Osteoarthritis, KneeNCT03017261
TSolution One® Total Knee Arthroplasty
A study testing TSolution One® in people with Osteoarthritis, Knee, run by Think Surgical Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- TSolution One®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Feb 2017to 26 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Show all 16Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
St. Vincent Charity Medical Center
Cleveland, Ohio, 44115
North Carolina Specialty Hospital
Durham, North Carolina, 27704
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Houston Methodist West Hospital
Houston, Texas, 77094
NYU Langone Medical Center
New York, New York, 10016
St. Francis Hospital, The Heart Center®
Roslyn, New York, 11576
About this study
Official title: 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.
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
- Osteoarthritis, Knee
- Being tested
- TSolution One®
- Keywords
- Osteoarthritis, Arthroplasty, Robotic Surgery, Knee
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSolution One®Device
Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
| Study group | Role | What they receive |
|---|---|---|
| TSolution One® | Experimental | This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. Receives: Device: TSolution One® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 12 months follow-up
Secondary outcomes (30)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start18 Feb 2017
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Think Surgical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA, Medical Metrics Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Bernard N Stulberg, MD, Principal investigator, St. Vincent Charity Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017261
- Sponsor's protocol ID
- 16-PROTO-01
- Status last verified
- May 2020
- First submitted
- 19 Dec 2016
- Last updated
- 4 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TSolution One® Total Knee Arthroplasty Clinical Trial
- ClinicalTrials.gov ID
- NCT03017261
- Acronym / sponsor ID
- 16-PROTO-01
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Arthroplasty, Robotic Surgery, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Think Surgical Inc.Industry (pharma, biotech, devices)
- Collaborators
- MCRA, Medical Metrics Diagnostics, Inc
- Study start
- 18 Feb 2017 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Posted 22 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective, non-randomized, multicenter clinical trial is to determine whether robotic-assisted total knee arthroplasty performed with TSolution One® System is safe and effective for use as an alternative to the conventional manual techniques. Clinical and radiographic outcomes for robotic-assisted total knee arthroplasty performed with the TSolution One® System will be collected preoperatively, intraoperatively, and postoperatively up to a follow-up period of no less than 6 months and no more than 12 months. These outcomes will be compared to the ones reported in the literature for conventional manual techniques.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSolution One® | Experimental | Device: TSolution One®This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSolution One®Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts. | Device | TSolution One® |
Primary outcome
Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment
Time frame: 3 months follow-up
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.
Adverse Events
Time frame: Up to 12 months follow-up
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
30 secondary outcomes
Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events
Time frame: Up to 12 months follow-up
Bleeding Complications
Time frame: Up to 12 months follow-up
Change in (KSS) Knee Society Objective Score From Baseline
Time frame: Baseline to 6 Weeks
Change in Knee Society Objective Score From Baseline
Time frame: Baseline to 3 Months
Change in Knee Society Objective Score From Baseline
Time frame: Baseline to 6 Months
Change in Knee Society Objective Score From Baseline
Time frame: Baseline to 12 Months
Change in Knee Society Satisfaction Score From Baseline
Time frame: Baseline to 6 Weeks
Change in Knee Society Satisfaction Score From Baseline
Time frame: Baseline to 3 Months
Change in Knee Society Satisfaction Score From Baseline
Time frame: Baseline to 6 Months
Change in Knee Society Satisfaction Score From Baseline
Time frame: Baseline to 12 Months
Change in Knee Society Functional Score From Baseline
Time frame: Baseline to 6 Weeks
Change in Knee Society Functional Score From Baseline
Time frame: Baseline to 3 Months
Change in Knee Society Functional Score From Baseline
Time frame: Baseline to 6 Months
Change in Knee Society Functional Score From Baseline
Time frame: Baseline to 12 Months
Pre-operative (KSS) Knee Society Patient Expectation Score
Time frame: Baseline
Post-operative (KSS) Knee Society Patient Expectation Score
Time frame: 6 Weeks
Post-operative (KSS) Knee Society Patient Expectation Score
Time frame: 3 Months
Post-operative (KSS) Knee Society Patient Expectation Score
Time frame: 6 Months
Post-operative (KSS) Knee Society Patient Expectation Score
Time frame: 12 Months
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Time frame: Baseline to 6 Weeks
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Time frame: Baseline to 3 Months
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Time frame: Baseline to 6 Months
Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
Time frame: Baseline to 12 Months
Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline
Time frame: Baseline to 6 Weeks
Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
Time frame: Baseline to 3 Months
Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
Time frame: Baseline to 6 Months
Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
Time frame: Baseline to 12 Months
Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan
Time frame: Baseline to 3 Months
Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan
Time frame: Baseline to 3 Months
Tibial Slope Change From Pre-op Plan
Time frame: Baseline to 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard N Stulberg, MD principal investigator
St. Vincent Charity Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TSolution One® in people with Osteoarthritis, Knee, run by Think Surgical Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment (time frame: 3 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.