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

Phase 3

Completed

Conditions: Primary Generalized (Osteo)Arthritis
Post-traumatic Arthrosis of Other Joints, Upper Arm

Interventions: Device: Simpliciti™ Shoulder System

Registration Number: NCT01390038

Lead Sponsor: Stryker Trauma and Extremities

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 157

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Simpliciti™ Shoulder System	Simpliciti™ Shoulder System	The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.

Primary Outcome Measures

Name	Time	Method
Device Success Rate	24 months	A subject is a Patient Success at 24-months if: 1. There is NO continuous radiolucent line around the prosthesis; and 2. The adjusted Constant Score is \> 85 (successful outcome); and 3. They did not have revision surgery; and 4. They did not have a system-related serious adverse event.

Secondary Outcome Measures

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

Trial Locations

Locations (14): Saint Agnes Medical Center
🇺🇸
Fresno, California, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
Beverly Hills Orthopaedic Surgery
🇺🇸
Beverly Hills, Michigan, United States
Munson Medical Center
🇺🇸
Traverse City, Michigan, United States
Knoxville Orthopaedic Clinic
🇺🇸
Knoxville, Tennessee, United States
Grossmont/Sharp Hospital
🇺🇸
La Mesa, California, United States
Rush Hospital
🇺🇸
Chicago, Illinois, United States
Bassett Healthcare Network Research Institute
🇺🇸
Cooperstown, New York, United States
Cleveland Clinic
🇺🇸
Euclid, Ohio, United States
Sports and Orthopaedic Specialists
🇺🇸
Edina, Minnesota, United States
Aurora Medical Center - Grafton
🇺🇸
Grafton, Wisconsin, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
University of Missouri-Columbia
🇺🇸
Columbia, Missouri, United States
The Center
🇺🇸
Bend, Oregon, United States