InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.

Full-thickness Rotator Cuff Tear Clinical Trial

Official title:

A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace™ Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02208440
• Other study ID #: IS-CL-02-UK
• Status: Terminated
• Phase: N/A
• Start date: July 2014
• Est. completion date: January 2019

Study information

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

Clinical Trial Summary

This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

Description:

This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

The effectiveness will be assessed by comparing the shoulder outcome scores of each treatment arm ( ASES, Constant and Quick DASH) from pre-operation (baseline) up to 2 years post-operation, with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).

The safety will be asses by comparing the Adverse event rate between the treatment arms.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

Main Inclusion Criteria:

• Age 40 or older.

• Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT involving more than one tendon.

• Persistent pain and functional disability of the affected shoulder for at least 3 months.

Main Exclusion Criteria :

• Known allergy to the balloon material (copolymer of PLA and -?-caprolactone).

• Evidence of significant osteoarthritis or cartilage damage in the shoulder

• Evidence of gleno-humeral instability

• Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy

• Evidence of major joint trauma, infection, or necrosis in the shoulder

• Partial-thickness tears of the rotator cuff

Related Conditions & MeSH terms

• Full-thickness Rotator Cuff Tear
• Rotator Cuff Injuries

Intervention

Procedure:
• Best Repair of torn Rotator Cuff

Device:
• InSpace™ system

Locations

Country	Name	City	State
United Kingdom	Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery	Wigan	Hall Lane, Appley Bridge

Sponsors (1)

Lead Sponsor	Collaborator
OrthoSpace Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the Shoulder Score		baseline and 6 months