Database Retrieval for the Comprehensive Shoulder

Rheumatoid Arthritis Clinical Trial

Official title:

Comprehensive Shoulder System Database Retrieval

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03409718
• Other study ID #: ORTHO.CR.EX003
• Status: Active, not recruiting
• Start date: February 24, 2011
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products. The primary objective of the retrieval is to collect data that will contribute to the post market surveillance requirements for this product and will provide feedback to design engineers, support marketing efforts and publications, and answer potential questions form reimbursement agencies.

Description:

The Comprehensive Shoulder System has been cleared by the FDA via premarket notifications. No experimental or investigational surgical techniques or devices will be used in this study. All devices and products will be used in accordance with their instructions for use and/or approved labeling. The aim of the Comprehensive Shoulder System is to improve shoulder function and reduce pain. One site will be used for this database retrieval. The number of patients involved will depend upon the size of the Comprehensive database available at Acromion, LLC.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have one of the following indications:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
• Need to obtain pain relief and improve function
• Ability and willingness of the patient to follow instructions, including control of weight and activity level
• A good nutritional state of the patient
• The patient must have reached full skeletal maturity

Exclusion Criteria:

• Absolute contraindications include infection, sepsis, and osteomyelitis.
• Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
• Osteoporosis.
• Metabolic disorders which may impair bone formation.
• Osteomalacia.
• Distant foci of infections which may spread to the implant site.
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Related Conditions & MeSH terms

• Avascular Necrosis
• Correction of Functional Deformity
• Cuff Tear Arthropathy
• Fracture of Proximal End of Humerus
• Necrosis
• Osteoarthritis of the Shoulder
• Prior Failed Revision
• Rheumatoid Arthritis
• Rotator Cuff Tear Arthropathy

Intervention

Device:
• Biomet Comprehensive Shoulder System
Total shoulder system designed to provide intraoperative flexibility for surgeons with unmatched humeral stem options, and infinite humeral head offset possibilities while meeting the growing demand for ease of glenoid preparation through a streamlined, low-profile, cannulated instrument platform

Locations

Country	Name	City	State
United States	Acromion LLC	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survivorship is assessed counting the number of implant revisions	Implant survivorship will be documented by assessing the number of implant revisions occurring throughout the course of the study.	10 years
Secondary	Constant Shoulder Score	The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.	10 years
Secondary	Clinical Safety	Clinical safety is assessed through documentation of complications occurring during the course of the study.	10 years
Secondary	Clinical Safety - Device Related	Clinical safety is assessed through documentation of device-related events occurring during the course of the study.	10 years