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Completed

NCT Number: NCT05936762

Clinical Efficacy and Safety of NEOIAL HC for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis

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

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Key information

Conditions

Osteoarthritis of Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale SS Annunziata

Chieti, 66100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neoial HC

Device

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.

Primary outcomes

  1. VAS score

    Time frame: 6 months

    The primary objective in the study was to evaluate the mean changes from baseline at Month 3 in VAS Pain Subscale Score

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 6 months

    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).

  2. Lequesne

    Time frame: 6 months

    measure the severity for osteoarthritis for the knee (ISK). This can be used to assess the effectiveness of therapeutic interventions

  3. Western Ontario McMaster Universities (WOMAC®) VA3.1

    Time frame: 6 months

    self-administered, patient-centered health status questionnaires allowing a thorough evaluation of pain, stiffness, and knee function (24 questions through three subscales)

Other outcomes

  1. occurrence of AEs and serious adverse events (SAEs)

    Time frame: through study completion, an average of 1 year

    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

Sponsors and collaborators

Lead sponsor

Nextrasearch S.r.l.s.

Other

Registry information

Official study title

Clinical Efficacy and Safety of NEOIAL HC (Hyaluronic Acid + Collagen) for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 10, 2023
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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