ClinicalTrials.gov
ClinicalTrials.gov Menu

Comprehensive Nano - PMCF Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03423953
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.

Condition or disease Intervention/treatment
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Revision Correction of Functional Deformity Device: Comprehensive Nano

Detailed Description:

The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head.

This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.


Study Type : Observational
Estimated Enrollment : 194 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Nano Post Market Data Collection
Actual Study Start Date : October 30, 2013
Estimated Primary Completion Date : July 31, 2030
Estimated Study Completion Date : July 31, 2030

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Anatomic
Patients receiving the Anatomic or Hemi verison of the Comprehensive Nano.
Device: Comprehensive Nano
Patients requiring the Comprehensive Nano shoulder system.

Reverse
Patients who have received the Reverse version of the Comprehensive Nano.
Device: Comprehensive Nano
Patients requiring the Comprehensive Nano shoulder system.




Primary Outcome Measures :
  1. Survivorship [ Time Frame: 10 years ]
    Kaplan Meier method


Secondary Outcome Measures :
  1. ASES Score (American Shoulder and Elbow Surgeons) [ Time Frame: 10 years ]
    Improvement in this score from preop to 10 year follow-up. This score includes 2 scales: 1 scale for pain, from 0 to 10 where 0 stands for "no pain at all" and 10 for "pain as bad as it can be". The second scale is for the stability of the shoulder, from 0 to 10 (0 stands for "very stable" and 10 for "very unstable").

  2. SANE Score (Single Assessment Numeric Evaluation) [ Time Frame: 10 years ]
    Improvement in this score from preop to 10 year follow-up. This is a simple, single-question, patient-based shoulder function assessment tool: "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"

  3. Constant-Murley Score [ Time Frame: 10 years ]
    Improvement in this score from preop to 10 year follow-up. This is a 100-point score. Higher scores indicate a better outcome.

  4. X-rays evaluated for radiolucencies, osteolysis, migration and subsidence [ Time Frame: 10 years ]
    Standard evaluation performed on both humeral and glenoid components



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients in need of an uncemented shoulder arthroplasty and who meet all of the inclusion and none of the exclusion criteria.
Criteria

Inclusion Criteria:

  • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
  • Rheumatoid arthritis
  • Revision where other devices or treatments have failed
  • Correction of functional deformity.
  • Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate
  • Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate

Exclusion Criteria:

  • Infection
  • Sepsis
  • osteomyelitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423953


Contacts
Contact: Emilie Rohmer emilie.rohmer@zimmerbiomet.com

Locations
Austria
Privatklinik Leech Recruiting
Graz, Styria, Austria, 8010
Contact: Rolf Michael KRIFTER, MD         
Canada, Ontario
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 3N6
Contact: Ryan Bicknell, MD         
France
Hospial Lapeyronie Recruiting
Montpellier, Languedoc-Roussillon, France, 34000
Contact: Michel Chammas, MD         
Korea, Republic of
Chonnam National University Hospital Active, not recruiting
Gwangju, Korea, Republic of
Samsung Medical Centre Active, not recruiting
Seoul, Korea, Republic of, 06351
United Kingdom
University of Liverpool Recruiting
Liverpool, Merseyside, United Kingdom, L69 3BX
Contact: Frostick Simon, Prof.         
Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: Paola Vivoda Zimmer Biomet

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03423953     History of Changes
Other Study ID Numbers: ORTHO.CR.GE2.13
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Zimmer Biomet:
osteoarthritis
avascular necrosis
rheumatoid arthritis

Additional relevant MeSH terms:
Osteonecrosis
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases