TSolution One® Total Knee Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03017261|
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Device: TSolution One®||Not Applicable|
This clinical investigation will be conducted as a prospective, non‐randomized, multicenter study. The primary objective of this study is to demonstrate that the TSolution One System is safe and effective for use as an alternative to manual planning and sawing/cutting techniques. The primary effectiveness objective of this study is to demonstrate that the TSolution One® System is effective for use as an alternative to manual planning and sawing/cutting techniques by comparing the rate of malalignment for mechanical axis greater than 3° at 3 months to the rate reported in the literature (i.e. 32%) and to demonstrate significant clinical benefit by reducing the number of malaligned patients by at least 50% (i.e. from 32% to ≤ 16%). The safety objective of this study is based on the rate of intraoperative and postoperative TKA complications, with a follow-up period of no less than 6 months and no more than 12 months, and to compare this rate to the rate reported in the literature. The secondary objective of this study is to summarize the distribution of improvements in patients' self-reported assessment of postoperative function and quality-of-life from baseline to a maximum of 12 months. Additionally, other preoperative planning alignment goals (e.g. Knee V‐V Alignment; Femoral Joint Line Alignment Angle; Tibial Joint Line Alignment Angle; Tibial Slope Angle) will be compared to the post‐operative alignment at 3 months.
Investigators will recruit subjects from patients in their practice who require unilateral total knee arthroplasty. Patients will be screened to identify eligible candidates based on the inclusion and exclusion criteria. A total of one hundred fifteen (115) patients will be enrolled in the study across the participating sites. All patients will sign an informed consent form prior to participating in the study.
Prior to undergoing the investigational procedure, the patients will complete baseline surveys of function and quality of life (Knee Society Score survey and the SF‐12 Health Survey) and have baseline radiographs and a CT scan of the knee.
Each patient will then undergo robotic‐assisted total knee arthroplasty with the TSolution One® System. The investigators will evaluate intra‐ and postoperative complications. Postoperative radiographs and a CT scan will be used to measure limb alignment using a standardized radiographic evaluation protocol. Each patient will complete a postoperative Knee Society Score survey and the SF‐12 Health Survey to assess functional outcomes and quality‐of‐life following the investigational procedure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TSolution One® Total Knee Arthroplasty Clinical Trial|
|Actual Study Start Date :||February 8, 2017|
|Actual Primary Completion Date :||June 26, 2019|
|Actual Study Completion Date :||June 26, 2019|
Experimental: TSolution One®
This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
Device: TSolution One®
Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
- Comparison between Planned and Postoperative Coronal Limb Alignment [ Time Frame: 3 months follow-up ]Comparison between planned and postoperative coronal limb alignment will be 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‐assisted implantation experiencing the composite safety endpoint of typical adverse events
- Bleeding Complications [ Time Frame: Up to 12 months follow-up ]Bleeding complications will be assessed based on the incidence of transfusions required (autologous or allogenic).
- Knee Society Score [ Time Frame: Baseline and up to 12 months follow-up ]Difference in scores before and after the surgery will be computed.
- SF-12 score [ Time Frame: Baseline and up to 12 months follow-up ]Difference in scores before and after the surgery will be computed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017261
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|NYU Langone Medical Center|
|New York, New York, United States, 10016|
|St. Francis Hospital|
|New York, New York, United States, 11576|
|United States, North Carolina|
|North Carolina Specialty Hospital|
|Durham, North Carolina, United States, 27704|
|United States, Ohio|
|St. Vincent Charity Medical Center|
|Cleveland, Ohio, United States, 44115|
|United States, Texas|
|Houston Methodist West Hospital|
|Houston, Texas, United States, 77094|
|Principal Investigator:||Bernard N Stulberg, MD||St. Vincent Charity Medical Center|