InSpace Accelerated Rehabilitation Study

Recruiting now · Not applicable

Conditions studied: Rotator Cuff Tears

In brief

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.

Key facts

Study ID

NCT05329584

Run by

Stryker Endoscopy

People needed

160

Starts

2022-02-07

Expected to finish

2026-12-01

Last updated by the study team

2025-05-29

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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