Accelerated rehabilitation for rotator cuff tears using the InSpace device

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 study is testing two different rehab programs for people with serious rotator cuff tears who have had surgery using the InSpace device to see which one helps them recover better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Stryker Endoscopy (industry)
• Locations: 11 sites (Phoenix, Arizona and 10 other locations)
• Trial ID: NCT05329584 on ClinicalTrials.gov

What this trial studies

This study evaluates two accelerated rehabilitation programs for patients with full thickness Massive, Irreparable Rotator Cuff Tears (MIRCTs) who have undergone an arthroscopic procedure using the InSpace device. It is a prospective, parallel group, open-label, multi-center, randomized study that aims to assess clinical outcomes of both a formalized rehabilitation program and an at-home program. The study will compare these outcomes to historical control results from the InSpace pivotal study and analyze changes in clinical outcomes from baseline. Participants will be monitored for their recovery progress and overall effectiveness of the rehabilitation approaches.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 65 and older with a confirmed diagnosis of full thickness MRCT who have failed non-operative treatments.

Not a fit: Patients with rotator cuff tears that do not meet the specified criteria or those who have not failed prior non-operative treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide improved rehabilitation strategies for patients with severe rotator cuff injuries, potentially leading to better recovery outcomes.

How similar studies have performed: Other studies have shown promise in using innovative rehabilitation techniques for rotator cuff injuries, but this specific approach with the InSpace device is relatively novel.

Eligibility criteria

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

Where this trial is running

Phoenix, Arizona and 10 other locations

• Musculoskeletal-Orthopedic Research and Education Foundation — Phoenix, Arizona, United States (RECRUITING)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (RECRUITING)
• Steadman Hawkins Clinic Denver — Englewood, Colorado, United States (RECRUITING)
• Holy Cross Hospital — Fort Lauderdale, Florida, United States (RECRUITING)
• Paley Orthopaedics & Spine — West Palm Beach, Florida, United States (RECRUITING)
• Emory University — Atlanta, Georgia, United States (RECRUITING)
• Rush University Medical Center — Chicago, Illinois, United States (RECRUITING)
• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
• Hospital for Special Surgery — New York, New York, United States (RECRUITING)
• The Rothman Institute — Philadelphia, Pennsylvania, United States (RECRUITING)
• TSAOG Orthopaedics & Spine — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Hayley Taylor, MS

Conditions: Rotator Cuff Tears