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TSolution One® Total Knee Arthroplasty

NCT03017261 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2020-06-04

Study results available
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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.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

TSolution One®

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

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Medical Metrics Diagnostics, Inc

    collaborator INDUSTRY

  • Think Surgical Inc.

    lead INDUSTRY

Principal Investigators

  • Bernard N Stulberg, MD · St. Vincent Charity Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-18
Primary Completion
2019-06-26
Completion
2019-06-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03017261 on ClinicalTrials.gov