RESUMO
A topical medical device, AI500®, constituted of a single-chain polypeptide embedded in hyaluronic acid, was tested and evaluated in patients with reduced knee function due to osteoarthritis and other knee conditions. A total of 35 participants with reduced knee function assessed by the WOMAC Physical Function score were recruited. Four study visits were planned, from the first application at V0 to 1 week follow up at V3. Patient symptomatology was evaluated after 24 h (V1) and after 48 h (V2) through phone contact, and after 1 week from V0, on site (V3). The overall duration of the follow up was one week. An amelioration of 40% in WOMAC Physical Functional scores after 1 week of treatment was recorded, thus achieving the primary endpoint of 20%. Furthermore, a reduction of 29% in Physical Functional scores and of 28% in total WOMAC scores between V0-V2 was registered, together with a decrease of 39% between V0 and V3. The NRS scale showed a 29% and 37% reduction in pain between V0-V1 and V0-V2, respectively. Product safety was confirmed by the very low rate of adverse effects, non-device related, observed in only 2 patients out of 35, resolved spontaneously within 24-48 h. No safety concerns or risks associated with the use of the device were highlighted. There are few the studies on the topical use of HA-based gels for the treatment of knee problems. Compared to invasive intra-articular injections and oral pharmacological therapies used in cases of knee pain, the topical application of AI500® is non-invasive, safe, and appreciated by patients. Good results in terms of functional improvement and symptoms resolution were obtained in less than 1 week.
RESUMO
Once considered a non-fundamental structure, the menisci are now known to provide several functions within the knee, including protection of articular cartilage, load-bearing, shock absorption, joint stability, joint lubrification and joint congruity functions. Meniscal tears are one of the most common lesions in knee orthopedics, and partial or total meniscectomies are commonly performed procedures in orthopedic surgery. Despite meniscectomy is well recognized to lead improvement in clinical outcomes, it has been related to early onset knee osteoarthritis and joint degeneration which are associated with pain and functional limitations. Meniscal allograft transplantation has become a viable option for patients under 55 years old that have undergone total or near total meniscectomy and are in a painful state. This procedure can be performed using bone plugs or without bone plugs. In the bone plugs free technique allograft will be presented as a lateral meniscus with a portion of tibial plateau and is then introduced into the joint through an arthroscopic portal and fixed to the capsule with all-inside stitches. The most important aspect required to obtain good clinical results are graft size, anatomic placement and fixation, because extrusion is the most common complication related to meniscal transplantation. Although a lack of long-term follow-up (FU) studies, it has been demonstrated that lateral meniscus transplantation without bone plugs is a minimal invasive surgical procedure that improves the knee function, increases patient physical activity and reduces pain.
