Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. This study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness rotator cuff tear. The primary outcome is change in Constant Score (CS) at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in CS, Visual Analogue Score (VAS) pain score, American Shoulder and Elbow Surgeons (ASES) score, Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH), Simple Shoulder Test (SST), and functional evaluations including Range of Motion (ROM) at 4, 12, 24 and 52 weeks after administration and structural evaluation using MRI at 24 and 52 weeks after injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
166
Ultrasound-guided intratendinous injection of allogeneic fibroblasts (TPX-115)
Ultrasound-guided intratendinous placebo injection
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGChange in shoulder score of Constant score (CS)
The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)
Time frame: 24 weeks
Change in shoulder score of Constant score (CS)
The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25).
Time frame: 4, 12, 52 weeks
hange in pain score of Visual Analogue Scale (VAS)
VAS pain score is measured on a scale of 0 (no pain) to 10 (worst pain imaginable).
Time frame: 4, 12, 24, 52 weeks
Change of American Shoulder and Elbow Surgeons (ASES) Shoulder Score
ASES shoulder score is derived from the visual analogue scale score for pain and the activities of daily living score. The total score(100 maximum points) is weighted 50% for pain and 50% for function.
Time frame: 4, 12, 24, 52 weeks
Change of Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure
The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
Time frame: 4, 12, 24, 52 weeks
Change in Simple Shoulder Test (SST) Score
SST assesses functional disability of the shoulder (function related to pain, function/strength and Range of Motion).
Time frame: 4, 12, 24, 52 weeks
Change in Range of Motion (ROM)
Measurement of ROM for forward elevation, external rotation at 90º abduction, external rotation at side and internal rotation at back.
Time frame: 4, 12, 24, 52 weeks
Change in Ellman grade on Magnetic Resonance Image (MRI)
Ellman grade is assessed by an independent evaluator.
Time frame: 24, 52 weeks
Change of tendinosis on MRI
Tendinosis is assessed with tendinosis grading system by an independent evaluator. (0: normal, 1: mild, 2: moderate, 3: marked)
Time frame: 24, 52 weeks
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