Comprehensive Shoulder System Nano IDE

Zimmer Biomet

Status: Completed

Conditions: Joint Disease

Treatments: Device: Mini Stem; Device: Nano

Study type: Interventional

Funder types: Industry

Identifiers

NCT01936259

ORTHO.CA.GE1.12

G110207 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 258 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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258 participants in 2 patient groups

Comprehensive Mini Humeral Stem

Active Comparator group

Description:

The Comprehensive® Shoulder System with mini stem component, which will be the control device for this clinical investigation and was 510(k) cleared under K060692 on May 30, 2006. The humeral stem component is manufactured from Ti6Al4V alloy. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The proximal region of the bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy, while the distal portion is polished. Seventeen stem diameters are available - 4 mm to 20 mm, in 1-mm increments.

Treatment:

Device: Mini Stem

Comprehensive Nano Humeral Component

Experimental group

Description:

The stemless humeral component is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. A small groove is included just below the taper to accept an inserter/impactor. The bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, and 40 mm.

Treatment:

Device: Nano