Prospective Study for Safety and Efficacy of InSpace™ in Rotator Cuff Tear Subjects
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 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 OrthoSpace's InSpace™ 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: 12-36 months follow-up ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (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 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.