Status:
COMPLETED
Prospective Study for Safety and Efficacy of InSpace™ in Rotator Cuff Tear Subjects
Lead Sponsor:
OrthoSpace Ltd.
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Title: One-arm, international, multi-center with competitive recruitment, prospective study to assess the safety and efficacy of OrthoSpace's InSpace™ in rotator cuff tear subjects scheduled for surge...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00916994
Start Date
July 1 2009
End Date
June 1 2014
Last Update
March 11 2015
Active Locations (1)
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1
Wolfson Medical Center
Holon, Israel, 58100