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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OrthoSpace Ltd.
ClinicalTrials.gov Identifier:
NCT00916994
First received: June 7, 2009
Last updated: March 10, 2015
Last verified: June 2013
History of Changes
  Purpose

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 surgery of the rotator cuff - A pivotal study

Device: OrthoSpace's Biodegradable Implanted Balloon (InSpace)

Study population: Rotator Cuff tear subjects scheduled for arthroscopy.

Number of subjects: Up to 70 subject for data analysis.

Number of sites: At least 4 sites in Israel.

Main Inclusion criteria: Informed consent, diagnosed with Rotator Cuff tear.

Main Exclusion criteria: Former surgery on affected shoulder, sever illness, significant shoulder co morbidities.

Follow up period: 12 months. Visits at hospital before discharge at 1-2 days post implantation, 7-10 days post implantation, 3 weeks post implantation, 6 weeks post implantation, 3,6 and 12 months post implantation.

Primary goal: To assess the safety of the SpaceGuard in Rotator Cuff tear subjects.

Secondary goals: To assess the effectiveness of the SpaceGuard in the study population. The effectiveness will be assessed by terms of good positioning of the SpaceGuard and subsequent follow-up non migration, surgeon satisfaction, pain relief and time to pain relief, Range of Motion (ROM) and time to ROM with the SpaceGuard.

Primary end point: Serious Adverse Event rate related to the device and/or system complication.

Secondary end points: Surgeon dissatisfaction following the deployment of SpaceGuard, migration of the balloon shown by ultrasound/ X-ray/MRI at relevant follow-up visits, lost of ROM and pain enhancement.


Condition Intervention
Rotator Cuff Tear Device: SpaceGuard Balloon

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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 Surgery of the Rotator Cuff

Resource links provided by NLM:

MedlinePlus related topics: Tears
U.S. FDA Resources

Further study details as provided by OrthoSpace Ltd.:

Primary Outcome Measures:
  • The study's primary goal is to assess the safety of the SpaceGuard and implantation procedure, in the study population. Safety of the SpaceGuard will be assessed by reporting system related adverse events. [ Time Frame: 12-36 months follow-up ]
Enrollment: 58
Study Start Date: July 2009
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SpaceGuard Balloon implantation Device: SpaceGuard Balloon
Positioning of the balloon into the subacromial space between the humerus head and the acromion

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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916994

Locations
Israel
Wolfson Medical Center
Holon, Israel, 58100
Sponsors and Collaborators
OrthoSpace Ltd.
Investigators
Principal Investigator: Eliyahu Adar, MD Wolfson Medical Center
  More Information

Responsible Party: OrthoSpace Ltd.
ClinicalTrials.gov Identifier: NCT00916994     History of Changes
Other Study ID Numbers: BP-04
Study First Received: June 7, 2009
Last Updated: March 10, 2015

Keywords provided by OrthoSpace Ltd.:
Rotator Cuff Tear

ClinicalTrials.gov processed this record on June 23, 2017