A RANDOMIZED CONTROLLED TRIAL OF AUTOLOGOUS TENOCYTE INJECTION VERSUS CORTICOSTEROID INJECTION FOR SYMPTOMATIC PARTIAL THICKNESS ROTATOR CUFF TEARS

Abstract

BACKGROUND Symptomatic supraspinatus tears are difficult to treat, causing persistent subacromial impingement symptoms. Clinical studies of Autologous Tenocyte Injection (ATI) have shown that cultured tenocytes can synthesize extracellular matrix and facilitate healing of damaged tendon tissue. This randomized controlled trial (RCT) investigated the efficacy of ATI compared to corticosteroid injection (CS), combined with a graded rehabilitation program, in patients with symptomatic tendinopathy and partial thickness cuff tears. METHODS Eligible participants with a duration of symptoms >6 months were recruited and randomized to receive ATI to the interstitial tear or CS to the subacromial bursa in a 2:1 ratio, under ultrasound guidance, followed by a rehabilitation protocol. Assessments were undertaken pre-treatment and at 1, 3, 6 and 12 months post-treatment, including the Constant Score, Visual Analogue Pain Scale (VAS) and American Shoulder and Elbow Surgeons Assessment (ASES). Magnetic resonance imaging (MRI) was performed at baseline, 6 and 12 months. RESULTS Thirty participants were enrolled (ATI=19, CS=11). The ATI group performed significantly better in the Constant Score at 1 (p=0.020, ATI=81.8, CS=67.6), 6 (p=0.026, ATI=84.9, CS=71.1) and 12 (p=0.024, ATI=86.5, CS=65.4) months, reported better (p<0.05) VAS scores at all post-treatment timepoints and reported better ASES scores at all timepoints including 6 (p=0.012, ATI=88.6, CS=74.0) and 12 (p<0.01, ATI=93.3, CS=62.9) months. A total of 7 of 11 CS participants withdrew from the trial between 6 and 12 months due to worsening pain. These patients were subsequently offered and underwent ATI, with 6 and 12 month improvements similar to the primary ATI group. CONCLUSION ATI resulted in a significantly better and sustained reduction in pain, and improvement in shoulder function, compared with CS. This is the first Level 1 study using ATI to treat supraspinatus tears.