CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 115 enrolled
Drug / intervention
TSolution One®device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03017261
NCT03017261N/ACompleted
CompareCT.gov

TSolution One® Total Knee Arthroplasty Clinical Trial

Think Surgical Inc.·interventional·Posted Jan 11, 2017·Updated Jun 4, 2020

In Brief

A clinical study evaluating TSolution One® for Osteoarthritis, Knee. Completed, enrolled 115 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesUnited States
CollaboratorsMCRA, Medical Metrics Diagnostics, Inc

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 11, 2017
Enrollment StartFeb 18, 2017
Primary CompletionJun 26, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.5 years ago

Interventions

TSolution One®device

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