A randomised, double blinded, placebo controlled clinical study (Petrella et al 2009 (to 16 weeks), EULAR 2010 and 2011 (to 2 years)) was conducted studying the effects of RenehaVis™ (blue line) versus a commercially available high molecular weight (HMW) HA product (yellow line), a commercially available low (standard) molecular weight (LMW) HA product (red line) and placebo (physiological saline) (green). This study, conducted in Canada, versus the 2 products considered by Canadian experts to be the 2 most efficacious in that market, showed that patients administered with RenehaVis™ had consistently lower pain scores (by VAS) from treatment start over time both when walking and at rest compared to the other three arms in the study. Specifically this benefit was achieved quicker after initial treatment, was maintained for longer, and required less concomitant pain control medication throughout than the other 3 treatment arms (HMW, LMW and placebo).

RenehaVis™ treated patients also showed the lowest pain score after the 2nd injection, rather than the 3rd, and this was maintained up to 16 weeks in the 2009 study, which also forms the basis for the current prescribing recommendations for RenehaVis™. However, the most recent data from the study (see 2010 and 2011 reports) shows even longer term benefits than that reported below (see 'Studies' and 'Support') and this currently forms the basis of a prescribing information update application.

An innovative and patented product for knee osteoarthritis, RenehaVis™ is the only product that contains 2 Hyaluronic Acids in 1 syringe for a combined sequential injection for enhanced effect.

Chamber 1 contains: Low molecular weight HA – High concentration
Chamber 2 contains: High molecular weight HA – Low concentration

RenehaVis™ offers patients and doctors a more holistic approach to treating the cause and symptoms of knee osteoarthritis: a dual molecular weight and dual concentration hyaluronic acid concept combined in 1 syringe.

Viscosupplementation products should act to help knee OA patients regain a healthy knee physiology. Low molecular weight HA is known to act as a lubricant in the knee whereas high molecular HA is known for its ability to absorb shock experienced by the knee.

Low molecular weight HA has 2 other functions:

• Diffuses through the cartilage to protect the chondrocytes (note: which help create endogenous HA and proteoglycans) which are commonly destroyed in knee OA patients. This is often termed as the CAGING EFFECT.
• Diffuses to the synoviocytes at the synovial membrane to activate them. This results in the generation of endogenous HA. This action is known as the MECHANOSENSITIVE EFFECT.

This is why RenehaVis™ has a higher concentration of low molecular weight HA – to enable these 3 criteria needed in the knee while the high molecular weight HA is at a lower concentration and has 1 key function (shock absorbing).

RenehaVis™ can be re-administered asa complete course to patients after 6 months or as needed as onset of effect is so rapid. Unlike other HA products RenehaVis™ has also been shown to consistently replicate its efficacy in subsequent treatments over the 2 year duration study.

RenehaVis™ is administered via an intra-articular injection into the knee synovial capsule. Care should always be taken to ensure that correct administration into the synovial capsule is obtained to ensure maximum patient comfort and product effect. There are various techniques used to optimally conduct an intra-articular injection.

There were no exceptional or serious adverse events reported during the clinical study. Non-serious adverse events included pain and local swelling at the injection site (21%), erythema at the injection site (12%), and stiffness in the treated knee (7%) amongst all groups.