InSpace Accelerated Rehabilitation Study (iAccelerate)
Rotator Cuff Tears
About this trial
This is an interventional treatment trial for Rotator Cuff Tears
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
Sites / Locations
- Musculoskeletal-Orthopedic Research and Education FoundationRecruiting
- UC DenverRecruiting
- Holy Cross HospitalRecruiting
- Paley Orthopaedics & SpineRecruiting
- Emory UniversityRecruiting
- Rush University Medical CenterRecruiting
- Mayo ClinicRecruiting
- Hospital for Special SurgeryRecruiting
- The Rothman InstituteRecruiting
- TSAOG Orthopaedics & SpineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group I
Group II
InSpace device + accelerated rehabilitation in a formalized program (FP)
InSpace device + accelerated rehabilitation in an at-home program (AHP)