Clinical trial NCT03409718: Database Retrieval for the Comprehensive Shoulder
Official title: Comprehensive Shoulder System Database Retrieval
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis of the Shoulder
Avascular Necrosis
Rheumatoid Arthritis
Prior Failed Revision
Correction of Functional Deformity
Fracture of Proximal End of Humerus
Cuff Tear Arthropathy
Keywords: Total Shoulder Arthroplasty
Medical Device
Performance
Safety
Shoulder Prosthesis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-01-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in need of a total shoulder arthroplasty which receive one of the devices in the Comprehensive Shoulder family and who meet all of the inclusion and none of the exclusion criteria.

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Implant survivorship is assessed counting the number of implant revisions
timeFrame: 10 years
Secondary outcomes:
measure: Constant Shoulder Score
timeFrame: 10 years
measure: Clinical Safety
timeFrame: 10 years
measure: Clinical Safety - Device Related
timeFrame: 10 years
Other outcomes:
Locations:
city: Towson
country: United States
facility: Acromion LLC
state: Maryland
Study officials:
References: