🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT03409718
Active, not recruiting Observational

Database Retrieval for the Comprehensive Shoulder

NCT03409718 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Observational
Started
2011-02-24
Last updated
2026-07-10

Condition(s) studied

Osteoarthritis of the ShoulderAvascular NecrosisRheumatoid ArthritisPrior Failed RevisionCorrection of Functional DeformityFracture of Proximal End of HumerusCuff Tear Arthropathy

Investigational drug(s) / intervention(s)

Biomet Comprehensive Shoulder System

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Acromion LLC Towson Maryland

More Zimmer Biomet trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03409718 on ClinicalTrials.gov ↗ ← All trials in the USA