NCT03423953

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P50-P75 for all trials

Timeline
52mo left

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
4 countries

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Oct 2013Jul 2030

Study Start

First participant enrolled

October 30, 2013

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2030

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

16.8 years

First QC Date

January 29, 2018

Last Update Submit

April 20, 2026

Conditions

OsteoarthritisAvascular NecrosisRheumatoid ArthritisRevisionCorrection of Functional Deformity

Keywords

osteoarthritisavascular necrosisrheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • Survivorship

    Kaplan Meier method

    10 years

Secondary Outcomes (4)

  • ASES Score (American Shoulder and Elbow Surgeons)

    10 years

  • SANE Score (Single Assessment Numeric Evaluation)

    10 years

  • Constant-Murley Score

    10 years

  • X-rays evaluated for radiolucencies, osteolysis, migration and subsidence

    10 years

Study Arms (2)

Anatomic

Patients receiving the Anatomic or Hemi verison of the Comprehensive Nano.

Device: Comprehensive Nano

Reverse

Patients who have received the Reverse version of the Comprehensive Nano.

Device: Comprehensive Nano

Interventions

Comprehensive NanoDEVICE

Patients requiring the Comprehensive Nano shoulder system.

AnatomicReverse

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Infection
  • Sepsis
  • osteomyelitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Privatklinik Leech

Graz, Styria, 8010, Austria

Location

Kingston General Hospital

Kingston, Ontario, K7L 3N6, Canada

Location

Chonnam National University Hospital

Gwangju, Gwangju, South Korea

Location

Samsung Medical Centre

Seoul, Seoul, 06351, South Korea

Location

University of Liverpool

Liverpool, Merseyside, L69 3BX, United Kingdom

Location

MeSH Terms

Conditions

OsteoarthritisOsteonecrosisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Paola Vivoda

    Zimmer Biomet

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 6, 2018

Study Start

October 30, 2013

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

CA(1)AU(1)GB(1)KR(2)