A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

Rotator Cuff Syndrome Clinical Trial

Official title:

A Prospective, Single Blinded, Multi-center, Randomized, Controlled, Pivotal Study to Assess the Safety and Effectiveness of the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493660
• Other study ID #: CLD-OR-010
• Status: Completed
• Phase: N/A
• Start date: June 26, 2015
• Est. completion date: March 17, 2020

Study information

• Verified date: June 2022
• Source: OrthoSpace Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).

Description:

This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled, pivotal study evaluating the safety and effectiveness of the InSpace™ device as a primary surgical treatment for full thickness MRCT in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: March 17, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

Main Inclusion Criteria:

• Positive diagnostic imaging by MRI of the index shoulder indicating a full thickness Massive Rotator Cuff Tear (MRCT), measuring = 5 cm in diameter involving = two tendons (confirmed Intra-operatively)

• Functional deltoid muscle and preserved passive range of motion on physical examination

• Documented VAS score of > 30 mm pain

• Failed non-operative treatment of at least 4 months

• Patient in general good health,independent, and can comply with all post-operative evaluations and visits.

Main Exclusion Criteria:

• Known allergy to the device material (copolymer of PLA and -e-caprolactone)

• Evidence of the following conditions:

1. significant gleno-humeral or acromiohumeral arthritis

2. full thickness cartilage loss as seen on MRI

3. gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)

4. pre-existing deltoid defect or deltoid palsy

5. major joint trauma, infection or necrosis

6. partial thickness tears of the supraspinatous

7. fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or < 4 cm2) with retractable tendon that can be fully repaired]

• The subject requires concomitant subscapularis repair and/or labral repair

• Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy

• The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder

• Major medical condition that could affect quality of life and influence the results of the study (e.g. HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)

• Documented evidence of a history of drug/alcohol abuse within 12 months of enrollment

• The subject's condition represents a worker's compensation case

• The subject is currently involved in a health-related litigation procedure

• Females of child-bearing potential who are pregnant or breastfeeding or plan to become pregnant during the course of the study

• Concurrent participation in any other investigational clinical study one month prior to enrollment or during the entire study period

• The subject has implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing a MRI scan or has claustrophobia that would inhibit ability to undergo a MRI scan .

• The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up

• The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition

• The subject currently has an acute infection in the area surrounding the surgical site.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Syndrome

Intervention

Device:
• InSpace sub-acromial tissue spacer system
Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Procedure:
• Partial repair of rotator cuff
Arthroscopic partial repair of rotator cuff

Locations

Country	Name	City	State
Canada	Fowler Kennedy Sport Medicine Clinic	London	Ontario
Canada	Roth McFarlane Hand and Upper Limb Center	London	Ontario
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
United States	Johns Hopkins	Baltimore	Maryland
United States	MedStar Union Memorial Orthopaedics	Baltimore	Maryland
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Midwest Orthopedics at RUSH	Chicago	Illinois
United States	Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health	Cincinnati	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	NYU	New York	New York
United States	University of Buffalo Buffalo	New York	New York
United States	The Ohio State University	Ohio City	Ohio
United States	Rothman Institute	Philadelphia	Pennsylvania
United States	Rockford Orthopedic Associates	Rockford	Illinois
United States	University Orthopedic Center	State College	Pennsylvania
United States	Upstate Orthopedics	Syracuse	New York
United States	Southern California Orthopedic Institute	Van Nuys	California

Sponsors (1)

Lead Sponsor	Collaborator
OrthoSpace Ltd.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in the Per Protocol Population With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears From Baseline to Month 12 With no SSSIs and no SADEs.	The primary composite effectiveness endpoint was defined as achievement of improvement for the Western Ontario Rotator Cuff (WORC) score (=275 points) and American Shoulder and Elbow Society (ASES) score (=6.4 points) by week 6 and maintenance at month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).; The improvement of points of the Western Ontario Rotator Cuff (WORC) of at least 275 (point scale of 0-2100:lower score is better) and American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.	Baseline to month 12
Secondary	Composite Endpoint of WORC Improvement =275 and ASES Improvement =6.4 at Week 6 Maintained at Month 24 no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (Pre-specified). Composite WORC ASES and Safety to M24	Composite Endpoint Per Protocol Population (PP) of WORC Improvement = 275 and ASES Improvement = 6.4 from baseline at Week 6 Maintained at Month 24 with no Subsequent Secondary Surgical Intervention (SSSI) and no Serious Adverse Device Effect (SADEs) (pre-specified).	Baseline through to Month 24
Secondary	Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP)	The secondary effectiveness endpoint was defined as a composite component-level success at Month 12 for Western Ontario Rotator Cuff (WORC) total score improvement (=275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs).	Baseline to month 12
Secondary	Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP)	The secondary endpoint was defined as a composite component-level success for American Shoulder and Elbow Surgeons ( ASES) compared at baseline to Month 12 without subsequent secondary surgical intervention (SSSI) or serious adverse device effects (SADEs)..; The total score improvement of (= 6.4 points) (scale of 0-100:higher score is better) from baseline in the two groups, InSpace and Partial Repair.	Baseline to month 12
Secondary	Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. WORC	The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Western Ontario Rotator Cuff (WORC) total score improvement (=275) (scale of 0-2100:lower score is better) in the two groups, InSpace and Partial Repair.	Baseline through to month 24
Secondary	Mean Change From Baseline to Month 24 in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears Through to Month 24. ASES	Mean change in American Shoulder and Elbow Surgeons (ASES) score from baseline to month 24.; The improvement of points of the American Shoulder and Elbow Society (ASES) at least 6.4 (point scale of 0-100:higher score is better) reflect the required number of points in improvement for treatment to be considered successful.	Baseline through to month 24
Secondary	Mean Change From Baseline to Month 24 for Constant-Murley (CS) in the Intent To Treat Population (ITT) With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears	The secondary effectiveness endpoint was defined as mean change from baseline to Month 24 for Constant-Murley (CS) Shoulder Outcome score (where the scale of 0-100:higher score is better) in the two groups, InSpace and Partial Repair.	Baseline to month 24
Secondary	The Mean Change From Baseline to Month 24 for EQ-5D-5L for Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears	The secondary effectiveness endpoint was defined as change in baseline to Month 24 for Quality of Life (EQ-5D-5L) (scale of 0-100: lower score better) in the two groups, InSpace and Partial Repair.	Baseline through to month 24
Secondary	Mean Change From Baseline to Month 24 for VAS in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears	The secondary effectiveness endpoint was defined as the mean change from baseline at Month 24 for Visual Analogue Scale (VAS) (scale of 0-100:lower score is better) in the two groups, InSpace and Partial Repair.	Baseline through to month 24
Secondary	Mean Change From Baseline to Month 24 for ASES ROM in the Intent To Treat (ITT) Population With Available Data With Surgical Treatment Success of the InSpace Device as a Primary Surgical Treatment for Full-thickness Massive Rotator Cuff Tears	The secondary effectiveness endpoint was defined as mean change from baseline at Month 24 for American Shoulder and Elbow Surgeons (ASES) range of motion (ROM)-physician reported portion. (scale of 0-180 Degrees: higher score is better) in the two groups, InSpace and Partial Repair.	Baseline through to month 24