Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty

Simpliciti IDE Trial

The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Arthrosis of Other Joints, Upper Arm; Primary Generalized (Osteo)Arthritis
• Intervention / Treatment: Device: Simpliciti™ Shoulder System

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Saint Agnes Medical Center
    • La Mesa, California, United States, 91942
      • Grossmont/Sharp Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Hospital
  • Michigan
    • Beverly Hills, Michigan, United States, 48025
      • Beverly Hills Orthopaedic Surgery
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
  • Minnesota
    • Edina, Minnesota, United States, 55439
      • Sports and Orthopaedic Specialists
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Columbia
  • New York
    • Cooperstown, New York, United States, 13326
      • Bassett Healthcare Network Research Institute
  • Ohio
    • Euclid, Ohio, United States, 44119
      • Cleveland Clinic
  • Oregon
    • Bend, Oregon, United States, 97701
      • The Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Knoxville, Tennessee, United States, 37917
      • Knoxville Orthopaedic Clinic
  • Wisconsin
    • Grafton, Wisconsin, United States, 53024
      • Aurora Medical Center - Grafton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult subject 22 years or older
• Clinical indication for total shoulder replacement due to primary diagnosis of arthritis. Primary arthritis for this study includes osteoarthritis, and/or traumatic arthritis.
• Scapula and proximal humerus must have reached skeletal maturity
• Subject with a Constant Score ≥ 20
• Willing and able to comply with the protocol
• Willing and able to sign the informed consent (or the Legally Authorized Representative will sign for the subject)

Exclusion Criteria:

• Lack of sufficient sound bone to seat and support the implant such as:

  1. Rapid joint destruction, marked bone loss or bone resorption;
  2. Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and
  3. Osteomalacia
• Metal allergies or sensitivity, including a known allergic reaction to implant metals (e.g., nickel) or polyethylene

• Infection at or near the site of implantation, including:

  1. Glenohumeral joint infection
  2. Osteomyelitis
• Distant or systemic infection
• Medical conditions or balance impairments that could lead to falls
• Prior open shoulder surgery on the shoulder to be treated in the study including failed rotator cuff surgery, but excluding successful shoulder arthroscopy
• Any full thickness rotator cuff tear at the time of surgery or a nonfunctional rotator cuff
• Excessive glenoid bone loss defined by preoperative computed tomography (CT) scans of the shoulder which show insufficient glenoid bone, or insufficient bone identified at the time of surgery
• Metabolic disorders which may impair bone function
• Nonfunctional deltoid muscle
• Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint)
• Known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
• Currently, or within the last 6 months, or planning to be on chemotherapy or radiation
• Currently taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
• Female subjects who are pregnant or planning to become pregnant within the study period
• In the surgeon's opinion, the subject is unable to understand the study or be compliant with the follow up or have a history of non-compliance with medical advice
• History of any cognitive or mental health status that would interfere with study participation
• Alcohol or drug abuse
• Engages in manual labor or sports activities that could affect shoulder outcome
• Currently enrolled in any clinical research study that might interfere with the current study endpoints

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simpliciti™ Shoulder System; The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.	Device: Simpliciti™ Shoulder System; Total shoulder arthroplasty system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success Rate	A subject is a Patient Success at 24-months if: There is NO continuous radiolucent line around the prosthesis; and; The adjusted Constant Score is > 85 (successful outcome); and; They did not have revision surgery; and; They did not have a system-related serious adverse event.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Simple Shoulder Test 1 (worse) - 12 (best)	24 months
Range of Motion	Elevation in the scapula plane; Internal rotation with arm at the side; External rotation with arm at the side	24 months
Strength	Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier	24 months
Device Parameters	Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty: Migration; Osteolysis; Subsidence	24 months
American Shoulder and Elbow Surgeon Score	0 (worst) - 100 (best)	24 Months
Pain: Visual Analog Scale	0 (best) - 10 (worst)	24 Months

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: G100284