Comprehensive Nano - Post Market Clinical Follow-Up Study

N/AActive Not RecruitingNCT03423953

Zimmer Biomet194 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

194

Conditions

Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Revision Correction of Functional Deformity

Interventions

Comprehensive NanoDEVICE

Patients requiring the Comprehensive Nano shoulder system.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Privatklinik Leech

Graz, Styria, Austria

Kingston General Hospital

Kingston, Ontario, Canada

Chonnam National University Hospital

Gwangju, South Korea

Samsung Medical Centre

Seoul, South Korea

Outcomes

Primary Outcomes

Survivorship

Kaplan Meier method

Time frame: 10 years

Secondary Outcomes

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").

Time frame: 10 years

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)?"

Time frame: 10 years

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.

Time frame: 10 years

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

Standard evaluation performed on both humeral and glenoid components

Time frame: 10 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.