Recruiting

InSpace

Sponsor:

Stryker Endoscopy

Code:

NCT05329584

Conditions

Rotator Cuff Tears

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

InSpace Subacromial Tissue Spacer

Study Details

Brief summary:

This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator Cuff Tears (MIRCTs) performed during an arthroscopic procedure.

Conditions

Rotator Cuff Tears

Study ID

NCT05329584

Start date

Feb 7, 2022

Status verified date

May, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

Subjects MUST meet ALL the following criteria to be included in the study:

  • The subject has signed the IRB approved Informed Consent Form (ICF) specific to this study prior to enrollment
  • Is male or female ≥ sixty-five (65) years of age
  • Positive diagnostic imaging by MRI within 9 months of enrollment of the index shoulder indicating a full thickness MRCT:

  • Measuring ≥ 5 cm in diameter
  • Involving ≥ two tendons
  • Functional deltoid muscle and preserved passive range of motion on physical examination
  • Documented VAS score > 30 mm pain
  • Failed non-operative treatment of at least 3 months from the initial treatment to include one or more of the following:

  • Oral analgesics
  • Anti-inflammatory medication (e.g., ibuprofen, naproxen)
  • Corticosteroid injection(s)
  • Physical therapy
  • Activity modification
  • Rest (sling used)
  • Must be able to read and understand the approved Informed Consent Form (written and oral)
  • Must be in general good health (as determined by the Investigator) based on screening assessments and medical history
  • Must be independent, ambulatory, and can comply with all post-operative evaluations, visits, and electronic database collection

Intra-operative Inclusion Criteria

Subjects MUST meet the following criteria to be randomized in the study:

  • Full thickness tear
  • Tear size ≥ 5 cm in diameter
  • Tear involving ≥ two tendons

Exclusion Criteria:

Subjects will be excluded from the study, if they meet ANY of the following individual exclusion criteria:

  • Known allergy to the device material (copolymer of PLA (poly (lactic acid) and -ε-caprolactone)
  • Evidence of the following conditions:

  • Severe gleno-humeral or acromio-humeral arthritis
  • Full thickness cartilage loss as seen on MRI
  • History within the past 5 years of anterior or posterior shoulder subluxation or dislocation as determined by history, examination, or radiographic findings
  • Pre-existing deltoid defect or deltoid palsy
  • Major joint trauma, infection, or necrosis
  • Partial thickness tears of the supraspinatus
  • Fully reparable rotator cuff tear \[Tear of less than 5 cm in diameter (or < 4 cm2) with retractable tendon that can be fully repaired\]
  • Known neurovascular compromise
  • Complete deltoid muscle palsy
  • Traumatic muscle tears of the pectoralis or deltoid
  • The subject requires concomitant:

  • Subscapularis repair
  • Labral repair of any type
  • Biceps tenodesis
  • 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., rheumatoid arthritis)
  • The subject has documented evidence of a history (e.g., liver testing) 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 plan to become pregnant.
  • Concurrent participation in an investigational clinical study one month prior to enrollment or during the entire study period
  • 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.
  • Baseline WORC score less than 420

Intra-operative Exclusion Criteria:

Subjects will not be randomized and will be terminated from the study if they meet ANY of the following individual intra-operative exclusion criteria:

  • Rotator cuff is/presents with:

  • Fully reparable with adequate tissue and muscle quality (equivalent to Goutallier stage 1 or 2)
  • Partial thickness tear of the supraspinatus
  • Evidence of significant osteoarthritis
  • The subject requires concomitant:

  • Subscapularis repair
  • Labral repair of any type
  • Biceps tenodesis
  • Coracoacromial ligament functional deficiency or shoulder instability is identified

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group I

InSpace device + accelerated rehabilitation in a formalized program (FP)

experimental: Group II

InSpace device + accelerated rehabilitation in an at-home program (AHP)

Interventions

InSpace Subacromial Tissue Spacer

Rotator Cuff Tear Treatment

Primary outcome measure

  • Change in American Shoulder and Elbow (ASES) Score [ Time Frame: Day 0 through Month 12 ]

Central Contacts and Locations

Central contacts

Hayley Taylor, MS

805-705-4206hayley.taylor@stryker.com

Locations

Musculoskeletal-Orthopedic Research and Education Foundation

Recruiting

Phoenix, Arizona, United States, 85023

Contacts

Wafa Mohsin

wafa.mohsin@more-foundation.org

Principal Investigator:

Michael Amini, MD

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Dana Garrison

DLGarrison@uams.edu

Principal Investigator:

Lawrence O'Malley

Steadman Hawkins Clinic Denver

Recruiting

Englewood, Colorado, United States, 80112

Contacts

Lauren Heylmun

LAUREN.HEYLMUN@CUANSCHUTZ.EDU

Principal Investigator:

James Genuario

Holy Cross Hospital

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

David Henderson

David.Henderson002@holy-cross.com

Principal Investigator:

Ross Wodika, MD

Paley Orthopaedics & Spine

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Janice Schuck

janice.schuck@tenehealth.com

Principal Investigator:

Jonathan Levy, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Isabelle Vernon

isabelle.m.vernon@emory.edu

Principal Investigator:

Eric Wagner, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Kavita Ahuja

kavita.ahuja@rushortho.com

Mukesh Ahuja

Mukesh.Ahuja@rushortho.com

Principal Investigator:

Nikhil Verma, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Lindsey Hobbs

hobbs.lindsey@mayo.edu

Principal Investigator:

Joaquin Sanchez Sotelo

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Anthony Finocchiaro

finocchiaroa@hss.edu

Principal Investigator:

Michael Fu, MD

The Rothman Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Thema Nicholson

thema.nicholson@rothmanortho.com

Principal Investigator:

Joseph Abboud, MD

TSAOG Orthopaedics & Spine

Recruiting

San Antonio, Texas, United States, 78258

Contacts

Amanda Strickland

astrickland@brioresearch.org

Principal Investigator:

Robert Hartzler, MD

More Information

Sponsor

Stryker Endoscopy

Last update posted

May 29, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Stryker Endoscopy on 2025-05-29.