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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Rotator Cuff Tear

Clinical Trial Details

NCT number	NCT00916994
Study type	Interventional
Source	OrthoSpace Ltd.
Contact
Status	Completed
Phase	N/A
Start date	July 2009
Completion date	June 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms