InSpace™ System Implantation in a Procedure Under Local Anesthesia
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|ClinicalTrials.gov Identifier: NCT02208453|
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Device: InSpace Implantation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|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|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||April 2019|
Experimental: InSpace implantation
InSpace device implantation
Device: InSpace Implantation
InSpace device Implantation
- Change in total shoulder outcome scores (Constant and ASES) [ Time Frame: 6 months post implanatation ]Change in total shoulder outcome scores (Constant and ASES)at 6 month post implantattion
- Change in Total Shoulder scores [ Time Frame: up to 24 months post implantation ]Change in Total Shoulder scores and improvement compare to baseline at each time point (6W, 3m, 12m and 24m).
- Safety Assessment [ Time Frame: 24 months post implantation ]The Safety assessment will include all device related AEs/SAEs throughout the entire study period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208453
|Hospital of Latisana|
|Latisana, Udine, Italy, 33503|
|Principal Investigator:||Enrico Gervasi, MD||Orthopedic Department, Latisana Hospital|