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NCT Number: NCT03423953

Comprehensive Nano - Post Market Clinical Follow-Up Study

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Connective Tissue Diseases Correction of Functional Deformity Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Revision Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Privatklinik Leech, Graz, Styria, Austria

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Nano

Device

Patients requiring the Comprehensive Nano shoulder system.

Primary outcomes

  1. Survivorship

    Time frame: 10 years

    Kaplan Meier method

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

Comprehensive Nano Post Market Data Collection

Important dates

Study start
2013
Primary completion
2030
Study completion
2030
First posted
Feb 6, 2018
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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