®
Affected / at Risk (%)
Total   0/115 (0.00%)    
Hide Serious Adverse Events
TSolution One®
Affected / at Risk (%) # Events
Total   12/115 (10.43%)    
Cardiac disorders   
Congestive Heart Failure   1/115 (0.87%)  1
Gastrointestinal disorders   
Proctocolitis  [1]  1/115 (0.87%)  1
Gastrointestinal Bleed   1/115 (0.87%)  1
General disorders   
Dehydration   1/115 (0.87%)  1
Musculoskeletal and connective tissue disorders   
Stiffness of the joint  [2]  3/115 (2.61%)  3
Osteoarthritis  [3]  1/115 (0.87%)  1
Hip Fracture  [4]  1/115 (0.87%)  1
Finger Fracture  [4]  1/115 (0.87%)  1
Renal and urinary disorders   
Phimosis  [5]  1/115 (0.87%)  1
Reproductive system and breast disorders   
Breast Cancer   1/115 (0.87%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia   2/115 (1.74%)  2
Non-malignant asbestosis   1/115 (0.87%)  1
Indicates events were collected by systematic assessment
[1]
with diverticulitis
[2]
Index Side
[3]
Non-index side
[4]
Due to injury
[5]
With difficulty urinating
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TSolution One®
Affected / at Risk (%) # Events
Total   55/115 (47.83%)    
Blood and lymphatic system disorders   
Exacerbation of anemia   1/115 (0.87%)  1
Cardiac disorders   
Arrhythmia   2/115 (1.74%)  2
Ear and labyrinth disorders   
Otitis media   1/115 (0.87%)  1
Temporary hearing loss   1/115 (0.87%)  1
Gastrointestinal disorders   
Nausea   1/115 (0.87%)  1
General disorders   
Delayed Wound Healing   2/115 (1.74%)  2
Dental Pain   1/115 (0.87%)  1
Edema  [1]  5/115 (4.35%)  5
Edema  [2]  1/115 (0.87%)  1
Edema  [3]  1/115 (0.87%)  1
Effusion  [1]  4/115 (3.48%)  5
Fatigue   2/115 (1.74%)  2
Insect bite   1/115 (0.87%)  1
Nasal polyps   1/115 (0.87%)  1
Seroma  [1]  1/115 (0.87%)  1
Seroma  [4]  1/115 (0.87%)  1
Immune system disorders   
Rheumatoid Arthritis   1/115 (0.87%)  1
Infections and infestations   
Bladder Infection   1/115 (0.87%)  1
Dental Infection   1/115 (0.87%)  1
Systemic Infection   2/115 (1.74%)  2
Surgical Incision Infection   2/115 (1.74%)  2
Toe fungus   1/115 (0.87%)  1
Injury, poisoning and procedural complications   
Fall  [5]  1/115 (0.87%)  2
Fall  [6]  4/115 (3.48%)  4
Index knee pain  [6]  1/115 (0.87%)  1
MCL Injury  [6]  1/115 (0.87%)  1
Retained device pins  [4]  1/115 (0.87%)  1
Musculoskeletal and connective tissue disorders   
Back Pain   3/115 (2.61%)  3
Back Pain  [7]  1/115 (0.87%)  1
Hernia   1/115 (0.87%)  1
Hip pain   1/115 (0.87%)  1
Index knee pain   3/115 (2.61%)  3
Non-index knee pain   3/115 (2.61%)  3
Osteoarthritis  [1]  1/115 (0.87%)  1
Osteoarthritis  [2]  4/115 (3.48%)  4
Osteoarthritis  [8]  1/115 (0.87%)  1
Thigh pain  [1]  1/115 (0.87%)  1
Umbilical hernia   1/115 (0.87%)  1
Pain (other musculoskeletal)  [9]  1/115 (0.87%)  1
Pain (other musculoskeletal)  [10]  1/115 (0.87%)  1
Nervous system disorders   
Worsening of Parkinson's Disease   1/115 (0.87%)  1
Psychiatric disorders   
Generalized anxiety disorder   1/115 (0.87%)  1
Kidney Stone   1/115 (0.87%)  1
Renal and urinary disorders   
Urinary retention   2/115 (1.74%)  2
Urinary tract infection   1/115 (0.87%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchitis   1/115 (0.87%)  1
Cough  [11]  1/115 (0.87%)  1
Difficulty Breathing   1/115 (0.87%)  2
Respiratory Tract Infection  [12]  2/115 (1.74%)  2
Pneumonia   1/115 (0.87%)  1
Sore throat   1/115 (0.87%)  1
Skin and subcutaneous tissue disorders   
Anal Fissure   1/115 (0.87%)  1
Lichen Sclerosis   1/115 (0.87%)  1
Rash  [4]  2/115 (1.74%)  2
Pressure sores  [4]  1/115 (0.87%)  1
Urticaria   1/115 (0.87%)  1
Vascular disorders   
Bleeding, unrelated to surgical site/procedure  [13]  1/115 (0.87%)  1
Deep Vein Thrombosis  [1]  1/115 (0.87%)  1
Indicates events were collected by systematic assessment
[1]
Index side
[2]
Non-index side
[3]
Lower Extremity
[4]
Surgical site
[5]
Due to prescribed narcotics
[6]
Due to injury
[7]
With neck pain
[8]
Cervical
[9]
Gout
[10]
Bruise due to injury
[11]
With shortness of breath
[12]
Upper
[13]
Nose bleed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

PI must submit proposed publications to Sponsor for review per contract timelines.

Hospital & PI shall:

  • not publish the Hospital's and PI's results until a multi-center publication is released; however, if a multi-center publication is not released within 1 year after the study, Hospital & PI may publish the results of their activities.
  • keep all unpublished data & results confidential and not disclose such in greater detail than disclosed in any publications, presentations or disclosures.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Valentina Campanelli
Organization: Think Surgical
Phone: 510-249-2314
EMail: vcampanelli@thinksurgical.com
Layout table for additonal information
Responsible Party: Think Surgical Inc.
ClinicalTrials.gov Identifier: NCT03017261    
Other Study ID Numbers: 16-PROTO-01
First Submitted: December 19, 2016
First Posted: January 11, 2017
Results First Submitted: April 14, 2020
Results First Posted: May 22, 2020
Last Update Posted: June 4, 2020