Arthroscopy, sports medicine, and rehabilitation · 2026
Intratendinous Porcine-Derived Type I Collagen Injections Result in Clinical and Radiographic Improvement of Rotator Cuff Tendinopathy 1 Year After Treatment.
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Randelli Pietro Simone, Muzio Antonio, Stoppani Carlo, Fossati Chiara, Gallazzi Mauro Battista, Menon Alessandra
Аннотация
PURPOSE: To evaluate the clinical and radiological effectiveness of porcine-derived type I collagen injections in patients with symptomatic rotator cuff tendinopathy.
METHODS: In this monocentric pilot study conducted between 2022 and 2025, adults with clinically and radiologically confirmed rotator cuff tendinopathy received 3 ultrasound-guided intratendinous injections at 2-week intervals and were followed for 12 months. A power analysis determined that 24 patients were required to detect a 13-point improvement in the Constant-Murley Score (CMS) at 3 months. The primary outcome was the achievement of a ≥13-point increase in the CMS at 3 months. Secondary outcomes included functional scores, pain intensity, magnetic resonance imaging findings, and analgesic consumption.
RESULTS: Twenty-four patients were enrolled, and 22 completed 12-month follow-up. At 3 months, 8 out of 23 patients (35%) achieved the predefined 13-point CMS as minimal clinically important difference. Mean CMS improved from 62.4 at baseline to 72.2 at 3 months and 78.7 at 12 months (P < .001). The American Shoulder and Elbow Surgeons score improved from 47.3 at baseline to 68.5 at 3 months and 82.2 at 12 months. The Simple Shoulder Test improved from 8.8 to 9.7 at 3 months and 11.3 at 12 months. Pain scores decreased from 5.8 at baseline to 3.5 at 3 months and 2.1 at 12 months. Magnetic resonance imaging at 12 months showed improved tendon quality in 7 out of 20 evaluated patients (35%).
CONCLUSIONS: Intratendinous porcine-derived type I collagen injections were associated with progressive improvements in shoulder function and pain over 12 months in this single-arm pilot study. Although the predefined minimal clinically important difference at 3 months was reached by a proportion of patients, functional scores showed continued improvement throughout follow-up. Magnetic resonance imaging findings showed improved tendon quality in part of the cohort, and no serious adverse events were recorded.
LEVEL OF EVIDENCE: Level IV, prospective therapeutic case series.
METHODS: In this monocentric pilot study conducted between 2022 and 2025, adults with clinically and radiologically confirmed rotator cuff tendinopathy received 3 ultrasound-guided intratendinous injections at 2-week intervals and were followed for 12 months. A power analysis determined that 24 patients were required to detect a 13-point improvement in the Constant-Murley Score (CMS) at 3 months. The primary outcome was the achievement of a ≥13-point increase in the CMS at 3 months. Secondary outcomes included functional scores, pain intensity, magnetic resonance imaging findings, and analgesic consumption.
RESULTS: Twenty-four patients were enrolled, and 22 completed 12-month follow-up. At 3 months, 8 out of 23 patients (35%) achieved the predefined 13-point CMS as minimal clinically important difference. Mean CMS improved from 62.4 at baseline to 72.2 at 3 months and 78.7 at 12 months (P < .001). The American Shoulder and Elbow Surgeons score improved from 47.3 at baseline to 68.5 at 3 months and 82.2 at 12 months. The Simple Shoulder Test improved from 8.8 to 9.7 at 3 months and 11.3 at 12 months. Pain scores decreased from 5.8 at baseline to 3.5 at 3 months and 2.1 at 12 months. Magnetic resonance imaging at 12 months showed improved tendon quality in 7 out of 20 evaluated patients (35%).
CONCLUSIONS: Intratendinous porcine-derived type I collagen injections were associated with progressive improvements in shoulder function and pain over 12 months in this single-arm pilot study. Although the predefined minimal clinically important difference at 3 months was reached by a proportion of patients, functional scores showed continued improvement throughout follow-up. Magnetic resonance imaging findings showed improved tendon quality in part of the cohort, and no serious adverse events were recorded.
LEVEL OF EVIDENCE: Level IV, prospective therapeutic case series.