First clinical experience with a new injectable recombinant human collagen scaffold combined with autologous platelet-rich plasma for the treatment of lateral epicondylar tendinopathy (tennis elbow)

Abstract

Background: Lateral epicondylitis is a tendinopathy of the common extensor origin at the elbow. When traditional conservative treatment fails, more effective therapies are needed. Vergenix Soft Tissue Repair (STR) Matrix (CollPlant Ltd., Ness-Ziona, Israel) is an injectable gel composed of cross-linked bioengineered recombinant human type I collagen combined with autologous platelet-rich plasma (STR/PRP). The complex forms a collagen-fibrin matrix that 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 hypothesized that STR/PRP would be 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 after treatment.

Results: The study enrolled 40 patients. No systemic or local severe adverse events were reported. Clinical evaluation revealed an improvement in the mean Patient-Rated Tennis Elbow Evaluation score from 64.8 before treatment and showed a 59% reduction at 6 months. The 12-Item Short-Form Health Survey questionnaire showed improvement from a mean score of 30.7 to 37.7 at the final follow-up. Grip strength increased from 28.8 kg at baseline to 36.8 kg at 6 months. Improvements in sonographic tendon appearance were evident among 68% of patients.

Conclusion: 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.

Keywords: Elbow; lateral epicondylitis; recombinant human type I collagen; rhCOL1; tendinopathy; tennis elbow.