NCT05275244

Evaluate Clinical Benefit of Local Treatment With KD Intra-Articular® Gel in Patients With Osteoarthritis (NO-DOLOR2)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 67 (actual)
• Sponsor: Procare Health Iberia S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prospective observational, national, multicenter, 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 objective is to evaluate the clinical benefit of local treatment with KD Intra-Articular® gel 2.2% - 44 mg in 2 ml - (Pronolis® HD one 2, 2%), in patients with osteoarthritis of the shoulder or hip and with KD Intra-Articular® gel 1.6% - 16 mg in 1 ml - (Pronolis® HD mini 1.6%) in patients with osteoarthritis of the ankle or base of the thumb. The study comprises a maximum of 6 visits per protocol. At visit 0, informed consent will be obtained, the patient will be checked for compliance with all inclusion criteria and no exclusion criteria in the study, and a medical history and physical examination will be carried out. A pain assessment will also be carried out using a VAS and the corresponding questionnaire will be completed depending on the joint to be treated (WOMAC, FAOS, ASES or DASH) and if it is the base of the thumb, the hand dynamometer test will be performed to obtain baseline results. According to the usual clinical practice of the center, the study treatment will be administered, or you will be summoned for administration at a later visit. A week after the first infiltration (V0) the second will be applied, and the VAS will be repeated (V1). The GCI-C evaluation by the patient and the Likert scale of satisfaction will also be carried out. AEs will be collected, if any, and if there have been changes in concomitant medication. The next visit (V2) will be carried out a week after the second infiltration has been placed 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 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. The study will be conducted under routine clinical practice conditions, with no restrictions being imposed on the participating doctor prescribing the drug(s) and no interference in normal clinical practice. Except for the scales and/or questionnaires used as measurement instruments in this study and a patient diary where the necessary rescue medication will be collected, the patients included will not be given any intervention, either diagnostic or follow-up, that is not the usual practice in clinical practice.

Conditions

• Osteoarthritis, Hip
• Osteoarthritis Thumb
• Osteoarthritis Ankle

Interventions

Type	Name	Description
DEVICE	KD Intra-Articular® gel	Depending on the joint, 3 injections will be administrated to the patient: KD Intra-Articular® gel 2.2% - 44 mg in 2 ml - (Pronolis® HD one 2.2%) in the case of shoulder and hip, or KD Intra-Articular® gel 1.6% - 16 mg in 1 ml - (Pronolis® HD mini 1.6%) in the case of the ankle and base of the thumb. The administration of the infiltrations will be with an interval of one week.

Timeline

• Start date: 2022-03-17
• Primary completion: 2022-09-01
• Completion: 2023-12-14
• First posted: 2022-03-11
• Last updated: 2024-04-03

Locations

1 site across 1 country: Spain