Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 5:02 AM
Study NCT ID:
NCT00916994
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2009-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study for Safety and Efficacy of InSpace™ in Rotator Cuff Tear Subjects
Sponsor:
OrthoSpace Ltd.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: