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.
Study Objectives: Primary: • To evaluate clinical outcomes of both a formalized or an at-home rehabilitation program when used in conjunction with the InSpace device as compared to the corresponding InSpace Pivotal study results. * To demonstrate consistency of each intervention group with the corresponding historical control study results. * To demonstrate that comparable clinical outcomes can be achieved for each intervention group. Secondary: • Change in clinical outcomes compared to baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Rotator Cuff Tear Treatment
Musculoskeletal-Orthopedic Research and Education Foundation
Phoenix, Arizona, United States
RECRUITINGUniversity of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
RECRUITINGChange in American Shoulder and Elbow (ASES) Score
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).
Time frame: Day 0 through Month 12
Safety Assessment
• Safety will be evaluated by type, frequency, severity, and relatedness of adverse events to study intervention at each follow-up visit through Month 24
Time frame: Day 0 through Month 24
Change in Western Ontario Rotator Cuff (WORC) Score
Change in WORC Score from baseline. Minimum value: 2,100, Maximum value: 0 (with a lower score indicating a better outcome). This is a subject self-report questionnaire that is a disease-specific Quality of Life Measurement Tool specifically designed to evaluate quality of life in persons with pathology of the rotator cuff. It is comprised of 21 items in 5 domains (i.e., physical symptoms, sports and recreation, work, lifestyle, emotions).
Time frame: Day 0 through Month 24
Change in Constant Score (CS) Outcome Score
Change in CS Outcome Score from baseline. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome). This is a self-reported questions as well as Investigator or designee performed assessment of the shoulder. The tool is divided into four subscales: pain, activities of daily living, strength and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder.
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Steadman Hawkins Clinic Denver
Englewood, Colorado, United States
RECRUITINGHoly Cross Hospital
Fort Lauderdale, Florida, United States
RECRUITINGPaley Orthopaedics & Spine
West Palm Beach, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGRush University Medical Center
Chicago, Illinois, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGHospital for Special Surgery
New York, New York, United States
RECRUITINGThe Rothman Institute
Philadelphia, Pennsylvania, United States
RECRUITING...and 1 more locations
Time frame: Day 0 through Month 24
Change in EuroQol 5-Dimensions Questionnaire (EQ-5D-5L) Score
Change in EQ-5D-5L Score from baseline. Minimum value: 0, Maximum value: 100 (with a higher score indicating a better outcome). This is a subject self-report questionnaire to measure health-related quality of life (HRQOL). It consists of 5 questions capturing the subject's current health across five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). It also includes a numerical visual analogue scale (EQ-VAS).
Time frame: Day 0 through Month 24
Change in Visual Analog Scale (VAS) Score
Change in VAS Score from baseline. This is a subject self-report questionnaire to measure pain. The patient marks on the line the point that they feel represents their perception of their current state. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. (An extreme amount of pain would be considered a worse outcome)
Time frame: Day 0 through Month 24
Change in Range of Motion (ROM) Score
Change in ROM Score from baseline. Minimum value: 0, Maximum value: 180 (with a higher score indicating a better outcome).
Time frame: Day 0 through Month 24
Change in Single Assessment Numeric Evaluation (SANE) Score
Change in SANE from baseline. Minimum value: 0%, Maximum value: 100% (with 100% being normal). This is a subject self-report questionnaire to measure function. The patient marks on the line the point that they feel represents their perception of their current state of functional improvement. Example: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Time frame: Day 0 through Month 24
Patient's satisfaction with their procedure
Patient Satisfaction Score at Month 12 and Month 24. This is a single-question to evaluate the patients' current state of satisfaction. Responses are binary with Yes or No answers. ('Yes' would be considered a positive outcome)
Time frame: Month 12 and Month 24
Costing
Costs associated with all visits
Time frame: Day 0 through Month 24
Time to Recovery
Time to recovery by cumulative time between discharge and return to driving
Time frame: Day 0 through Month 24
Analgesia Use
Analgesia use (drug and frequency)
Time frame: Day 0 through Month 24