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

NCT05936762 | Completed Phase 4

• 1 other identifier: NeoialHC
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Osteoarthritis of Knee

Keywords

Osteoarthritis; knee; hyaluronic; collagen; neoial; gonarthrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  6 months

• Lequesne

  6 months

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

  6 months

Other Outcomes (1)

• occurrence of AEs and serious adverse events (SAEs)

  through study completion, an average of 1 year

Study Arms (1)

Neoial

EXPERIMENTAL

Treatment with the MD

Device: Neoial HC

Interventions

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.

Neoial

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• Knee OA
• VAS \> 3
• Kellegren radiographic stage 3-4

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nextrasearch S.r.l.s.: lead

Study Sites (1)

Ospedale SS Annunziata

Chieti, 66100, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Roberto Buda, Prof

  Ospedale Santa Annunziata di Chieti

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Of the 36 screened patients, 15 had to be included and treated patients (15 as planned per-protocol). Of these, 14 patients completed the study and attended the visit at Month 6 . Since all patients were treated , the Full Analysis Set (FAS, all randomized and treated patients) was identical to the Safety Set (all treated patients). The mean age at enrollment was 71±7 years (range 54-80;median 73), and 12 of patients were women (85.7%) and 2 male (14.3%) . The mean BMI were26.6±3.4 (range 21-30;median 28.5) . Overall patients had knee OA with a Kellgren-Lawrence grade II and III (50/50).

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 10, 2023
• Study Start: August 31, 2021
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: July 10, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)