Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty

A Prospective Multi-Center Study of the Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty

The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.

Study Overview

• Status: Withdrawn
• Conditions: Shoulder Osteoarthritis

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Hausham, Germany, 83734
    • Krankenhaus Agatharied

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult subject with clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis.

Description

Inclusion Criteria:

• A subject must meet all of the following inclusion criteria in order to enter the study:

  • Adult subject 18 years or older,
  • Clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis,
  • Scapula and proximal humerus must have reached skeletal maturity,
  • Willing and able to comply with the protocol,
  • Willing and able to personally sign the informed consent form,
  • Subject is legally competent, understands the nature, significance and implications of the clinical investigation, and is able to form a rational intention in the light of these facts.

Exclusion Criteria:

• A subject will not be eligible to participate in the study if any of the following conditions is present:

  • lack of sufficient sound bone to seat and support the implant, including that resulting from skeletal immaturity, osteoporosis or erosive arthritis,
  • Severe Walch grade B2 glenoid defined as >60% posterior head displacement and >20% posterior glenoid bone loss,
  • metal allergies or sensitivity,
  • infection at or near the site of implantation,
  • distant or systemic infection.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Device: Simpliciti™ System; The Simpliciti™ nucleus is a humeral prosthesis intended for total and hemi shoulder arthroplasty in patients with a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The implant is sized to match and replicate the anatomy of the proximal humerus, while maintaining a bone conserving approach. It does not extend beyond the metaphysis, leaving the humeral canal untouched. Fixation is enhanced through a porous coating with a high coefficient of friction; resulting in a solid initial fit and long term fixation. The Simpliciti™ nucleus is designed to receive a humeral head. The Simpliciti™ system is authorized to bear the CE mark and will be investigated within this clinical study in accordance with its intended use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with device related adverse events as a measure of safety	All adverse events will be summarized by the number and percentage of patients with each type of event. The following will be summarized separately: procedure related adverse events, device related adverse events, anticipated adverse events. Additionally, the incidence of serious device associated adverse events will be summarized.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Range of Motions (ROM) as a measure of effectiveness	Changes in ROM variables from the pre-implant visit to each follow-up visit will be calculated and sumarized until 24-month visit.	24 months
Change in the Constant Score as a measure of effectiveness	Changes in the Constant Score from the pre-implant visit to each follow-up visits will be calculated and summarized until 24-month visit.	24 months
Change in the DASH Score as a measure of improvement in the patients' Quality of Life	Changes in the DASH Score from the pre-implant visit to each follow-up visits will be calculated and summarised until 24-month visit.	24 months
Change in humeral cortical thickness as an evaluation of Stress Shielding	Changes in humeral cortical thickness from the pre-implant to 24-month visit will be mesured according to the modified method of Tingart & Al.	24 months

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH
• Investigators: Study Director: Steve A. Erickson, Stryker Trauma GmbH; Principal Investigator: Ulrich Brunner, MD, Prof., Krankenhaus Agatharied

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: May 16, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 1206-T-SIMPLICITI-RM