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

OrthoSpace Ltd.184 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

184

Conditions

Rotator Cuff Syndrome

Interventions

InSpace sub-acromial tissue spacer systemDEVICE

Arthroscopic implantation of InSpace sub-acromial tissue spacer system

Partial repair of rotator cuffPROCEDURE

Arthroscopic partial repair of rotator cuff

Eligibility

Sex: ALLMin age: 40 YearsMax age: 100 Years

Medical Language ↔ Plain English

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 -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.

Locations (21)

Southern California Orthopedic Institute

Van Nuys, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to month 12

Secondary Outcomes

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).

Time frame: Baseline through to Month 24

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).

Time frame: Baseline to month 12

Data from ClinicalTrials.gov

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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

...and 11 more locations

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.

Time frame: Baseline to month 12

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.