Comprehensive Nano - Post Market Clinical Follow-Up Study

April 20, 2026 updated by: Zimmer Biomet

Comprehensive Nano Post Market Data Collection

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

194

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8010
        • Privatklinik Leech
  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • Kingston General Hospital
  • South Korea
    • Gwangju
      • Gwangju, Gwangju, South Korea
        • Chonnam National University Hospital
    • Seoul
      • Seoul, Seoul, South Korea, 06351
        • Samsung Medical Centre
  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L69 3BX
        • University of Liverpool

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survivorship
Time Frame: 10 years
Kaplan Meier method
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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").
10 years
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)?"
10 years
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.
10 years
X-rays evaluated for radiolucencies, osteolysis, migration and subsidence
Time Frame: 10 years
Standard evaluation performed on both humeral and glenoid components
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Paola Vivoda, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2013

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO.CR.GE2.13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on Comprehensive Nano

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe