Efficacy of intra-articular polynucleotides in the treatment of knee osteoarthritis: a randomized, double-blind clinical trial

Abstract

This randomized, double-blind clinical trial was conducted over 16 weeks to assess the efficacy and safety profile of intra-articular polynucleotides gel injections in the treatment of knee osteoarthritis associated with persistent knee pain. 60 patients were enrolled and randomized to receive intra-articular polynucleotides (n = 30) or hyaluronan (n = 30); patients received five weekly intra-articular knee injections and the follow-up period was 3 months after the end of treatment. Primary endpoint was to determine polynucleotides (PN) efficacy in reducing knee pain at the end of the study, over baseline value and over standard hyaluronan viscosupplementation (HA). Pain levels were measured using a 0-10 cm Visual Analogue Scale (VAS). Secondary endpoints included Knee Osteoarthritis Outcome Score (KOOS), NSAIDs consumption, crackling during movement and articular mobility limitation. The mean global VAS pain decreased from 5.7 + or - 1.9 cm (T0) to 1.9 + or - 1.5 cm (T16) in polynucleotide group and from 4.9 + or - 2.0 cm (T0) to 2.1 + or - 1.4 cm (T16) in hyaluronan group. The reduction in pain was statistically significant for both groups. KOOS increases from baseline values were statistically significant in both groups. No significant adverse events were reported. These findings suggest that intra-articular polynucleotides can be a valid alternative to traditional hyaluronan supplementation for the treatment of knee osteoarthritis.

Evidence-Based Knee Injections for the Management of Arthritis

“…Intraarticular injection of polynucleotide gel was compared with hyaluronan in 60 patients with OA and both groups achieved statistically significant pain reduction, although no significant difference between the two groups [42] (2B+ Level). Condrotide–Turnover joint is a new product composed of polynucleotides 20 mg/mL that bind water and form a 3‐D gel that can moisturize articular surfaces.…”

Polydeoxyribonucleotides (PDRNs) From Skin to Musculoskeletal Tissue Regeneration via Adenosine A2A Receptor Involvement

“…Studies on musculoskeletal tissue regeneration were conducted on: (1) bone tissue, one in vitro on osteoblasts (OBs) (Guizzardi et al, ), two in vivo in rat bone defects and subcutaneous pockets (Guizzardi et al, ; Kim et al, ) and one in patients affected by ischiofemoral impingement syndrome (IFI) (Kim et al, ); (2) cartilage tissue, one in vitro on cartilage explants (Gennero et al, ), two in patients affected by knee OA (Vanelli et al, ; Giarratana et al, ) and one both in vitro, on chondrocytes from patients affected by rheumatoid arthritis (RA), and in vivo in mice affected by arthritis (CIA) (Bitto et al, ); (3) tendon tissue in patients affected by plantar fasciitis (Kim and Chung, ).…”

“…Contrary to what observed for the regeneration of the skin, it takes several intra‐articular injections of PDRNs (from three to five times) for pain relief and physical function improvement. However, PDRNs seemed to be effective as HA, the gold standard of the infiltrative treatment for OA (Giarratana et al, ) or even better (Vanelli et al, ).…”

“…In conclusion, for the first time this review collects all preclinical and clinical literature studies on the effects of PDRNs in musculoskeletal tissue diseases with the intention to understand the anti‐inflammatory and regenerative mechanisms of PDRNs and to drive other future researches in this field. It is also important to point out that the four clinical studies on musculskeletal tissues (one abut IFI, two on knee OA, and one on plantar fasciitis) were case reports (Kim et al, ) and randomized double‐blind clinical trials with a blind analysis of the results (Vanelli et al, ; Giarratana et al, ; Kim and Chang, 2015). So, apart from the first clinical study on IFI, the other three, abut knee OA and plantar fasciitis, were properly designed.…”

Viscosupplementation with Hyaluronic Acid or Polynucleotides: Results and Hypothesis for Condro-synchronization

“…Literature has also demonstrated the effectiveness of polynucleotides in the treatment of osteoarthritis in comparison to the standard treatment of viscosupplementation with hyaluronic acid with encouraging results [16,17].…”