Database Retrieval for the Comprehensive Shoulder
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis, Orthopedic |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/24/2019 |
| Start Date: | February 24, 2011 |
| End Date: | May 2026 |
Comprehensive Shoulder System Database Retrieval
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.
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.
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.
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.
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.
We found this trial at
1
site
