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

NCT02452957 | Withdrawn

• 1 other identifier: 1206-T-SIMPLICITI-RM
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in the Range of Motions (ROM) as a measure of effectiveness

  24 months

• Change in the Constant Score as a measure of effectiveness

  24 months

• Change in the DASH Score as a measure of improvement in the patients' Quality of Life

  24 months

• Change in humeral cortical thickness as an evaluation of Stress Shielding

  24 months

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (1)

Krankenhaus Agatharied

Hausham, 83734, Germany

Location

Study Officials

• Steve A. Erickson

  Stryker Trauma and Extremities

  STUDY DIRECTOR

• Ulrich Brunner, MD, Prof.

  Krankenhaus Agatharied

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2015
• First Posted: May 25, 2015
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: October 13, 2017

Record last verified: 2017-03

Locations

DE (1)