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

NCT05936762 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-07-10

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Nextrasearch S.r.l.s.

    lead OTHER

Principal Investigators

  • Roberto Buda, Prof · Ospedale Santa Annunziata di Chieti

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2022-08-09
Completion
2022-08-09

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05936762 on ClinicalTrials.gov