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

Primary Purpose

Full-thickness Rotator Cuff Tear

Status

Terminated

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Best Repair of torn Rotator Cuff

InSpace™ system

About this trial

This is an interventional treatment trial for Full-thickness Rotator Cuff Tear focused on measuring Full-thickness/Massive Rotator Cuff Tear, Sub-acromial spacer

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -θ-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

Sites / Locations

Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Best Repair of torn Rotator Cuff

InSpace™ system

Arm Description

Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.

Subjects will undergo surgical intervention (usually arthroscopy or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.

Outcomes

Primary Outcome Measures

The change in the Shoulder Score

Secondary Outcome Measures

Full Information

NCT ID

NCT02208440

First Posted

August 3, 2014

Last Updated

June 3, 2020

Sponsor

OrthoSpace Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02208440

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Terminated

Why Stopped

Enrollment target has not achieved due to very slow and low recruitment rate

Study Start Date

July 2014 (Actual)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OrthoSpace Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 .

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Full-thickness Rotator Cuff Tear

Keywords

Full-thickness/Massive Rotator Cuff Tear, Sub-acromial spacer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

The patient is blinded to the treatment type

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Best Repair of torn Rotator Cuff

Arm Type

Sham Comparator

Arm Description

Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.

Arm Title

InSpace™ system

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Best Repair of torn Rotator Cuff

Intervention Type

Device

Intervention Name(s)

InSpace™ system

Primary Outcome Measure Information:

Title

The change in the Shoulder Score

Time Frame

baseline and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -θ-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

Facility Information:

Facility Name

Wigan and Leigh NHS Foundation Trust: Upper Limb & Trauma Surgery

City

Wigan

State/Province

Hall Lane, Appley Bridge

ZIP/Postal Code

WN69EP

Country

United Kingdom

12. IPD Sharing Statement

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

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