CompletedNCT03017261Updated Jun 4, 2020Results posted

TSolution One® Total Knee Arthroplasty

An interventional study of TSolution One® in Osteoarthritis, Knee, sponsored by Think Surgical Inc.. Completed at 6 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by Think Surgical Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 115
Allocation: Not applicable
Ages: 21 Years and older
Sex: All

Study summary

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.

Read the 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.

Conditions studied

Osteoarthritis, Knee

Browse trials for

Keywords

Osteoarthritis
Arthroplasty
Robotic Surgery
Knee

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 115 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

This is the only study on the registry with Think Surgical Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 115 participants (actual)

Study arms

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®

Interventions

DeviceTSolution One®
Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.

What researchers measure

Primary outcomes

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.
Time frame: 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
Time frame: Up to 12 months follow-up

Secondary outcomes

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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 3 Months

Results

Posted May 22, 2020

Participant flow

6 Week Follow up

Participant flow — 6 Week Follow up
Milestone	TSolution One®
Started	115
Completed	115
Not completed	0

3 Month Follow up

Participant flow — 3 Month Follow up
Milestone	TSolution One®
Started	115
Completed	115
Not completed	0

6 Month Follow up

Participant flow — 6 Month Follow up
Milestone	TSolution One®
Started	115
Completed	106
Not completed	9

12 Month Follow up

Participant flow — 12 Month Follow up
Milestone	TSolution One®
Started	106
Completed	59
Not completed	47

Outcome measures

PrimaryPercentage 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.

Time frame:: 3 months follow-up
Reported as:: Number · percentage of patients

Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment
percentage of patients	TSolution One®
Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment	11.2 (6.3 to 18.2)

PrimaryAdverse 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

Time frame:: Up to 12 months follow-up
Reported as:: Count of participants · Participants

Adverse Events
Participants	TSolution One®
Adverse Events	0

SecondaryPercentage 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.

Time frame:: Up to 12 months follow-up
Reported as:: Count of participants · Participants

Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events
Participants	TSolution One®
Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events	0

SecondaryBleeding Complications

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
Reported as:: Count of participants · Participants

Bleeding Complications
Participants	TSolution One®
Bleeding Complications	0

SecondaryChange 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.

Time frame:: Baseline to 6 Weeks
Reported as:: Mean · Units on a scale

Change in (KSS) Knee Society Objective Score From Baseline
Units on a scale	TSolution One®
Change in (KSS) Knee Society Objective Score From Baseline	39.1 ± 19.7

SecondaryChange in Knee Society Objective Score From Baseline

Time frame:: Baseline to 3 Months
Reported as:: Mean · Units on a scale

Change in Knee Society Objective Score From Baseline
Units on a scale	TSolution One®
Change in Knee Society Objective Score From Baseline	44.1 ± 19.1

SecondaryChange in Knee Society Objective Score From Baseline

Time frame:: Baseline to 6 Months
Reported as:: Mean · Units on a scale

Change in Knee Society Objective Score From Baseline
Units on a scale	TSolution One®
Change in Knee Society Objective Score From Baseline	46.4 ± 18

SecondaryChange in Knee Society Objective Score From Baseline

Time frame:: Baseline to 12 Months
Reported as:: Mean · Units on a scale

Change in Knee Society Objective Score From Baseline
Units on a scale	TSolution One®
Change in Knee Society Objective Score From Baseline	48.2 ± 18

SecondaryChange 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.

Time frame:: Baseline to 6 Weeks
Reported as:: Mean · Units on a scale

Change in Knee Society Satisfaction Score From Baseline
Units on a scale	TSolution One®
Change in Knee Society Satisfaction Score From Baseline	12.3 ± 10.3

SecondaryChange in Knee Society Satisfaction Score From Baseline

Time frame:: Baseline to 3 Months
Reported as:: Mean · Units on a scale

Change in Knee Society Satisfaction Score From Baseline
Units on a scale	TSolution One®
Change in Knee Society Satisfaction Score From Baseline	16.2 ± 10.2

SecondaryChange in Knee Society Satisfaction Score From Baseline

Time frame:: Baseline to 6 Months
Reported as:: Mean · Units on a scale

Change in Knee Society Satisfaction Score From Baseline
Units on a scale	TSolution One®
Change in Knee Society Satisfaction Score From Baseline	18.1 ± 9.2

SecondaryChange in Knee Society Satisfaction Score From Baseline

Time frame:: Baseline to 12 Months
Reported as:: Mean · Units on a scale

Change in Knee Society Satisfaction Score From Baseline
Units on a scale	TSolution One®
Change in Knee Society Satisfaction Score From Baseline	20.2 ± 9.5

SecondaryChange 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.

Time frame:: Baseline to 6 Weeks
Reported as:: Mean · Units on a scale

Change in Knee Society Functional Score From Baseline
Units on a scale	TSolution One®
Change in Knee Society Functional Score From Baseline	13.2 ± 20.3

SecondaryChange in Knee Society Functional Score From Baseline

Time frame:: Baseline to 3 Months
Reported as:: Mean · Units on a scale

Change in Knee Society Functional Score From Baseline
Units on a scale	TSolution One®
Change in Knee Society Functional Score From Baseline	25.2 ± 21.3

SecondaryChange in Knee Society Functional Score From Baseline

Time frame:: Baseline to 6 Months
Reported as:: Mean · Units on a scale

Change in Knee Society Functional Score From Baseline
Units on a scale	TSolution One®
Change in Knee Society Functional Score From Baseline	34.2 ± 19.6

SecondaryChange in Knee Society Functional Score From Baseline

Time frame:: Baseline to 12 Months
Reported as:: Mean · Units on a scale

Change in Knee Society Functional Score From Baseline
Units on a scale	TSolution One®
Change in Knee Society Functional Score From Baseline	42.3 ± 18.1

SecondaryPre-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.

Time frame:: Baseline
Reported as:: Mean · Units on a scale

Pre-operative (KSS) Knee Society Patient Expectation Score
Units on a scale	TSolution One®
Pre-operative (KSS) Knee Society Patient Expectation Score	14.5 ± 1

SecondaryPost-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.

Time frame:: 6 Weeks
Reported as:: Mean · Units on a scale

Post-operative (KSS) Knee Society Patient Expectation Score
Units on a scale	TSolution One®
Post-operative (KSS) Knee Society Patient Expectation Score	9.8 ± 3.2

SecondaryPost-operative (KSS) Knee Society Patient Expectation Score

Time frame:: 3 Months
Reported as:: Mean · Units on a scale

Post-operative (KSS) Knee Society Patient Expectation Score
Units on a scale	TSolution One®
Post-operative (KSS) Knee Society Patient Expectation Score	10.1 ± 3.0

SecondaryPost-operative (KSS) Knee Society Patient Expectation Score

Time frame:: 6 Months
Reported as:: Mean · Units on a scale

Post-operative (KSS) Knee Society Patient Expectation Score
Units on a scale	TSolution One®
Post-operative (KSS) Knee Society Patient Expectation Score	10.3 ± 3.1

SecondaryPost-operative (KSS) Knee Society Patient Expectation Score

Time frame:: 12 Months
Reported as:: Mean · Units on a scale

Post-operative (KSS) Knee Society Patient Expectation Score
Units on a scale	TSolution One®
Post-operative (KSS) Knee Society Patient Expectation Score	11.3 ± 2.7

SecondaryChange 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.

Time frame:: Baseline to 6 Weeks
Reported as:: Mean · Units on a scale

Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Units on a scale	TSolution One®
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline	4.6 ± 11.2

SecondaryChange in SF-12 (Short-form 12 Question) Physical Component Score From Baseline

Time frame:: Baseline to 3 Months
Reported as:: Mean · Units on a scale

Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Units on a scale	TSolution One®
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline	10.6 ± 10.4

SecondaryChange in SF-12 (Short-form 12 Question) Physical Component Score From Baseline

Time frame:: Baseline to 6 Months
Reported as:: Mean · Units on a scale

Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Units on a scale	TSolution One®
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline	13.3 ± 11.4

SecondaryChange in SF-12 (Short-form 12 Question) Physical Component Score From Baseline

Time frame:: Baseline to 12 Months
Reported as:: Mean · Units on a scale

Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Units on a scale	TSolution One®
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline	15.9 ± 10.5

SecondaryChange 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.

Time frame:: Baseline to 6 Weeks
Reported as:: Mean · Units on a scale

Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline
Units on a scale	TSolution One®
Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline	-2.0 ± 10.9

SecondaryChange 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.

Time frame:: Baseline to 3 Months
Reported as:: Mean · Units on a scale

Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
Units on a scale	TSolution One®
Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline	0.4 ± 10.5

SecondaryChange 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.

Time frame:: Baseline to 6 Months
Reported as:: Mean · Units on a scale

Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
Units on a scale	TSolution One®
Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline	1.4 ± 9.6

SecondaryChange 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.

Time frame:: Baseline to 12 Months
Reported as:: Mean · Units on a scale

Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
Units on a scale	TSolution One®
Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline	2.9 ± 11.0

SecondaryTibial 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.

Time frame:: Baseline to 3 Months
Reported as:: Mean · Angle

Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan
Angle	TSolution One®
Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan	.35 ± 1.64

SecondaryFemoral 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.

Time frame:: Baseline to 3 Months
Reported as:: Mean · Angle

Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan
Angle	TSolution One®
Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan	-0.93 ± 1.29

SecondaryTibial 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.

Time frame:: Baseline to 3 Months
Reported as:: Mean · Angle

Tibial Slope Change From Pre-op Plan
Angle	TSolution One®
Tibial Slope Change From Pre-op Plan	-0.01 ± 1.53

Adverse events

Collected over 6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
TSolution One®	0/115 (0%)	12/115 (10.4%)	55/115 (47.8%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	TSolution One®
Stiffness of the jointMusculoskeletal and connective tissue disorders	3/115
PneumoniaRespiratory, thoracic and mediastinal disorders	2/115
OsteoarthritisMusculoskeletal and connective tissue disorders	1/115
Congestive Heart FailureCardiac disorders	1/115
Non-malignant asbestosisRespiratory, thoracic and mediastinal disorders	1/115
Hip FractureMusculoskeletal and connective tissue disorders	1/115
Finger FractureMusculoskeletal and connective tissue disorders	1/115
PhimosisRenal and urinary disorders	1/115
ProctocolitisGastrointestinal disorders	1/115
Gastrointestinal BleedGastrointestinal disorders	1/115

Most frequent other events

Showing 10 of 58

Most frequent other events
Event	TSolution One®
EdemaGeneral disorders	5/115
EffusionGeneral disorders	4/115
FallInjury, poisoning and procedural complications	4/115
OsteoarthritisMusculoskeletal and connective tissue disorders	4/115
Back PainMusculoskeletal and connective tissue disorders	3/115
Index knee painMusculoskeletal and connective tissue disorders	3/115
Non-index knee painMusculoskeletal and connective tissue disorders	3/115
ArrhythmiaCardiac disorders	2/115
Delayed Wound HealingGeneral disorders	2/115
FatigueGeneral disorders	2/115

Baseline characteristics

Age, Continuous
Age, Continuous(years)	TSolution One®
Mean	65.91 ± 8.28

Sex: Female, Male
Sex: Female, Male(Participants)	TSolution One®
Female	57
Male	58

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	TSolution One®
Hispanic or Latino	9
Not Hispanic or Latino	106
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	TSolution One®
American Indian or Alaska Native	0
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	10
White	96
More than one race	0
Unknown or Not Reported	7

Region of Enrollment
Region of Enrollment(participants)	TSolution One®
United States	115

Study locations

6 sites

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

References and documents

Study documents

Protocol and statistical analysis plan · Sep 9, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03017261
Lead sponsor: Think Surgical Inc.
Collaborators: MCRA, Medical Metrics Diagnostics, Inc
Responsible party: Sponsor
First posted: Jan 11, 2017
Start date: Feb 18, 2017
Primary completion: Jun 26, 2019
Completion: Jun 26, 2019
Results posted: May 22, 2020
Last update: Jun 4, 2020

Study contacts

Bernard N Stulberg, MD

principal investigator · St. Vincent Charity Medical Center

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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TSolution One® Total Knee Arthroplasty

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