Article
First Clinical Experience with a Novel Injectable rhCollagen Scaffold Combined with Autologous Platelet-Rich Plasma for the Treatment of Lateral Epicondylar Tendinopathy (Tennis Elbow)
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Published: | February 6, 2020 |
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Objectives/Interrogation: Lateral epicondylitis is a tendinopathy of the common extensor origin at the elbow. When traditional conservative treatment fails, more effective therapies are needed. VergenixTM Soft Tissue Repair Matrix is an injectable gel composed of cross-linked bio-engineered recombinant human type I collagen combined with autologous platelet-rich plasma (STR/PRP). The complex forms a collagen-fibrin matrix, which promotes cell migration and tissue repair. Based on positive outcomes from preclinical trials, this study is the first clinical trial of STR/PRP on tendinopathy. We hypothesize that STR/PRP is a safe and effective treatment for lateral epicondylar tendinopathy.
Methods: Patients with chronic lateral epicondylitis underwent treatment with STR/PRP. Outcome assessment included grip strength, functional disability and changes in sonographic tendon appearance for up to 6 months following treatment.
Results and Conclusions: Forty patients were enrolled in the study. No systemic or local severe adverse events were reported. Clinical evaluation revealed an improvement in mean PRTEE score from 64.8 prior to treatment, and showed a 59% reduction at 6 months. The SF-12 questionnaire showed improvement from a mean score of 30.7 to 37.7 at the final follow up. Grip strength rose from 28.8 Kg at baseline to 36.8 Kg at 6 months. Improvements in sonographic tendon appearance were evident among 68% of patients.
We conclude that STR/PRP is a safe treatment that effectively induces clinically significant improvements in elbow symptoms and general well-being as well as objective measures of strength and imaging of the common extensor tendon within 6 months of treatment of elbow tendinopathy recalcitrant to standard treatments.