Prospective Study for Safety and Efficacy of SpaceGuard™ in Rotator Cuff Tear Subjects - Full Text View

Sponsor:	BioProtect
Information provided by (Responsible Party):	BioProtect
ClinicalTrials.gov Identifier:	NCT00916994

Purpose

Title: One-arm, international, multi-center with competitive recruitment, prospective study to assess the safety and efficacy of BioProtect's SpaceGuard™ in rotator cuff tear subjects scheduled for surgery of the rotator cuff - A pivotal study

Device: BioProtect's Biodegradable Implanted Balloon (SpaceGuard)

Study population: Rotator Cuff tear subjects scheduled for arthroscopy.

Number of subjects: At least 30 and up to 70 subject for data analysis.

Number of sites: At least 4 sites in Israel and Italy.

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: 6 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 months post implantation and then 6 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 Endpoint Classification: Safety/Efficacy Study 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 BioProtect's SpaceGuard™ in Rotator Cuff Tear Subjects Scheduled for Surgery of the Rotator Cuff

Further study details as provided by BioProtect:

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: 6 months follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	July 2009
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2012 (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 BioProtect's SpaceGuard™ biodegradable 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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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

Contacts

Contact: Eliayhu Adar, MD

+972 50 8217678

adar@wolfson.health.gov.il

Locations

Israel
Wolfson Medical Center	Recruiting
Holon, Israel, 58100
Principal Investigator: Eliyahi Adar, MD

Sponsors and Collaborators

BioProtect

Investigators

Principal Investigator:

Eliyahu Adar, MD

Wolfson Medical Center

More Information

No publications provided

Responsible Party:	BioProtect
ClinicalTrials.gov Identifier:	NCT00916994 History of Changes
Other Study ID Numbers:	BP-04
Study First Received:	June 7, 2009
Last Updated:	September 4, 2011
Health Authority:	Israel: Ministry of Health

Keywords provided by BioProtect:

Rotator Cuff Tear

Additional relevant MeSH terms:

Rupture
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012