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

Primary Purpose

Rotator Cuff Tear

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

SpaceGuard Balloon

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator Cuff Tear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wolfson Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SpaceGuard Balloon implantation

Arm Description

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00916994

First Posted

June 7, 2009

Last Updated

March 10, 2015

Sponsor

OrthoSpace Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00916994

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OrthoSpace Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tear

Keywords

Rotator Cuff Tear

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SpaceGuard Balloon implantation

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

SpaceGuard Balloon

Intervention Description

Positioning of the balloon into the subacromial space between the humerus head and the acromion

Primary Outcome Measure Information:

Title

Time Frame

12-36 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eliyahu Adar, MD

Organizational Affiliation

Wolfson Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wolfson Medical Center

City

Holon

ZIP/Postal Code

58100

Country

Israel

12. IPD Sharing Statement

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

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