TSolution One® Total Knee Arthroplasty

NCT03017261 | Completed Results FDA Device

• 1 other identifier: 16-PROTO-01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Osteoarthritis; Arthroplasty; Robotic Surgery; Knee

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment

  Comparison between planned and postoperative coronal limb alignment assessed as the difference between the planned hip-knee-ankle angle and the achieved hip-knee-ankle angle after surgery.

  3 months follow-up

• Adverse Events

  Adverse events will be assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events

  Up to 12 months follow-up

Secondary Outcomes (30)

• Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events

  Up to 12 months follow-up

• Bleeding Complications

  Up to 12 months follow-up

• Change in (KSS) Knee Society Objective Score From Baseline

  Baseline to 6 Weeks

• Change in Knee Society Objective Score From Baseline

  Baseline to 3 Months

• Change in Knee Society Objective Score From Baseline

  Baseline to 6 Months

Study Arms (1)

TSolution One®

EXPERIMENTAL

This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.

Device: TSolution One®

Interventions

TSolution One® DEVICE

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

TSolution One®

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Think Surgical Inc.: lead
• MCRA: collaborator
• Medical Metrics Diagnostics, Inc: collaborator

Study Sites (6)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

St. Francis Hospital, The Heart Center®

Roslyn, New York, 11576, United States

Location

North Carolina Specialty Hospital

Durham, North Carolina, 27704, United States

Location

St. Vincent Charity Medical Center

Cleveland, Ohio, 44115, United States

Location

Houston Methodist West Hospital

Houston, Texas, 77094, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Valentina Campanelli
• Organization: Think Surgical

vcampanelli@thinksurgical.com

510-249-2314

Study Officials

• Bernard N Stulberg, MD

  St. Vincent Charity Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 11, 2017
• Study Start: February 18, 2017
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: June 4, 2020
• Results First Posted: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)