TSolution One® Total Knee Arthroplasty

Completed · Not applicable

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT03017261

Run by

Think Surgical Inc.

People needed

115

Starts

2017-02-18

Expected to finish

2019-06-26

Last updated by the study team

2020-06-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Has undergone previous open knee surgery in the operative knee.
• Has a body mass index (BMI) > 40 kg/m2.
• Is a candidate for bilateral TKA.
• Has a coronal deformity greater than 20° or a sagittal flexion contracture greater than 15°.
• 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.
• 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.).
• Has femoral or tibial bone stock that is of poor quality or inadequate to provide stability for femoral or tibial fixation.
• Has any type of metallic implant in the operative leg.
• 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)
• Has a systemic illness or a neuromuscular, neurosensory, or musculoskeletal deficiency that would render the patient unable to perform appropriate postoperative rehabilitation.
• Has a neuromuscular disorder that would create an unacceptable risk of prosthesis instability or fixation failure.
• 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.).
• Is pregnant or intends to become pregnant during the course of the study.
• Has previously experienced a stroke.
• 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.
• 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.

Where it is running

• Hackensack University Medical Center — Hackensack, New Jersey, United States
• NYU Langone Medical Center — New York, New York, United States
• St. Francis Hospital, The Heart Center® — Roslyn, New York, United States
• North Carolina Specialty Hospital — Durham, North Carolina, United States
• St. Vincent Charity Medical Center — Cleveland, Ohio, United States
• Houston Methodist West Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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