Intra-articular Administration of Med Device Made of Biological Vegetal Matrix for the Treatment of Knee Osteoarthritis
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ClinicalTrials.gov Identifier: NCT05925595 |
Recruitment Status :
Recruiting
First Posted : June 29, 2023
Last Update Posted : July 3, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
the Treatment of Knee Osteoarthritis | Device: Medical Device Iniettabile Ginocchio | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel Assignment |
Masking: | Single (Participant) |
Masking Description: | Single blinded (participant) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Parallel Group, Single Blind Clinical Trial Against Active Comparator to Evaluate the Efficacy and Safety of a Medical Device Made of a Vegetal Biological Matrix for the Treatment of Knee Osteoarthritis. |
Actual Study Start Date : | December 6, 2022 |
Estimated Primary Completion Date : | March 1, 2024 |
Estimated Study Completion Date : | December 1, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Experimental Arm
Arm: Medical Device Iniettabile Ginocchio
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Device: Medical Device Iniettabile Ginocchio
Knee injection of the investigational device( MD Iniettabile Ginocchio) versus active comparator (Jonexa). |
Active Comparator: Comparator Arm
Arm: Medical Device Jonexa (active comparator medical device from the market )
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Device: Medical Device Iniettabile Ginocchio
Knee injection of the investigational device( MD Iniettabile Ginocchio) versus active comparator (Jonexa). |
- Change at 2 weeks from baseline in WOMAC Pain [ Time Frame: [Time Frame: 14 days] ]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.
- Change from baseline in WOMAC function [ Time Frame: Time Frame: 14 days ]To the patient will be asked to answer 16 questions about the function in the previous 48 hours, during different activities, using a 5-point Likert scale (0 to 4) for each answer. The total score
- Change in WOMAC pain and function at 4, 12, 24 weeks from baseline [ Time Frame: Time Frame: baseline, 4, 12, 24 weeks ]To the patient will be asked to answer " WOMAC pain and function" questions about the function in the previous 48 hours, during different activities, using a 5-point Likert scale at 4, 12, 24 weeks from baseline
- Change in SF-36 at 4, 12, 24 weeks from baseline [ Time Frame: Time Frame: baseline, 4, 12, 24 weeks ]To the patient will be asked to answer " Change in SF-36 "at 4, 12, 24 weeks from baseline
- Adequate global relief of symptoms after treatment [ Time Frame: Time Frame: 2, 4, 12, 24 weeks ]
Adequate global relief of symptoms after treatment, defined by a score of at least 3 on a 7-point Likert scale of weekly relief (Clinical Global Impression - Improvement, (CGI-I) scale):
In order to assess adequate global relief, patients will be asked at each post-basal visit (from visit V2 onwards) to answer the question "Compared to how you usually felt before taking the study treatment, how would you rate your global symptom relief over the last 7 days?" Possible answers: 1, much improved; 2, improved; 3, slightly improved; 4, unchanged; 5, slightly worsened; 6, worsened; 7, much worsened.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05925595
Contact: Caterina Fossi, PHD | +39 3351894461 | cfossi@aboca.it | |
Contact: Laura Capone, PHD | +39 0575 745568 | lcapone@aboca.it |
Italy | |
Azienda Ospedaliera di Perugia | Recruiting |
Perugia, Italy, 06156 | |
Contact: Francesco Manfreda, MD francesco.manfreda@libero.it |
Principal Investigator: | Auro Caraffa, MD | Azienda Ospedaliera di Perugia |
Responsible Party: | Bios-Therapy, Physiological Systems for Health S.p.A |
ClinicalTrials.gov Identifier: | NCT05925595 |
Other Study ID Numbers: |
NBM-KOA 05/21 |
First Posted: | June 29, 2023 Key Record Dates |
Last Update Posted: | July 3, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |