Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT02084693
Eligibility Criteria:
Inclusion Criteria:
Patients / cases to be included in this study shall utilize the following inclusion criteria:
1. Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse shoulder configuration.
2. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
3. Grossly deficient rotator cuff with severe arthropathy and/or
1. Previously failed shoulder joint replacement with a grossly deficient rotator cuff.
2. Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
3. Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or
4. Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Exclusion Criteria:
* The exclusion criteria are the same as the indications stated in the cleared labeling for the device:
Absolute contraindications include infection, sepsis, and osteomyelitis.
Relative contraindications include:
1. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
2. Osteoporosis.
3. Metabolic disorders which may impair bone formation.
4. Osteomalacia.
5. Distant foci of infections which may spread to the implant site.
6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT02084693
Study Brief:
Protocol Section:
NCT02084693