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

Withdrawn

• Conditions: Shoulder Osteoarthritis

• Registration Number: NCT02452957
• Lead Sponsor: Stryker Trauma and Extremities

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-16
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-25
• Status Verified: 2017-03
• Last Update Submitted: 2017-10-12
• Last Update Posted: 2017-10-13
• Study Start: 2020-01
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with device related adverse events as a measure of safety	24 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Krankenhaus Agatharied; 🇩🇪 Hausham, Germany