Prospective Study for Safety and Efficacy of SpaceGuard™ in Rotator Cuff Tear Subjects
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.
|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|
- 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 ]
|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)|
|Experimental: SpaceGuard Balloon implantation||
Device: SpaceGuard Balloon
Positioning of the balloon into the subacromial space between the humerus head and the acromion
The BioProtect's SpaceGuard™ biodegradable balloon will be inserted at the end of the routine arthroscopy between the humerus head and the acromion.
|Contact: Eliayhu Adar, MD||+972 50 firstname.lastname@example.org|
|Wolfson Medical Center||Recruiting|
|Holon, Israel, 58100|
|Principal Investigator: Eliyahi Adar, MD|
|Principal Investigator:||Eliyahu Adar, MD||Wolfson Medical Center|