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

Osteoarthritis of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05936762
• Other study ID #: NeoialHC
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Knee
• Osteoarthritis, Knee

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