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

Shoulder Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02452957
• Other study ID #: 1206-T-SIMPLICITI-RM
• Status: Withdrawn
• Phase: N/A
• First received: May 16, 2015
• Last updated: October 12, 2017
• Start date: January 2020
• Est. completion date: January 2022

Study information

• Verified date: March 2017
• Source: Tornier, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Shoulder Osteoarthritis

Locations

Country	Name	City	State
Germany	Krankenhaus Agatharied	Hausham

Sponsors (1)

Lead Sponsor	Collaborator
Tornier, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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