Clinical trial NCT01390038: Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
Official title: Simpliciti IDE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Generalized (Osteo)Arthritis
Post-traumatic Arthrosis of Other Joints, Upper Arm
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2011-07-08
Enrollment: 157
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Device Success Rate
timeFrame: 24 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 24 months
measure: Range of Motion
timeFrame: 24 months
measure: Strength
timeFrame: 24 months
measure: Device Parameters
timeFrame: 24 months
measure: American Shoulder and Elbow Surgeon Score
timeFrame: 24 Months
measure: Pain: Visual Analog Scale
timeFrame: 24 Months
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Saint Agnes Medical Center
state: California
city: La Mesa
country: United States
facility: Grossmont/Sharp Hospital
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Chicago
country: United States
facility: Rush Hospital
state: Illinois
city: Beverly Hills
country: United States
facility: Beverly Hills Orthopaedic Surgery
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Edina
country: United States
facility: Sports and Orthopaedic Specialists
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
city: Cooperstown
country: United States
facility: Bassett Healthcare Network Research Institute
state: New York
city: Euclid
country: United States
facility: Cleveland Clinic
state: Ohio
city: Bend
country: United States
facility: The Center
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: Knoxville Orthopaedic Clinic
state: Tennessee
city: Grafton
country: United States
facility: Aurora Medical Center - Grafton
state: Wisconsin
Study officials:
References: