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

NCT ID: NCT02493660

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-26
• Study Completion Date: 2020-03-17

Brief 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).

Detailed 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.

Conditions

Rotator Cuff Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

InSpace implantation

Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation

Group Type: EXPERIMENTAL

InSpace sub-acromial tissue spacer system

Intervention Type: DEVICE

Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Tendon Repair

Arthroscopic partial repair of rotator cuff

Group Type: ACTIVE_COMPARATOR

Partial repair of rotator cuff

Intervention Type: PROCEDURE

Arthroscopic partial repair of rotator cuff

Interventions

InSpace sub-acromial tissue spacer system

Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Intervention Type: DEVICE

Partial repair of rotator cuff

Arthroscopic partial repair of rotator cuff

Intervention Type: PROCEDURE

Eligibility Criteria

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.

Exclusion Criteria

• Known allergy to the device material (copolymer of PLA and -ε-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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OrthoSpace Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Assaf Dekel, MD

Role: STUDY_DIRECTOR

Ortho-Space

Locations

Southern California Orthopedic Institute

Van Nuys, California, United States

University of Colorado

Denver, Colorado, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Midwest Orthopedics at RUSH

Chicago, Illinois, United States

Rockford Orthopedic Associates

Rockford, Illinois, United States

Tulane University School of Medicine

New Orleans, Louisiana, United States

Johns Hopkins

Baltimore, Maryland, United States

MedStar Union Memorial Orthopaedics

Baltimore, Maryland, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

NYU

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

University of Buffalo Buffalo

New York, New York, United States

Upstate Orthopedics

Syracuse, New York, United States

Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health

Cincinnati, Ohio, United States

The Ohio State University

Ohio City, Ohio, United States

Rothman Institute

Philadelphia, Pennsylvania, United States

University Orthopedic Center

State College, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Fowler Kennedy Sport Medicine Clinic

London, Ontario, Canada

Roth McFarlane Hand and Upper Limb Center

London, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CLD-OR-010

Identifier Type: -

Identifier Source: org_study_id