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 American Shoulder and Elbow Surgeons (ASES) score at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in Visual Analogue Score (VAS) pain score, functional evaluations including Range of Motion (ROM), Constant Score (CS), ASES score and Simple Shoulder Test (SST) at 4, 12 and 24 weeks after administration and structural evaluation using MRI at 24 weeks after injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
49
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
Seoul National University Hospital
Seoul, South Korea
Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)
ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and activities of daily living score. The total score - maximum of 100 points - is weighted 50% for pain and 50% for function.
Time frame: 24 weeks
Change in shoulder score of American Shoulder and Elbow Surgeons (ASES)
ASES shoulder score is derived from the Visual Analogue Scale (VAS) score for pain and the activities of daily living score. The total score - maximum of points - is weighted 50% for pain and 50% for function.
Time frame: 4, 12 weeks
Change 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 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 weeks
Change in Constant score (CS)
The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)
Time frame: 4, 12, 24 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 weeks
Change in tear size on Magnetic Resonance Image (MRI)
Tear size is assessed by an independent evaluator.
Time frame: 24 weeks
Change in tendon thickness on Magnetic Resonance Image (MRI)
Tendon thickness is assessed by an independent evaluator.
Time frame: 24 weeks
Change in tear/footprint on MRI
Ratio of tear lengths to whole footprint length is measured by an independent evaluator.
Time frame: 24 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 weeks
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