Comprehensive Shoulder System Nano IDE

NCT01936259 | Completed Results FDA Device

• 2 other identifiers: ORTHO.CA.GE1.12G110207
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 12

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).

Conditions

Joint Disease

Keywords

Shoulder; Joint; Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• American Shoulder and Elbow Surgeon's Score (ASES)

  The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.

  22+ Months

• Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation

  This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "No unanticipated device-related adverse event, and no fracture, perforation of the bone or joint dislocation, and no fracture, perforation or dissociation of the device, and no revision or removal of any component." All subject records were evaluated for each of the disqualifying factors, and all subjects that failed at least one of the endpoint measures were identified. The success rate is defined as the number of subjects at two years not meeting any of the disqualifying factors compared to the total number of cases present at two years plus all subjects considered failures without two year data.

  2 years

• Number of Shoulders With Radiographic Success

  This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "Subsidence of the humeral component \<5 mm, and migration of the humeral component \<5 mm, and no progressive lucency around the humeral component \>2 mm in two or more contiguous zones, and migration of the glenoid component \<5 mm, and no progressive lucency \>2 mm around the entire glenoid component." All subject records were evaluated by an Independent Radiographic Reviewer (IRR) at each time point for radiographic success based on these criteria.

  2 years

Secondary Outcomes (4)

• American Shoulder and Elbow Surgeon's Score (ASES)

  Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years

• Single Assessment Numeric Evaluation (SANE) Score

  6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years

• Constant Score Adjusted for Age and Gender

  Pre-operative, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years

• Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence

  2+ years

Study Arms (2)

Comprehensive Mini Humeral Stem

ACTIVE COMPARATOR

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.

Device: Mini Stem

Comprehensive Nano Humeral Component

EXPERIMENTAL

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.

Device: Nano

Interventions

Mini Stem DEVICE

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.

Comprehensive Mini Humeral Stem

Nano DEVICE

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.

Comprehensive Nano Humeral Component

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (12)

Arizona Institute for Sports, Knees, and Shoulders

Scottsdale, Arizona, 85255, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Ortho NorthEast

Fort Wayne, Indiana, 46825, United States

Location

Orthopedic Clinic

Shreveport, Louisiana, 71105, United States

Location

Towson Orthopaedic Associates

Towson, Maryland, 21204, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Buffalo

Buffalo, New York, 14214, United States

Location

Joint Implant Surgeons

New Albany, Ohio, 43054, United States

Location

Campbell Clinic Orthopaedics

Germantown, Tennessee, 38138, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Bon Secours St. Francis Medical Center

Midlothian, Virginia, 23114, United States

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Zimmer Biomet, Inc.

clinicaldirector@zimmerbiomet.com

800-613-6131

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: September 6, 2013
• Study Start: August 1, 2013
• Primary Completion: November 21, 2018
• Study Completion: September 27, 2019
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2020-01

Locations

US (12)