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

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Device: SpaceGuard Balloon

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Holon, Israel, 58100
    • Wolfson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SpaceGuard Balloon implantation	Device: SpaceGuard Balloon; Positioning of the balloon into the subacromial space between the humerus head and the acromion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	12-36 months follow-up

Collaborators and Investigators

• Sponsor: OrthoSpace Ltd.
• Investigators: Principal Investigator: Eliyahu Adar, MD, Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 7, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 10, 2009

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 10, 2015
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Rotator Cuff Tear
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: BP-04