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TSolution One® Total Knee Arthroplasty

NCT03017261 · Think Surgical Inc. · Updated 4 June 2020

What is being tested
TSolution One®
For
Osteoarthritis, Knee
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 21 years and older. About 115 people. The full rules are on the registry page.
Where
United States (6 sites)
When
Starts or started 18 Feb 2017, ends 26 June 2019. Registered 11 Jan 2017.
Results
Posted on the registry on 22 May 2020.

In the researchers' words

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.
ClinicalTrials.gov, NCT03017261

Sites

  • Hackensack University Medical CenterHackensack, New Jersey, United States
  • NYU Langone Medical CenterNew York, New York, United States
  • St. Francis Hospital, The Heart Center®Roslyn, New York, United States
  • North Carolina Specialty HospitalDurham, North Carolina, United States
  • St. Vincent Charity Medical CenterCleveland, Ohio, United States
  • Houston Methodist West HospitalHouston, Texas, United States