InSpace™ System Implantation in a Procedure Under Local Anesthesia

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208453
• Other study ID #: IS-CL-05
• Secondary ID: 72746
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: April 2019

Study information

• Verified date: August 2019
• Source: OrthoSpace Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Device:
• InSpace Implantation
InSpace device Implantation

Locations

Country	Name	City	State
Italy	Hospital of Latisana	Latisana	Udine

Sponsors (1)

Lead Sponsor	Collaborator
OrthoSpace Ltd.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Assessment	The Safety assessment will include all device related AEs/SAEs throughout the entire study period.	24 months post implantation
Primary	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	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

External Links

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