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Rotator Cuff TearsiAccelerateNCT05329584

InSpace Accelerated Rehabilitation Study

A study testing InSpace Subacromial Tissue Spacer in people with Rotator Cuff Tears, run by Stryker Endoscopy at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Rotator Cuff Tears
What is being tested?
InSpace Subacromial Tissue Spacer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
11 sitesUnited States
Study dates
7 Feb 2022to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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

Who cannot join

  • 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
Show all 40Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hayley Taylor, MS contact

805-705-4206

hayley.taylor@stryker.com

11 sites in 1 country

United States11 sites, 11 recruiting

  • Emory University

    Atlanta, Georgia, 30329

    Isabelle Vernon, isabelle.m.vernon@emory.edu

    Eric Wagner, MD

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Kavita Ahuja, kavita.ahuja@rushortho.com

    Mukesh Ahuja, Mukesh.Ahuja@rushortho.com

    Recruiting

  • Steadman Hawkins Clinic Denver

    Englewood, Colorado, 80112

    Lauren Heylmun, LAUREN.HEYLMUN@CUANSCHUTZ.EDU

    James Genuario

    Recruiting

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

    David Henderson, David.Henderson002@holy-cross.com

    Ross Wodika, MD

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Dana Garrison, DLGarrison@uams.edu

    Lawrence O'Malley

    Recruiting

  • Hospital for Special Surgery

    New York, New York, 10021

    Anthony Finocchiaro, finocchiaroa@hss.edu

    Michael Fu, MD

    Recruiting

  • The Rothman Institute

    Philadelphia, Pennsylvania, 19107

    Thema Nicholson, thema.nicholson@rothmanortho.com

    Joseph Abboud, MD

    Recruiting

  • Musculoskeletal-Orthopedic Research and Education Foundation

    Phoenix, Arizona, 85023

    Wafa Mohsin, wafa.mohsin@more-foundation.org

    Michael Amini, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Lindsey Hobbs, hobbs.lindsey@mayo.edu

    Joaquin Sanchez Sotelo

    Recruiting

  • TSAOG Orthopaedics & Spine

    San Antonio, Texas, 78258

    Amanda Strickland, astrickland@brioresearch.org

    Robert Hartzler, MD

    Recruiting

  • Paley Orthopaedics & Spine

    West Palm Beach, Florida, 33407

    Janice Schuck, janice.schuck@tenehealth.com

    Jonathan Levy, MD

    Recruiting

Other trials in United States

About this study

Official title: An Assessment of Two Accelerated Rehabilitation Programs for Use With the InSpaceTM Subacromial Tissue Spacer System in the Treatment of Full-thickness Massive, Irreparable Rotator Cuff Tears

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.

Read the detailed description

Study Objectives:

Primary:

  • To evaluate clinical outcomes of both a formalized or an at-home rehabilitation program when used in conjunction with the InSpace device as compared to the corresponding InSpace Pivotal study results.
  • To demonstrate consistency of each intervention group with the corresponding historical control study results.
  • To demonstrate that comparable clinical outcomes can be achieved for each intervention group.

Secondary:

  • Change in clinical outcomes compared to baseline.
Being tested
InSpace Subacromial Tissue Spacer
Medical subject headings
Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InSpace Subacromial Tissue SpacerDevice

    Rotator Cuff Tear Treatment

Study groups in NCT05329584
Study groupRoleWhat they receive
Group IExperimentalInSpace device + accelerated rehabilitation in a formalized program (FP)
Receives: Device: InSpace Subacromial Tissue Spacer
Group IIExperimentalInSpace device + accelerated rehabilitation in an at-home program (AHP)
Receives: Device: InSpace Subacromial Tissue Spacer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in American Shoulder and Elbow (ASES) Score

    This is a subject self-report questionnaire and Investigator assessment questionnaire. The subject portion collects information on activities of daily living (i.e., 10 questions). The Investigator assessment portion documents ROM (forward elevation/flexion, external rotation, internal rotation, cross-body adduction), signs, strength, and instability. ASES minimal clinical important difference (MCID) and substantial clinical benefit (SCB) have been previously described for the ASES score in patients undergoing rotator cuff repair as 11.1 and 17.5, respectively.

    Change in American Shoulder and Elbow Surgeons (ASES) Score will be expressed as the percentages demonstrating a minimal clinical important difference (MCID; ASES ≥ 11.1) and the substantial clinical benefit (SCB; ASES ≥ 17.5) in ASES from baseline at Month 12. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome).

    Measured: Day 0 through Month 12

Secondary outcomes (11)

  1. Safety Assessment

    • Safety will be evaluated by type, frequency, severity, and relatedness of adverse events to study intervention at each follow-up visit through Month 24

    Measured: Day 0 through Month 24

  2. Change in Western Ontario Rotator Cuff (WORC) Score

    Change in WORC Score from baseline. Minimum value: 2,100, Maximum value: 0 (with a lower score indicating a better outcome).

    This is a subject self-report questionnaire that is a disease-specific Quality of Life Measurement Tool specifically designed to evaluate quality of life in persons with pathology of the rotator cuff. It is comprised of 21 items in 5 domains (i.e., physical symptoms, sports and recreation, work, lifestyle, emotions).

    Measured: Day 0 through Month 24

  3. Change in Constant Score (CS) Outcome Score

    Change in CS Outcome Score from baseline. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome).

    This is a self-reported questions as well as Investigator or designee performed assessment of the shoulder. The tool is divided into four subscales: pain, activities of daily living, strength and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder.

    Measured: Day 0 through Month 24

  4. Change in EuroQol 5-Dimensions Questionnaire (EQ-5D-5L) Score

    Change in EQ-5D-5L Score from baseline. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome).

    This is a subject self-report questionnaire to measure health-related quality of life (HRQOL). It consists of 5 questions capturing the subject's current health across five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). It also includes a numerical visual analogue scale (EQ-VAS).

    Measured: Day 0 through Month 24

  5. Change in Visual Analog Scale (VAS) Score

    Change in VAS Score from baseline. This is a subject self-report questionnaire to measure pain. The patient marks on the line the point that they feel represents their perception of their current state. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. (An extreme amount of pain would be considered a worse outcome)

    Measured: Day 0 through Month 24

  6. Change in Range of Motion (ROM) Score

    Change in ROM Score from baseline. Minimum value: 0, Maximum value: 180 (with a higher score indicating a better outcome).

    Measured: Day 0 through Month 24

  7. Change in Single Assessment Numeric Evaluation (SANE) Score

    Change in SANE from baseline. Minimum value: 0%, Maximum value: 100% (with 100% being normal).

    This is a subject self-report questionnaire to measure function. The patient marks on the line the point that they feel represents their perception of their current state of functional improvement. Example: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"

    Measured: Day 0 through Month 24

  8. Patient's satisfaction with their procedure

    Patient Satisfaction Score at Month 12 and Month 24.

    This is a single-question to evaluate the patients' current state of satisfaction. Responses are binary with Yes or No answers. ('Yes' would be considered a positive outcome)

    Measured: Month 12 and Month 24

  9. Costing

    Costs associated with all visits

    Measured: Day 0 through Month 24

  10. Time to Recovery

    Time to recovery by cumulative time between discharge and return to driving

    Measured: Day 0 through Month 24

  11. Analgesia Use

    Analgesia use (drug and frequency)

    Measured: Day 0 through Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2022
  2. Study start7 Feb 2022
  3. Primary completionApr 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05329584
Sponsor's protocol ID
SYK-SM-2021-01
Acronym
iAccelerate
Status last verified
May 2025
First submitted
17 Mar 2022
Last updated
29 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing InSpace Subacromial Tissue Spacer in people with Rotator Cuff Tears, run by Stryker Endoscopy at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hayley Taylor, MS (805-705-4206, hayley.taylor@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in American Shoulder and Elbow (ASES) Score (time frame: Day 0 through Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05329584.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.

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