Status:
COMPLETED
Evaluate Clinical Benefit of Local Treatment With KD Intra-Articular® Gel in Patients With Osteoarthritis (NO-DOLOR2)
Lead Sponsor:
Procare Health Iberia S.L.
Conditions:
Osteoarthritis, Hip
Osteoarthritis Thumb
Eligibility:
All Genders
18+ years
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- Age equal to or greater than 18 years.
- Patients who come to a control consultation for single or preferential symptomatic osteoarthritis, primary in the case of the hip, shoulder or base of the thumb, or secondary post-traumatic in the case of the ankle.
- Patients who meet the ACR diagnostic criteria for osteoarthritis of the hip and base of the thumb. Patients who meet the AOFAS diagnostic criteria for ankle osteoarthritis and those for shoulder osteoarthritis defined in the literature.
- Patients with pain equal to or greater than 4 on the VAS pain scale.
- Kellgren-Lawrence grade II-III patients in an X-ray performed within 18 months prior to inclusion.
- Patients in whom viscosupplementation is indicated regardless of their inclusion in the study.
- Patients able to read and understand the Patient Information Sheet and sign, if accepted, the Informed Consent Form.
- Patients able, at the discretion of the investigator, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout the study.
Exclusion
- Known hypersensitivity to sodium hyaluronate or other study treatment components.
- Previous trauma or surgical intervention in the affected joint (except in ankle osteoarthritis).
- Participation in any other clinical trial or use of any drug or experimental device, currently or in the 4 weeks prior to inclusion in the study.
- Swelling, exacerbation, or significant effusion in the affected joint.
- Septic and aseptic arthritis.
- Skin disorder or infection at the site of infiltration.
- Patients requiring intra-articular infiltration in two joints.
- Viscosupplementation of the affected joint within 6 months prior to the start of treatment.
- Infiltration of steroids in the affected joint in the 3 months prior to the start of treatment.
- History of autoimmune, microcrystalline rheumatological diseases or connective tissue diseases.
- Coagulation disorders and/or anticoagulant medication that contraindicates infiltration.
- Women who are pregnant, suspected of being pregnant or breastfeeding.
Key Trial Info
Start Date :
March 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT05275244
Start Date
March 17 2022
End Date
December 14 2023
Last Update
April 3 2024
Active Locations (1)
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1
Hospital Del Mar
Barcelona, Spain, 08003