NCT00916994

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: OrthoSpace Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
DEVICE	SpaceGuard Balloon	Positioning of the balloon into the subacromial space between the humerus head and the acromion

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-04-01
• Completion: 2014-06-01
• First posted: 2009-06-10
• Last updated: 2015-03-11

Locations

1 site across 1 country: Israel