Comparative evaluation of the performance and safety of A-CP HA Kit, for the preparation of a combination of platelet-rich plasma and hyaluronic acid, versus hyaluronic acid alone and placebo in patients with knee osteoarthritis

  • STATUS
    Recruiting
Updated on 11 June 2020
knee pain
hyaluronic acid

Summary

The purpose of this study is to assess the performance and safety of a combination of hyaluronic (HA) and platelet-rich plasma (PRP) in knee injection treatment for use in relieving symptoms in patietns with knee pain.

To qualify you must be between ages 50 and 80, have Grade 2 or 3 Osteoarthritis, and have had a previous Hyaluronic acid injection.

 

Details
Condition Osteoarthritis
Clinical Study IdentifierTX234364
Last Modified on11 June 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 50 yrs and 80 yrs?
Gender: Male or Female
Do you have Osteoarthritis?
Osteoarthritis grade 2-3 according to the Kellgren & Lawrence grading scale, as defined on knee radiographs (less than 3 months old: face view, schuss view, profile and patellar axial view at 30°)
Knee Pain level of at least 5 on the 0-10-point WOMAC A subscale
Bilateral osteoarthritis provided that the contralateral knee has a pain no more than 3 on the 0-10 point scale, and not requiring systemic analgesic treatment except paracetamol until the maximum dose of 4g per day

Exclusion Criteria

Grade <2 or >3 OA according to the Kellgren and Lawrence grading scale
Bilateral osteoarthritis provided that the contralateral knee has a pain more than 3 on the 0-10 point scale and requiring systemic analgesic treatment or paracetamol more than 4g per day
Viscosupplementation in the treatment site in the past 3 months
Corticosteroid injection in the treatment site in the previous 3 months
Systematic use of corticosteroid (except those that are inhaled) within 3 months
History of allergy to hyaluronic acid
Rheumatological disorders
Clinical evidence of local inflammation such as redness or heat of the joint
Current or medical history of autoimmune disease
Surgery or arthroscopy surgery in the affected knee in the past 3 months
Local infection in the affected knee
Hematologic or clotting disorders (thrombocytopenia) or blood coagulation (deficit-blood dyscrasia)
Anaemia (Haemoglobin < 10g/dl)
Platelet count below 150/mmc
Anticoagulant treatment
Viral disease (hepatitis, herpes, varicella, zona, etc.)
Renal failure or hemodialysis
Acute infection
Immunosuppressive states
Malignant disease
Recent fever (within previous 2 weeks) or serious disorders (liver disease, active gastroduodenal ulcer, digestive hemorrhage, etc.)
Pregnancy or breastfeeding or planning pregnancy during the course of the study
Immunosuppressants within the past 6 weeks or ongoing
Uncontrolled diabetes
Participation in another clinical study in the past 3 months
Ongoing participation in another OA clinical study
Fracture, skeletal dysplasia, congenital or acquired deformity that affects the knee
Hemoglobin A1C > 8% within 8 weeks prior to the study treatment
Have been given the diagnosis of fibromyalagia, neuropathic pain syndrome, or depression
Refusal to sign or inability to give Informed Consent
Inability to understand or comply with the requirements of the study
Any other reason which may interfere with the proper conduct of the study, in the investigator's opinion
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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