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

NCT02493660 | Completed Results DMC

• 1 other identifier: CLD-OR-010
• Study Type: interventional
• Target: 184
• Locations: 2 countries
• Sites: 21

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).

Conditions

Rotator Cuff Syndrome

Keywords

Massive Rotator Cuff Tear; Arthroscopy; Shoulder Joint; Rotator cuff partial repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

  Baseline through to Month 24

• Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP)

  Baseline to month 12

• Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP)

  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

  Baseline through to month 24

• 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

  Baseline through to month 24

Study Arms (2)

InSpace implantation

EXPERIMENTAL

Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation

Device: InSpace sub-acromial tissue spacer system

Tendon Repair

ACTIVE COMPARATOR

Arthroscopic partial repair of rotator cuff

Procedure: Partial repair of rotator cuff

Interventions

InSpace sub-acromial tissue spacer system DEVICE

Arthroscopic implantation of InSpace sub-acromial tissue spacer system

InSpace implantation

Partial repair of rotator cuff PROCEDURE

Arthroscopic partial repair of rotator cuff

Tendon Repair

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known allergy to the device material (copolymer of PLA and -ε-caprolactone)
• Evidence of the following conditions:
• significant gleno-humeral or acromiohumeral arthritis
• full thickness cartilage loss as seen on MRI
• gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)
• pre-existing deltoid defect or deltoid palsy
• major joint trauma, infection or necrosis
• partial thickness tears of the supraspinatous
• 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

Sponsors & Collaborators

• OrthoSpace Ltd.: lead

Study Sites (21)

Southern California Orthopedic Institute

Van Nuys, California, 91405, United States

Location

University of Colorado

Denver, Colorado, 80222, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33334, United States

Location

Midwest Orthopedics at RUSH

Chicago, Illinois, 60612, United States

Location

Rockford Orthopedic Associates

Rockford, Illinois, 51107, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205-1911, United States

Location

MedStar Union Memorial Orthopaedics

Baltimore, Maryland, 21218, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02166, United States

Location

NYU

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Buffalo Buffalo

New York, New York, 14260, United States

Location

Upstate Orthopedics

Syracuse, New York, 13057, United States

Location

Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health

Cincinnati, Ohio, 45209, United States

Location

The Ohio State University

Ohio City, Ohio, 43210, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19152, United States

Location

University Orthopedic Center

State College, Pennsylvania, 16801, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Fowler Kennedy Sport Medicine Clinic

London, Ontario, Canada

Location

Roth McFarlane Hand and Upper Limb Center

London, Ontario, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

Results Point of Contact

• Title: Colleen Roden, Director, Clinical Operations
• Organization: Stryker Company

colleen.roden@stryker.com

1 931 267 2041

Study Officials

• Assaf Dekel, MD

  Ortho-Space

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 9, 2015
• Study Start: June 26, 2015
• Primary Completion: February 29, 2020
• Study Completion: March 17, 2020
• Last Updated: June 15, 2022
• Results First Posted: July 22, 2021

Record last verified: 2022-06

Locations

US (18); CA (3)