Actively Recruiting
InSpace Accelerated Rehabilitation Study
Led by Stryker Endoscopy · Updated on 2025-05-29
160
Participants Needed
11
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
InSpace Accelerated Rehabilitation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form prior to enrollment
- Male or female aged 65 years or older
- MRI within 9 months showing full thickness massive irreparable rotator cuff tear measuring 5 cm or larger involving two or more tendons
- Functional deltoid muscle and preserved passive range of motion
- Documented pain with VAS score greater than 30 mm
- Failed at least 3 months of non-operative treatment including one or more of oral analgesics, anti-inflammatory medications, corticosteroid injections, physical therapy, activity modification, or rest
- Ability to read and understand the informed consent form
- General good health based on screening and medical history
- Independent and ambulatory with ability to comply with post-operative evaluations and data collection
- Intra-operative confirmation of full thickness tear measuring 5 cm or larger involving two or more tendons
You will not qualify if you...
- Allergy to device material (copolymer of PLA and -ε-caprolactone)
- Severe gleno-humeral or acromio-humeral arthritis
- Full thickness cartilage loss on MRI
- History of anterior or posterior shoulder subluxation or dislocation within past 5 years
- Pre-existing deltoid defect or palsy
- Major joint trauma, infection, or necrosis
- Partial thickness supraspinatus tears
- Fully reparable rotator cuff tear less than 5 cm or with retractable tendon
- Neurovascular compromise
- Complete deltoid muscle palsy
- Traumatic muscle tears of pectoralis or deltoid
- Need for concomitant subscapularis repair, labral repair, or biceps tenodesis
- Prior shoulder surgery within past year except diagnostic arthroscopy
- Bilateral condition with scheduled repair of opposite shoulder
- Major medical condition affecting quality of life (e.g., rheumatoid arthritis)
- History of drug or alcohol abuse within 12 months
- Worker's compensation case
- Involvement in health-related litigation
- Pregnant or planning pregnancy if female of childbearing potential
- Participation in another investigational study within one month or during study
- Physical or mental compromise affecting compliance
- Use of prescription narcotic pain medication for unrelated conditions
- Acute infection near surgical site
- Baseline WORC score less than 420
- Intra-operative exclusion: fully reparable rotator cuff, partial thickness supraspinatus tear, significant osteoarthritis, need for concomitant subscapularis repair, labral repair, or biceps tenodesis, coracoacromial ligament deficiency or shoulder instability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Musculoskeletal-Orthopedic Research and Education Foundation
Phoenix, Arizona, United States, 85023
Actively Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Steadman Hawkins Clinic Denver
Englewood, Colorado, United States, 80112
Actively Recruiting
4
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
5
Paley Orthopaedics & Spine
West Palm Beach, Florida, United States, 33407
Actively Recruiting
6
Emory University
Atlanta, Georgia, United States, 30329
Actively Recruiting
7
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
8
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
10
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
11
TSAOG Orthopaedics & Spine
San Antonio, Texas, United States, 78258
Actively Recruiting
Research Team
H
Hayley Taylor, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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