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

Phase 4

Completed

• Conditions: Osteoarthritis of Knee
• Interventions: Device: Neoial HC

• Registration Number: NCT05936762
• Lead Sponsor: Nextrasearch S.r.l.s.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-31
• Primary Completion: 2022-08-09
• Study Completion: 2022-08-09
• Status Verified: 2023-06
• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-29
• Last Update Submitted: 2023-06-29
• Study First Posted: 2023-07-10
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoial	Neoial HC	Treatment with the MD

Primary Outcome Measures

Name	Time	Method
VAS score	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 Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS)	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).
Western Ontario McMaster Universities (WOMAC®) VA3.1	6 months	self-administered, patient-centered health status questionnaires allowing a thorough evaluation of pain, stiffness, and knee function (24 questions through three subscales)
Lequesne	6 months	measure the severity for osteoarthritis for the knee (ISK). This can be used to assess the effectiveness of therapeutic interventions

Trial Locations

Locations (1)

Ospedale SS Annunziata; 🇮🇹 Chieti, Italy