Status:
UNKNOWN
Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients With Osteoarthritis of the Knee
Lead Sponsor:
Tedec-Meiji Farma, S.A.
Collaborating Sponsors:
Alpha Bioresearch S.L.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
A Phase III, prospective, multicentre, non-controlled, with consecutive participant enrollment in order to evaluate the efficacy, safety and duration of the effects of the viscosupplementation with a ...
Detailed Description
Prospective, multicentre and non-controlled study. Each patient will receive a single injection of SH 2% and will be followed for 1 year with follow up visits at 6 and 12 months At 6 months follow up ...
Eligibility Criteria
Inclusion
- Patient ≥ 45 years of age of either sex.
- Primary knee OA of the medial or lateral femoro-tibial compartment documented according to ACR criteria with symptoms, at screening, from at least 3 months.
- KL radiological grade 2-3.
- Antero-posterior view X-Ray image of the target knee
- Pain intensity at screening in the target knee ≥40 mm and \<80 mm measured by Visual Analogue Scale (VAS), and ≤ 20 mm in the contralateral knee.
- Able to understand and willing to comply with study procedures.
- Able to provide informed consent.
Exclusion
- BMI ≥ 30 kg/m2.
- Pregnant or lactating women. Women of child-bearing age not using effective contraception.
- Severe inflammation of the target knee.
- Previous surgery in the target knee, including arthroscopy.
- Subjects with any musculoskeletal condition affecting the target knee that would impair the proper evaluation
- Patients with joint inflammatory disease, microcrystalline arthropathies and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment.
- Underlying disease considered by the investigator that might interfere with the development and evaluation study.
- Subjects with venous or lymphatic stasis in the relevant limb.
- Previous administration of any of the following treatments: hyaluronic acid i.a. (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study.
- Pain in other parts of the body greater than the knee pain that could interfere with the evaluation.
- Any pathology that, under investigator judgement, interfere with the administration or assessment.
- Patients with known hypersensitivity to SH or paracetamol.
- Patients in waiting list for surgery.
- Patients awaiting disablement assessment.
- Previous participation in this protocol
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03852914
Start Date
January 17 2019
End Date
April 1 2020
Last Update
March 1 2019
Active Locations (10)
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1
Hospital General de Elche
Elche, Alicánte, Spain, 03203
2
Hospital de la Marina Baixa de Villajoyosa
Villajoyosa, Alicánte, Spain, 03570
3
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
4
Complejo Hospitalario La Coruña
A Coruña, Spain, 15006