PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE THE CLINICAL BENEFIT OF LOCAL TREATMENT WITH KD Intra-Articular® GEL (PRONOLIS® HD), IN PATIENTS WITH OSTEOARTHRITIS OF THE SHOULDER, HIP, ANKLE OR BASE OF THE THUMB

Detailed Summary

Prospective observational, national, multicentre, open study with a class III medical device with EC marking. Study to evaluate the clinical benefit of local treatment with KD intra-articular® gel in patients with osteoarthritis of the shoulder, hip, ankle or base of the thumb. The study will be conducted in the Rheumatology Service of Spanish Hospitals under the usual medical conditions, in accordance with routine clinical practice and following the internationally recognised precepts of good clinical practice of ICH and Declaration of Helsinki. The objective is to evaluate the evolution of pain in patients diagnosed with single or preferential symptomatic osteoarthritis of the shoulder or hip treated with KD Intra-Articular® gel 2.2% - 44 mg in 2 ml - (Pronolis® HD one 2.2%), and ankle or base of the thumb treated with KD Intra-Articular® gel 1.6% - 16 mg in 1 ml - (Pronolis® HD mini 1.6%). Eighty patients will be included among about 6 Spanish Sites. The study comprises a maximum of 6 visits per protocol. At visit 0, informed consent will be obtained, the patient will be checked for fulfil the selection criteria. A pain assessment will also be carried out using a Visual Analogue Scale (VAS) and the corresponding questionnaire will be completed depending on the affected joint. According to the usual clinical practice of the site, the study treatment will be administered. A week after the first infiltration the second visit (V1) will be applied, and the VAS will be repeated. The patient's global clinical impression of change will also be assessed, and along with the Likert scale of satisfaction will be collected. The next visit (V2) will be carried out a week after the second infiltration and the procedures will be the same as those of the previous visit (V1). At 4 (V3), 12 (V4) and 24 (V5) weeks after receiving the third infiltration (V2), follow-up visits will be carried out where the assessment procedures will be the same as in visit 0, in addition to the GCI -C, the Likert scale of satisfaction and the collection of potential AEs and changes in concomitant medication. At each visit, the patient will be given a diary, where they will collect the rescue medication they have needed since the previous visit. In the electronic case report form (eCRF), the rescue medication (analgesics and NSAIDs) that you have needed since the previous visit (V0-V2) or in the month prior to the study visit (V3-V6) will be collected.

Study Details

Timeline

Interventions