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Objective: Pronolis® HD Mono 2.5% (4.8 mL) is a sterile viscoelastic solution of Hyaluronic Acid (HA) that has been recently commercialized (medical device class III). It contains the highest concentration of HA (2.5%: 120 mg HA in 4.8 mL) and is currently available in Spain for intraarticular injection in the knee.
The main objective of the study is to evaluate the evolution of pain in patients diagnosed with primary knee osteoarthritis treated with Pronolis® HD Mono 2.5% (4.8 mL).
Methods: An observational, real-life, multicentric (60 specialized care centers), prospective, open study planned to include 300 patients diagnosed with primary knee osteoarthritis (according to ACR criteria, pain at inclusion equal or superior to 4 out of 10) in order to evaluate the pain evolution, measured by the Visual Analogue Scale (VAS).
After a single dose of Pronolis® HD Mono 2.5% (4.8 mL), patients are followed for 6 months. Preliminary results are presented to observe the first trends of change, 3 months vs. basal:
- In the pain domain score of the WOMAC-A questionnaire (main criteria).
- In the score of the domain of joint stiffness, functional capacity and pain in movement (WOMAC-B and C and 1st question of WOMAC-A) (secondary criteria).
- In the evolution of the quality of life measured by the international standardized health questionnaire EQ-5D-5L.
The study is approved by the Ethics Committee for Clinical Research of the Hospital del Mar in Barcelona (CEIC-Parc de Salut Mar).
Results: Currently, 3 months data of 14 patients is available out of the 24 patients included to date.
The degree of pain assessed by the Western Ontario and McMaster Universities Arthritis Index (WOMAC-A) shows an average improvement in pain of 7.71 points (54.5%). In 11 (78.6%) of the 14 patients, the average degree of pain improvement is equal to or greater than 30%.
The degree of stiffness in the joint, the functional capacity of the patient and the degree of pain in movement show an average improvement of 3.71 points (62.87%), of 30.64 points (58.08%) and of 1, 71 points (55.95%), respectively.
Quality of life improves in the 5 dimensions of the EQ-5D-5L improvement of quality of life has measured 34.52% in mobility, 41.67% in personal care, 39.88% in daily activities, 45.83% in pain/discomfort and 61.90% in anxiety/depression.
No patient has presented adverse reactions to the investigational product.
Conclusion: After 3 months of the intra-articular injection of a mono-shot, high-density HA gel (Pronolis® HD Mono- Shot 2.5%) patients with primary knee osteoarthritis show an important tendency to improve pain, joint stiffness, functional capacity and quality of life. These preliminary results need to be confirmed upon study completion.