Comprehensive Nano - Post Market Clinical Follow-Up Study

Active, not recruiting

• Conditions: Avascular Necrosis; Revision; Osteoarthritis; Rheumatoid Arthritis; Correction of Functional Deformity
• Interventions: Device: Comprehensive Nano

• Registration Number: NCT03423953
• Lead Sponsor: Zimmer Biomet

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.

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 Timeline

• Study Start: 2013-10-30
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2030-07-31
• Study Completion: 2030-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 194

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anatomic	Comprehensive Nano	Patients receiving the Anatomic or Hemi verison of the Comprehensive Nano.
Reverse	Comprehensive Nano	Patients who have received the Reverse version of the Comprehensive Nano.

Primary Outcome Measures

Name	Time	Method
Survivorship	10 years	Kaplan Meier method

Secondary Outcome Measures

Name	Time	Method
Constant-Murley Score	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.
X-rays evaluated for radiolucencies, osteolysis, migration and subsidence	10 years	Standard evaluation performed on both humeral and glenoid components
ASES Score (American Shoulder and Elbow Surgeons)	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").
SANE Score (Single Assessment Numeric Evaluation)	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)?"

Trial Locations

Locations (5)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Samsung Medical Centre; 🇰🇷 Seoul, Korea, Republic of

University of Liverpool; 🇬🇧 Liverpool, Merseyside, United Kingdom

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Privatklinik Leech; 🇦🇹 Graz, Styria, Austria