Efficacy and Safety Profile of Intra-Articular Administration of Jointex? in Patients Suffering from Symptomatic Hip Osteoarthritis: An Open, Prospective Study with a 12-Month Follow-up:

摘要

Hip osteoarthritis represents a statistically relevant problem in clinical practice; previous reports showed different efficacy and safety profiles for intra-articular use of hyaluronic acid in hip osteoarthritis-affected patients, and in this sense, to add evidence to this topic, data regarding safety and efficacy of ultrasound-guided viscosupplementation are reported in order to establish whether such a therapeutic tool may represent a valid option. This study investigates the safety and efficacy profiles of ultrasound-guided intra-articular injections of Jointex? in hip osteoarthritis affected patients. This is a prospective multicentric study carried out in public hospitals. Adult outpatients suffering from symptomatic hip OA (Kellgren and Lawrence Grade 2, 3 or 4) were injected with one syringe of 4 ml (2 vials) of Jointex? under ultrasound guidance, repeated after six months; when clinically necessary an adjunctive injection was performed. Patients' characteristics, such as gender, age, weight, height and BMI, smoking habit, unilateral or bilateral hip OA, radiological grade for hip OA following Kellgren-Lawrence grading and duration of disease, were evaluated. Patients were assessed at baseline and at every control visit and injection time for Lequesne index as primary endpoint, pain (evaluated by VAS) and NSAID consumption (number of days patients assumed NSAID in the last month) both as secondary endpoint. A total of 180 patients entered the study, all of whom received at least one IA US-guided injection of Jointex? into the hip joint. A total of 36 drop outs were registered, and both distribution and causes of drop out were recorded. A total of 389 injections were carried out, as 18 patients were affected by bilateral hip OA and 7 patients affected by monolateral hip OA required one more injection for symptomatic relief in respect to other patients. Scores obtained for primary as well as secondary study endpoints reached statistical significance when compared with scores obtained at baseline visit. Lequesne index mean scores obtained at each control visit, when compared with baseline mean value, were significantly different (p0.001 for all control visits vs baseline). Similarly, results obtained for secondary endpoints, such as Pain VAS and NSAID consumption, when compared with results obtained at the baseline visit, showed a statistical significance (p0.001 for all control visits vs baseline). We also evaluated how many patients reached an improvement in Lequesne algo-functional index of at least 70% at 6- and 12-month control visits: a percentage of 21.23% of patients attending the 6-month control visit showed such improvement, while at the 12-month control the percentage was 20%. No local or systemic infectious adverse events were reported during the whole follow-up time. Twenty-seven patients out of 180 reported a transient discomfort in the treated hip for 1–3 days after injection that regressed spontaneously or with paracetamol 1 g two or three times a day. No systemic adverse events were observed. Intra-articular administration of Jointex? in hip OA-affected patients seems to be an efficacious and safe therapeutic option.