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Monovisc for Knee Osteoarthritis
Monovisc is a single injection viscosupplement used to treat knee joints affected by osteoarthritis. It is an intra-articular injection, meaning it is injected into the affected joint. Monovisc was developed by Anika Therapeutics, Inc. and received marketing approval from the Food and Drug Administration on February 25, 2014. Monovisc is marketed by DePuy Synthes, Mitek Sports Medicine under a license agreement with Anika.
The hyaluronan (a complex sugar of the glycosaminoglycan family) in Monovisc is a high molecular weight, ultra-pure derivative of natural hyaluronan from a non-animal source. The hyaluronan is derived from bacterial cells and is cross-linked with a proprietary solution. Monovisc delivers a comparable dose to Orthovisc, another Anika Therapeutics viscosupplement, but Orthovisc is administered in a series of three injections rather than a single injection.
Monovisc is indicated for the treatment of knee osteoarthritis in patients who have failed conservative treatments, such as non-drug treatments and non-narcotic pain medications (e.g., acetaminophen). The primary characteristic of knee osteoarthritis is cartilage damage which causes considerable pain and limited range of motion in the affected joint. In osteoarthritis, there are abnormalities with the synovial fluid as well. Synovial fluid lubricates the joint normally, allowing for friction-free movement. Viscosupplements, such as Monovisc and others that were previously approved, return viscous, lubricating properties to the joint.
It's important to note the American College of Rheumatology and the Arthritis Foundation conditionally recommend against viscosupplementation for knee arthritis and for arthritis of the carpometacarpal (CMC) joint (where the base of the thumb meets the hand), and strongly recommend against such injections for hip arthritis.
Safety and effectiveness data from a randomized, controlled, double-blind clinical study involving 369 study participants with knee osteoarthritis at 31 centers in the U.S. and Canada was the basis for the FDA approval of Monovisc, according to Anika Therapeutics. The participants were randomly assigned Monovisc or saline injections (the control). They were evaluated for improvement in joint pain using WOMAC (the Western Ontario and McMaster Universities Osteoarthritis Index), specifically looking for Monovisc patients who achieved a greater improvement in their WOMAC score compared to control patients over a 12-week period. The safety portion of the analysis revealed an "extremely low rate of adverse events" and no serious adverse events with Monovisc.
The first viscosupplement was approved in 1997. There are now five other viscosupplements, most of which require a series of injections rather than a single injection.
- Synvisc and Synvisc-One (single injection made from chicken combs)
Effectiveness of viscosupplementation
In 2012, a report published in the Annals of Internal Medicine concluded that viscosupplementation was ineffective and risky. The report stated that viscosupplementation produces an irrelevant reduction in pain while potentially increasing the risk of flare-ups and adverse events. This conclusion was based on a meta-analysis of 89 randomized trials involving more than 12,000 knee osteoarthritis patients.
The American Academy of Orthopedic Surgeons, however, states that "Viscosupplementation can be helpful for people whose arthritis has not responded to basic treatments. It is most effective if the arthritis is in its early stages (mild to moderate). Some patients may feel pain at the injection site, and occasionally the injections result in increased swelling. It may take several weeks to notice an improvement after viscosupplementation. Not all patients will have relief of pain. If the injections are effective they may be repeated after a period of time, usually 6 months. The long-term effectiveness of viscosupplementation is not yet known and research continues in this area. "
Anika Therapeutics. FDA Approves Monovisc, A New Single Injection Treatment for Treatment of Pain Due to Osteoarthritis of the Knee. Feb 25, 2014.
Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American college of rheumatology / arthritis foundation guideline for the management of osteoarthritis of the hand, hip, and knee.Arthritis Care & Research. Feb 2020; 72 (2): 149-162. doi: 10.10002 / acr.24131
Rutjes AW, Jüni P, Da costa BR, et al. Viscosupplementation for osteoarthritis of the knee: a systematic review and meta-analysis. Ann Intern Med. 2012; 157 (3): 180-91. doi: 10.7326 / 0003-4819-157-3-201208070-00473
American Academy of Orthopedic Surgeons, Viscosupplementation Treatment for Arthritis. April 2013.
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