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

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.

Inclusion criteria

• Age 18 or older.
• Diagnosed with Rotator Cuff tear and are scheduled for surgery.
• X-Ray of treated shoulder with no unrelated pathology and imaging (ultrasound or MRI) showing Rotator Cuff tear.
• Persistent pain and functional disability for at least 4 months.
• Documented failure of conservative treatment.
• 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
• Negative for HIV and Hepatitis B or C
• Mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements
• For Woman of Child Bearing Potential (WOCBP), negative pregnancy test and willingness to use birth control during the study.
• Singed Informed Consent Form.

Exclusion criteria

• Evidence of significant osteoarthritis or cartilage damage in the shoulder.
• Evidence of glenohumeral instability.
• Previous surgeries of the shoulder .
• Evidence of major joint trauma, infection, or necrosis in the shoulder.
• Patients unable to provide informed consent due to language barrier or mental status.
• 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).
• Patients unwilling to be followed for the duration of the study.
• Acute infection requiring intravenous antibiotics at the time of screening.
• Other shoulder pain of unknown etiology.
• Paget's disease, osteomalacia or any other metabolic bone disease.
• Severe diabetes mellitus requiring daily insulin management.
• Bleeding disorders.
• Known cognitive disorder.
• Concurrent participation in any other clinical study.
• Physician objection.
• Subjects with sign of cervical root irritation.
• Chronic lung disease
• Trauma subjects
• For WOCBP, a positive pregnancy test.