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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05936762
Other study ID # NeoialHC
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 31, 2021
Est. completion date August 9, 2022

Study information

Verified date June 2023
Source Nextrasearch S.r.l.s.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Osteoarthritis (OA) is one of the most frequent causes of pain and disability in adults. According to the Osteoarthritis Research Society International (OARSI), at least 40% of people over the age of 65 suffer from symptomatic osteoarthritis of the hip or knee. Knee osteoarthritis (OA) is the eleventh leading cause of years lived with disability according to the World Health Organization. The guidelines show that treatment with intra-articular injections of hyaluronic acid (HA) leads to a slow, prolonged pain relief (up to six months after the first injection); On the other hand, there is little evidence in the literature about the intra-articular use of isolated collagen or in combination with hyaluronic acid in the treatment of knee osteoarthritis. The present study showed a clinically good safety profile and provided preliminary evidence of the efficacy of NEOIAL HC for the treatment of symptomatic knee OA


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date August 9, 2022
Est. primary completion date August 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - Age - Knee OA - VAS > 3 - Kellegren radiographic stage 3-4 Exclusion Criteria: - presence of joint effusion, - VAS score <3 according to the American College of Rheumatology Criteria - neoplasms, - haematological diseases, - specific rheumatological pathologies, - bleeding disorders, local infections, - refusal or non-compliance of the patient, - candidacy for knee joint replacement or any intra-articular injection during the previous year, - addiction to opioid drugs, - recent heart attack or stroke.

Study Design


Intervention

Device:
Neoial HC
Patients with severe knee osteoarthritis were enrolled in the clinical study and treated with 3 injections of 40 mg NEOIAL HC (HA sodium salt at 2% with two molecular weights 20% with pm at 400 kD and 80% between 1200 and 1500 kD t + collagen) at a distance of 1 week from each other, followed by a fourth infiltration of the same product at a distance of 1 month from the third.Patients were followed up with baseline clinical evaluation, reporting of adverse events after each single infiltration and subsequently at the end of treatment, 3, 6 months follow-up.

Locations

Country Name City State
Italy Ospedale SS Annunziata Chieti

Sponsors (1)

Lead Sponsor Collaborator
Nextrasearch S.r.l.s.

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other occurrence of AEs and serious adverse events (SAEs) reported on patients' open questionnaires, related or not to the product or procedures, abnormal laboratory results in terms of hematology, serum chemistry, and coagulation parameters, and clinically relevant findings at physical examination (including vital signs) during the entire study duration through study completion, an average of 1 year
Primary VAS score The primary objective in the study was to evaluate the mean changes from baseline at Month 3 in VAS Pain Subscale Score 6 months
Secondary Knee Injury and Osteoarthritis Outcome Score (KOOS) The KOOS is self-administered and assesses 5 domains: pain, symptoms, activities of daily living (ADL), sport and recreation function, and knee-related quality of life. This scale is used to evaluate knee function in terms of activities of daily living (ADL). 6 months
Secondary Lequesne measure the severity for osteoarthritis for the knee (ISK). This can be used to assess the effectiveness of therapeutic interventions 6 months
Secondary Western Ontario McMaster Universities (WOMAC®) VA3.1 self-administered, patient-centered health status questionnaires allowing a thorough evaluation of pain, stiffness, and knee function (24 questions through three subscales) 6 months
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