Rotator Cuff Tear Clinical Trial
Official title:
A Single Arm, Open-label, Prospective, Study to Assess the Feasibility, Efficacy and Safety of InSpace™ Device Implantation in a Procedure Under Local Anesthesia for a Treatment of Subjects With Massive, Irreparable Rotator Cuff Tear
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.
A single arm, open-label, prospective, study to assess the feasibility, efficacy and safety
of InSpace™ device implantation in a procedure under local anesthesia for a treatment of
subjects with massive, irreparable rotator cuff tear.
Subjects with radiological confirmed massive RCT who are eligible per inclusion/exclusion
criteria, will be enrolled for the study treatment.
Subjects will undergo surgical intervention under local anesthesia , fluoroscopic and/ or
arthroscopic visualization of InSpace™ implantation.
Subjects will then be followed for safety and efficacy for a 24 months following the
implantation.
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device
implantation in a surgical procedure under local anesthesia using arthroscopic and/or
fluoroscopic visualization of the affected shoulder.
The efficacy will be assess by using Constant and ASES outcome score The Constant and the
ASES will be completed by the investigator at each study visit .The patient will complete the
patient self-evaluation part of the ASES at each study visit.
The Safety assessment will be conducted by collecting all device related AEs/SAEs throughout
the entire study period.
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