Clinical trial NCT03017261: TSolution One® Total Knee Arthroplasty
Official title: TSolution One® Total Knee Arthroplasty Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Arthroplasty
Robotic Surgery
Knee
Lead sponsor: Think Surgical Inc.
Sponsor class: INDUSTRY
Collaborators: name: MCRA
name: Medical Metrics Diagnostics, Inc
First posted: 2017-01-11
Enrollment: 115
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Has undergone previous open knee surgery in the operative knee.
2. Has a body mass index (BMI) \> 40 kg/m2.
3. Is a candidate for bilateral TKA.
4. Has a coronal deformity greater than 20° or a sagittal flexion contracture greater than 15°.
5. Has an active systemic infection or an active local infection in or near the operative knee joint, or has a previous history of joint infection.
6. Has a pathological skeletal condition or skeletal immaturity which would significantly compromise the ability of the bone to withstand the stress required for preparation of the bones and proper implantation of the prostheses (e.g., severe osteoporosis, Paget's disease, renal osteodystrophy, AVN, sickle cell disease, etc.).
7. Has femoral or tibial bone stock that is of poor quality or inadequate to provide stability for femoral or tibial fixation.
8. Has any type of metallic implant in the operative leg.
9. Has a known or suspected sensitivity to any of the materials in the investigational device or implant components (i.e. cobalt, chromium, titanium, stainless steel, titanium nitride, aluminum, polyethylene, PVC plastic)
10. Has a systemic illness or a neuromuscular, neurosensory, or musculoskeletal deficiency that would render the patient unable to perform appropriate postoperative rehabilitation.
11. Has a neuromuscular disorder that would create an unacceptable risk of prosthesis instability or fixation failure.
12. Has significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. peripheral vascular disease, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.).
13. Is pregnant or intends to become pregnant during the course of the study.
14. Has previously experienced a stroke.
15. Is participating concurrently in another clinical trial, or has participated in a clinical trial within the last 90 days, or intends to during the course of the study.
16. Has a medical or psychiatric condition which, in the opinion of the investigator, poses a risk of the patient being unable to complete the study or presents risks associated with study participation.

Primary outcomes:
measure: Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment
timeFrame: 3 months follow-up
measure: Adverse Events
timeFrame: Up to 12 months follow-up
Secondary outcomes:
measure: Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events
timeFrame: Up to 12 months follow-up
measure: Bleeding Complications
timeFrame: Up to 12 months follow-up
measure: Change in (KSS) Knee Society Objective Score From Baseline
timeFrame: Baseline to 6 Weeks
measure: Change in Knee Society Objective Score From Baseline
timeFrame: Baseline to 3 Months
measure: Change in Knee Society Objective Score From Baseline
timeFrame: Baseline to 6 Months
measure: Change in Knee Society Objective Score From Baseline
timeFrame: Baseline to 12 Months
measure: Change in Knee Society Satisfaction Score From Baseline
timeFrame: Baseline to 6 Weeks
measure: Change in Knee Society Satisfaction Score From Baseline
timeFrame: Baseline to 3 Months
measure: Change in Knee Society Satisfaction Score From Baseline
timeFrame: Baseline to 6 Months
measure: Change in Knee Society Satisfaction Score From Baseline
timeFrame: Baseline to 12 Months
measure: Change in Knee Society Functional Score From Baseline
timeFrame: Baseline to 6 Weeks
measure: Change in Knee Society Functional Score From Baseline
timeFrame: Baseline to 3 Months
measure: Change in Knee Society Functional Score From Baseline
timeFrame: Baseline to 6 Months
measure: Change in Knee Society Functional Score From Baseline
timeFrame: Baseline to 12 Months
measure: Pre-operative (KSS) Knee Society Patient Expectation Score
timeFrame: Baseline
measure: Post-operative (KSS) Knee Society Patient Expectation Score
timeFrame: 6 Weeks
measure: Post-operative (KSS) Knee Society Patient Expectation Score
timeFrame: 3 Months
measure: Post-operative (KSS) Knee Society Patient Expectation Score
timeFrame: 6 Months
measure: Post-operative (KSS) Knee Society Patient Expectation Score
timeFrame: 12 Months
measure: Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
timeFrame: Baseline to 6 Weeks
measure: Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
timeFrame: Baseline to 3 Months
measure: Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
timeFrame: Baseline to 6 Months
measure: Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
timeFrame: Baseline to 12 Months
measure: Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline
timeFrame: Baseline to 6 Weeks
measure: Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
timeFrame: Baseline to 3 Months
measure: Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
timeFrame: Baseline to 6 Months
measure: Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
timeFrame: Baseline to 12 Months
measure: Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan
timeFrame: Baseline to 3 Months
measure: Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan
timeFrame: Baseline to 3 Months
measure: Tibial Slope Change From Pre-op Plan
timeFrame: Baseline to 3 Months
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital, The Heart Center®
state: New York
city: Durham
country: United States
facility: North Carolina Specialty Hospital
state: North Carolina
city: Cleveland
country: United States
facility: St. Vincent Charity Medical Center
state: Ohio
city: Houston
country: United States
facility: Houston Methodist West Hospital
state: Texas
Study officials:
affiliation: St. Vincent Charity Medical Center
name: Bernard N Stulberg, MD
role: PRINCIPAL_INVESTIGATOR
References: