Intra-articular Administration of Med Device Made of Biological Vegetal Matrix for the Treatment of Knee Osteoarthritis

NCT05925595 | Completed

• 1 other identifier: NBM-KOA 05/21
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

A pre-market randomized, parallel group, single-blind, clinical study with a Medical Device, made of vegetal material, to evaluate the efficacy and safety of one knee injection of the investigational device versus active comparator (Jonexa). The study population will consist of 150 patients diagnosed with primary knee osteoarthrosis. At present, the study is monocentric competitive. Treatment period for each patient is 6 months.

Conditions

the Treatment of Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change at 2 weeks from baseline in WOMAC Pain

  To the patient will be asked to answer 5 questions about the pain experienced in the previous 48 hours, during different activities, using a 5-point Likert scale (0 to 4) for each answer. The total score (minimum 0; maximum 20) is given by the sum of the 5 answers given.

  [Time Frame: 14 days]

Secondary Outcomes (4)

• Change from baseline in WOMAC function

  Time Frame: 14 days

• Change in WOMAC pain and function at 4, 12, 24 weeks from baseline

  Time Frame: baseline, 4, 12, 24 weeks

• Change in SF-36 at 4, 12, 24 weeks from baseline

  Time Frame: baseline, 4, 12, 24 weeks

• Adequate global relief of symptoms after treatment

  Time Frame: 2, 4, 12, 24 weeks

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Arm: Medical Device Iniettabile Ginocchio

Device: Medical Device Iniettabile Ginocchio

Comparator Arm

ACTIVE COMPARATOR

Arm: Medical Device Jonexa (active comparator medical device from the market )

Device: Medical Device Iniettabile Ginocchio

Interventions

Medical Device Iniettabile Ginocchio DEVICE

Knee injection of the investigational device( MD Iniettabile Ginocchio) versus active comparator (Jonexa).

Comparator Arm; Experimental Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Patient of both sexes over 40 years of age
• Diagnosis of primary osteoarthritis of the knee according to the criteria of the American College, radiologically confirmed, i.e., one or more osteophytes and a measurable joint space on a standard radiograph taken within 3 months prior to screening.
• Score ≥2 in the target knee on a Likert scale at WOMAC pain question 1 (i.e. pain while walking on a flat surface) at the V-1 screening visit (to be confirmed at the V0 baseline visit). The target knee is defined as the knee with osteoarthritis in the case of unilateral pathology or the only one with this criterion in the case of bilateral pathology.
• Severity grade of arthrosis 2 or 3 according to Kellgren \& Lawrence classification.
• Be willing to maintain stable eating habits and lifestyle throughout the study period

You may not qualify if:

• Intake of analgesics, NSAIDs or opioids within 5 days prior to the start of the run-in (i.e. prior to V-1).
• Body Mass Index (BMI) ≥ 30 kg/m2 .
• Pregnant women.
• Intra-articular visco supplementation in the target knee in the preceding 9 months.
• Cycle of treatment with systemic corticosteroids or intra-articular corticosteroid injection in any joint in the 3 months prior to screening.
• Symptomatic arthrosis of the contralateral knee with a score ≥3 on a Likert scale to WOMAC pain question 1 (pain while walking on a flat surface) at V-1 (to be confirmed at V0), or severe symptomatic hip arthrosis.
• Significant deformity: genu varum, ligament laxity or meniscus instability.
• Presence of autoimmune diseases (excluding chronic autoimmune thyroiditis) or other chronic inflammatory processes (e.g. rheumatoid arthritis, ongoing infections, gout).
• Ongoing infections.
• Established or presumed allergy to hyaluronic acid, echinacea or centella.
• Patients with malignant neoplasms of any kind, or with a history of malignant neoplasms except for patients with a positive history of a malignant neoplasm that has been surgically removed and has not recurred within five years prior to study participation.
• Abuse of alcohol, narcotics or psychotropic drugs that can alter the state of vigilance and physical perception.
• Dementia of any kind or other possible causes of progressive deterioration of the mental soundness, or any psychological or physical disability that reduces the ability to take the treatment under study as intended.
• Inadequate reliability or presence of conditions that may lead to non- compliance/adherence of the patient to the protocol.
• Previous participation in a clinical study within the last 30 days.

Sponsors & Collaborators

• Bios-Therapy, Physiological Systems for Health S.p.A: lead
• Iqvia Pty Ltd: collaborator

Study Sites (1)

Azienda Ospedaliera di Perugia

Perugia, Perugia, 06156, Italy

Location

Study Officials

• Auro Caraffa, MD

  Azienda Ospedaliera di Perugia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded (participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: June 29, 2023
• Study Start: December 6, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: April 17, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)