NCT02208453

InSpace™ System Implantation in a Procedure Under Local Anesthesia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: OrthoSpace Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
DEVICE	InSpace Implantation	InSpace device Implantation

Timeline

• Start date: 2013-01-01
• Primary completion: 2018-06-01
• Completion: 2019-04-01
• First posted: 2014-08-05
• Last updated: 2019-08-28

Locations

1 site across 1 country: Italy