Back to search results

InSpace Accelerated Rehabilitation for Rotator Cuff Tears

This study is looking at two different rehabilitation programs for people with large, irreparable rotator cuff tears (a common shoulder injury). You might be eligible if you are 65 years or older and have a full thickness rotator cuff tear confirmed by an MRI within the last 9 months. The study is testing how well the InSpace Subacromial Tissue Spacer device works with either a formal rehabilitation program or an at-home program. Researchers will measure your shoulder function using the American Shoulder and Elbow Score (ASES) over 12 months to see if these programs lead to good results. The study aims to enroll 160 participants, but its current status is unclear.

Study design
This is a randomized, open-label study comparing two rehabilitation programs with the InSpace device, involving about 160 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your shoulder function will be measured from the start of the study through 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05329584

InSpace Accelerated Rehabilitation Study

Recruiting
NAAges 65+InterventionalTreatment
Stryker Endoscopy
~160 participants
Updated 2025-05-29 on ClinicalTrials.gov
What's tested:InSpace Subacromial Tissue Spacer

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in American Shoulder and Elbow (ASES) Score
Measured over Day 0 through Month 12

Conditions

Rotator Cuff Tears

Explore related trials

Rupture of rotator cuff of shoulder

NCT05329584

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Emory University

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Holy Cross Hospital

    Fort Lauderdale, Floridastudy coordinator listed

    Recruiting

  • Hospital for Special Surgery

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Mayo Clinic

    Rochester, Minnesotastudy coordinator listed

    Recruiting

  • Musculoskeletal-Orthopedic Research and Education Foundation

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • Paley Orthopaedics & Spine

    West Palm Beach, Floridastudy coordinator listed

    Recruiting

  • Rush University Medical Center

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • Steadman Hawkins Clinic Denver

    Englewood, Coloradostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Colleen Roden, MS · STUDY_DIRECTOR · Stryker Endoscopy

Who to contact

Hayley Taylor, MS
[email protected]
805-705-4206
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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
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

What this trial measures

  • Change in American Shoulder and Elbow (ASES) ScoreDay 0 through Month 12

    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).