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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03423953
Other study ID # ORTHO.CR.GE2.13
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 30, 2013
Est. completion date July 31, 2030

Study information

Verified date October 2023
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 194
Est. completion date July 31, 2030
Est. primary completion date July 31, 2030
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Comprehensive Nano
Patients requiring the Comprehensive Nano shoulder system.

Locations

Country Name City State
Austria Privatklinik Leech Graz Styria
Canada Kingston General Hospital Kingston Ontario
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Samsung Medical Centre Seoul
United Kingdom University of Liverpool Liverpool Merseyside

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Austria,  Canada,  Korea, Republic of,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survivorship Kaplan Meier method 10 years
Secondary ASES Score (American Shoulder and Elbow Surgeons) 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
Secondary SANE Score (Single Assessment Numeric Evaluation) 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
Secondary Constant-Murley Score 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
Secondary X-rays evaluated for radiolucencies, osteolysis, migration and subsidence Standard evaluation performed on both humeral and glenoid components 10 years
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