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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Device: InSpace Implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Udine
    • Latisana, Udine, Italy, 33503
      • Hospital of Latisana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 50 or older.
2. Positive diagnostic MRI of the affected shoulder indicating full thickness massive irreparable RCT of at least 5cm in diameter (according to Cofield classification) including fatty infiltration grade III or IV (according to classification of Goutallier).
3. Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months.

Exclusion Criteria:

1. Known allergy to the balloon material
2. Evidence of significant osteoarthritis or cartilage damage in the shoulder
3. Evidence of gleno-humeral instability
4. Evidence of major joint trauma, infection, or necrosis in the shoulder
5. Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study.
6. Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.
7. Subjects with worker's compensation claims or other litigation claims related to the shoulder being treated in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InSpace implantation; InSpace device implantation	Device: InSpace Implantation; InSpace device Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total shoulder outcome scores (Constant and ASES)	Change in total shoulder outcome scores (Constant and ASES)at 6 month post implantattion	6 months post implanatation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Shoulder scores	Change in Total Shoulder scores and improvement compare to baseline at each time point (6W, 3m, 12m and 24m).	up to 24 months post implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment	The Safety assessment will include all device related AEs/SAEs throughout the entire study period.	24 months post implantation

Collaborators and Investigators

• Sponsor: OrthoSpace Ltd.
• Investigators: Principal Investigator: Enrico Gervasi, MD, Orthopedic Department, Latisana Hospital

Publications and helpful links

Helpful Links

• Fluoroscopy-guided biodegradable spacer implantation using local anesthesia: safety and efficacy study in patients with massive rotator cuff tears.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: June 29, 2013
• First Submitted That Met QC Criteria: August 3, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Local anesthesia; Massive Rotator Cuff Tear; Sub-acromial spacer
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: IS-CL-05; 72746 (Other Identifier: Santa Maria Della Miserecordia, Udine)