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Joint DiseaseNanoNCT01936259

Comprehensive Shoulder System Nano IDE

A study testing Mini Stem and Nano in people with Joint Disease, run by Zimmer Biomet at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Joint Disease
What is being tested?
Mini Stem and Nano
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
12 sitesUnited States
Study dates
Aug 2013to 27 Sep 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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 locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Buffalo

    Buffalo, New York, 14214

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Ortho NorthEast

    Fort Wayne, Indiana, 46825

  • Campbell Clinic Orthopaedics

    Germantown, Tennessee, 38138

  • Bon Secours St. Francis Medical Center

    Midlothian, Virginia, 23114

  • Joint Implant Surgeons

    New Albany, Ohio, 43054

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Arizona Institute for Sports, Knees, and Shoulders

    Scottsdale, Arizona, 85255

  • Orthopedic Clinic

    Shreveport, Louisiana, 71105

  • Towson Orthopaedic Associates

    Towson, Maryland, 21204

Other trials in United States

About this study

Official title: A Study of the Comprehensive Shoulder System With Nano Humeral Component in Total Shoulder Arthroplasty

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).

Read the 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.
Conditions
Joint Disease
Being tested
Mini Stem, Nano
Keywords
Shoulder, Joint, Osteoarthritis
Medical subject headings
Joint Diseases, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mini StemDevice

    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.

  • NanoDevice

    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.

Study groups in NCT01936259
Study groupRoleWhat they receive
Comprehensive Mini Humeral StemActive comparatorThe 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.
Receives: Device: Mini Stem
Comprehensive Nano Humeral ComponentExperimentalThe 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.
Receives: Device: Nano

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 22+ Months

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

Secondary outcomes (4)

  1. 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.

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

  2. Single Assessment Numeric Evaluation (SANE) Score

    The Single Assessment Numeric Evaluation (SANE) Score is a tool used to assess the subject's perception of their affected joint. Participants are requested to rate their shoulder function on a scale of 0 to 100, with 0 as the worst option and 100 being normal shoulder function.

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

  3. Constant Score Adjusted for Age and Gender

    The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function. The age- and gender-adjusted Constant score normalizes the raw Constant score based on the subject's age and gender. The worst score on the adjusted scale is still 0, but the greatest scores can exceed 100 based on the calculations used for normalization. The scale used in this study was described by Katolik et al.

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

  4. Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence

    All radiographs collected at all follow-up time points were analyzed by the Independent Radiographic reviewer. Subjects were assessed for the presence of radiolucencies considered to be failures of the radiographic co-primary endpoint (No progressive lucency around the humeral component >2 mm in two or more contiguous zones OR no progressive lucency >2 mm around the entire glenoid component) and for the presence of component subsidence. Subjects with the absence of failing radiolucencies and subsidence were considered successes.

    Measured: 2+ years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2013 (estimated)
  2. Study startAug 2013
  3. Primary completion21 Nov 2018
  4. Study completion27 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01936259
Sponsor's protocol ID
ORTHO.CA.GE1.12
Other IDs
G110207
Acronym
Nano
Status last verified
Jan 2020
First submitted
23 Aug 2013
Last updated
13 Jan 2020
Data monitoring committee
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Mini Stem and Nano in people with Joint Disease, run by Zimmer Biomet at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

American Shoulder and Elbow Surgeon's Score (ASES) (time frame: 22+ Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01936259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

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