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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00916994
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 or older.
2. Diagnosed with Rotator Cuff tear and are scheduled for surgery.
3. X-Ray of treated shoulder with no unrelated pathology and imaging (ultrasound or MRI) showing Rotator Cuff tear.
4. Persistent pain and functional disability for at least 4 months.
5. Documented failure of conservative treatment.
6. Blood work up to two weeks before implantation as follow:
* Normal CBC
* Normal electrolytes (potassium, chloride, phosphorous, sodium)
* Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
* Platelets ≥ 100,000 cells/mm3
* Hemoglobin ≥ 10.0 g/dl
* Adequate renal function, with serum creatinine ≤ 2.0 mg/dl
* Adequate liver function, with serum bilirubin \< 2.0 mg/dl
* Adequate liver function with SGOT/SGPT \< 2.5 x the upper normal limit
* Normal values of the PT, PTT and INR tests
7. Negative for HIV and Hepatitis B or C
8. Mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements
9. For Woman of Child Bearing Potential (WOCBP), negative pregnancy test and willingness to use birth control during the study.
10. Singed Informed Consent Form.
Exclusion Criteria:
1. Evidence of significant osteoarthritis or cartilage damage in the shoulder.
2. Evidence of glenohumeral instability.
3. Previous surgeries of the shoulder .
4. Evidence of major joint trauma, infection, or necrosis in the shoulder.
5. Patients unable to provide informed consent due to language barrier or mental status.
6. Patients with a major medical condition that would affect quality of life and influence the results of the study (Including, but not limited to HIV, hepatitis, active malignancy in the past 5 years, transmural MI, CVA and other impaired neurological status, CHF or unstable angina in the past 6 months).
7. Patients unwilling to be followed for the duration of the study.
8. Acute infection requiring intravenous antibiotics at the time of screening.
9. Other shoulder pain of unknown etiology.
10. Paget's disease, osteomalacia or any other metabolic bone disease.
11. Severe diabetes mellitus requiring daily insulin management.
12. Bleeding disorders.
13. Known cognitive disorder.
14. Concurrent participation in any other clinical study.
15. Physician objection.
16. Subjects with sign of cervical root irritation.
17. Chronic lung disease
18. Trauma subjects
19. For WOCBP, a positive pregnancy test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00916994
Study Brief:
Protocol Section:
NCT00916994