Clinical trial NCT01936259: Comprehensive Shoulder System Nano IDE
Official title: A Study of the Comprehensive Shoulder System With Nano Humeral Component in Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Disease
Keywords: Shoulder
Joint
Osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2013-09-06
Enrollment: 258
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).

Detailed description: The purpose of this clinical investigation is to establish the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty. Safety and efficacy of the device will be measured by collection and analysis of the following data at the two-year or greater time point (22 months post-operative or longer):

1. American Shoulder and Elbow Surgeons (ASES) Score
2. Single Assessment Numeric Evaluation (SANE)
3. Constant Score
4. Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence
5. Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events.

Eligibility criteria: Inclusion Criteria:

* Patients for whom the surgeon has confirmed intraoperatively, has no cyst \> 1cm and not more than one cyst at the implantation site
* Patients with non-inflammatory degenerative joint disease including osteoarthritis.
* Patients where the device will be used in the correction of a functional deformity (deformities preventing congruent articulation of the glenohumeral joint)
* Patients with pain and/or loss of function in the shoulder for whom other treatment modalities have been unsuccessful.
* Patients requiring unilateral or staged bilateral shoulder arthroplasty
* Patient must be anatomically and structurally suited to receive the implants (humeral neck must be of sufficient diameter to implant at least the smallest nano humeral component and the humeral neck is intact).
* Patients who are 21-90 years of age at the time of surgery and have reached skeletal maturity.
* Patients with an ASES score ≤ 40.

Exclusion Criteria:

* Patients diagnosed with avascular necrosis or post-traumatic arthritis of the humeral head
* Patients found at the time of intraoperative examination to have a single cyst \>1 cm in size or multiple cysts at the implantation site
* Patient presents with shoulder joint infection, sepsis, osteomyelitis or distant foci of infections which may spread to the implant site.
* Patients with cuff tear arthropathy.
* Patients who have undergone a Hemi-, Total, or Reverse Total Shoulder arthroplasty in the affected shoulder.
* Patient presents with a malunion or non-union of the tuberosities of the proximal humerus.
* Patients with osteoporosis, osteomalacia, rheumatoid arthritis, metabolic disorders of bone, muscle or connective tissue, gross deformity or any other condition of the proximal humerus (defined as severe destruction or deformity of the proximal humerus that precludes placement of the device) that in the Investigator's medical judgment could compromise implant fixation or bone healing.
* Rapid bone destruction, marked bone loss or bone resorption apparent on roentgenogram.
* Patients with neurologic or other disorders that would either affect the stability of the shoulder prosthesis, i.e., Charcot's joint, uncontrolled seizures, etc., or would affect their capability or willingness to return to the clinic for assessments and/or follow directions.
* Bone cancer, either primary or secondary, that affects the shoulder.
* Patients presenting with symptoms of chronic steroid use. (oral steroids for a chronic condition for 12 months prior to and including the date of surgery)
* Patients with a life expectancy of less than three years.
* Patients diagnosed with severe shoulder instability
* Patients diagnosed with subscapularis incompetence
* Patients diagnosed with any condition that may limit their ability to complete the consent form or would affect their capability or willingness to return to the clinic for assessments and/or follow directions (i.e. mental illness)
* Patients with known metal allergy
* Patients who refuse to sign the Institutional Review Board (IRB) approved consent form
* Patients who are found intraoperatively to require a specific treatment and are unable to be randomized.

Primary outcomes:
measure: American Shoulder and Elbow Surgeon's Score (ASES)
timeFrame: 22+ Months
measure: Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation
timeFrame: 2 years
measure: Number of Shoulders With Radiographic Success
timeFrame: 2 years
Secondary outcomes:
measure: American Shoulder and Elbow Surgeon's Score (ASES)
timeFrame: Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years
measure: Single Assessment Numeric Evaluation (SANE) Score
timeFrame: 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years
measure: Constant Score Adjusted for Age and Gender
timeFrame: Pre-operative, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years
measure: Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence
timeFrame: 2+ years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Institute for Sports, Knees, and Shoulders
state: Arizona
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Fort Wayne
country: United States
facility: Ortho NorthEast
state: Indiana
city: Shreveport
country: United States
facility: Orthopedic Clinic
state: Louisiana
city: Towson
country: United States
facility: Towson Orthopaedic Associates
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New Albany
country: United States
facility: Joint Implant Surgeons
state: Ohio
city: Germantown
country: United States
facility: Campbell Clinic Orthopaedics
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Midlothian
country: United States
facility: Bon Secours St. Francis Medical Center
state: Virginia
Study officials:
References: