Prospective Study for Safety and Efficacy of InSpace™ in Rotator Cuff Tear Subjects

Launched by ORTHOSPACE LTD. · Jun 9, 2009

Keywords

ClinConnect Summary

The OrthoSpace's InSpace™ biodegradable sub-acromial spacer (balloon) will be inserted at the end of the routine arthroscopy between the humerus head and the acromion.

Gender

ALL

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.