Comprehensive Nano - Post Market Clinical Follow-Up Study

Rheumatoid Arthritis Clinical Trial

Official title:

Comprehensive Nano Post Market Data Collection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03423953
• Other study ID #: ORTHO.CR.GE2.13
• Status: Active, not recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Correction of Functional Deformity
• Necrosis
• Osteoarthritis
• Revision
• Rheumatoid Arthritis

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