Clinical trial NCT02493660: A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Syndrome
Keywords: Massive Rotator Cuff Tear
Arthroscopy
Shoulder Joint
Rotator cuff partial repair
Lead sponsor: OrthoSpace Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-09
Enrollment: 184
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Baseline to month 12
Secondary outcomes:
measure: 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
timeFrame: Baseline through to Month 24
measure: Composite Endpoint Component Level Success for WORC at Month 12 Compared to Baseline in the Per Protocol Population (PP)
timeFrame: Baseline to month 12
measure: Composite Endpoint Component Level Success for ASES at Month 12 Compared to Baseline in the Per Protocol Population (PP)
timeFrame: Baseline to month 12
measure: 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
timeFrame: Baseline through to month 24
measure: 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
timeFrame: Baseline through to month 24
measure: 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
timeFrame: Baseline to month 24
measure: 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
timeFrame: Baseline through to month 24
measure: 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
timeFrame: Baseline through to month 24
measure: 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
timeFrame: Baseline through to month 24
Other outcomes:
Locations:
city: Van Nuys
country: United States
facility: Southern California Orthopedic Institute
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Chicago
country: United States
facility: Midwest Orthopedics at RUSH
state: Illinois
city: Rockford
country: United States
facility: Rockford Orthopedic Associates
state: Illinois
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Baltimore
country: United States
facility: MedStar Union Memorial Orthopaedics
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: NYU
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: University of Buffalo Buffalo
state: New York
city: Syracuse
country: United States
facility: Upstate Orthopedics
state: New York
city: Cincinnati
country: United States
facility: Cincinnati SportsMedicine and Orthopaedic Center - Mercy Health
state: Ohio
city: Ohio City
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedic Center
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: London
country: Canada
facility: Fowler Kennedy Sport Medicine Clinic
state: Ontario
city: London
country: Canada
facility: Roth McFarlane Hand and Upper Limb Center
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ortho-Space
name: Assaf Dekel, MD
role: STUDY_DIRECTOR
References: