the Treatment of Knee OsteoarthritisNCT05925595
Intra-articular Administration of Med Device Made of Biological Vegetal Matrix for the Treatment of Knee Osteoarthritis
A study testing Medical Device Iniettabile Ginocchio in people with the Treatment of Knee Osteoarthritis, run by Bios-Therapy, Physiological Systems for Health S.p.A at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- the Treatment of Knee Osteoarthritis
- What is being tested?
- Medical Device Iniettabile Ginocchio
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 6 Dec 2022to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
150 patients diagnosed with primary knee osteoarthritis will be enrolled by up to 3 centers.
The study includes 7 visits at the site center.
V-1 (eligibility assessment / screening visit):
- Collection of written informed consent
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Diagnosed with radiologically confirmed primary osteoarthritis of the knee according to American College of Rheumatology criteria (i.e. one or more osteophytes and a measurable joint space on a plain radiograph taken within 3 months prior to screening).
- Blood tests: glycemia, creatinine, complete blood count with formula, ALT, AST, ALP, calcium, potassium, sodium, C reactive protein, total bilirubin. Urinalysis.
- Advice on daily diary writing to collect the number of concomitant medication before V0
- Recording of adverse events and concomitant therapies in the daily diary
V0 (confirmation of possession of selection criteria):
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Randomization 1:1 to Investigational device or active comparator Jonexa
- Intra-articular administration
- Observation of the patient for 30 minutes post injection
- Compliance with daily diary completion
- Administration of questionnaires: WOMAC Pain and Function, SF-36 and global symptom relief questionnaire (CGI- I).
- Recording of any changes in concomitant therapies and any adverse events.
V1(Day 3): safety visit (3 days after V0)
- Objective examination, including measurement of vital parameters (weight, diastolic/systolic blood pressure, heart rate).
- Safety evaluation and AEs recording and Concomitant Therapies
- Checking the completion of the daily diary.
V2 (V2, week 2 ± 2 days) follow-up visit:
- Objective examination, including measurement of vital parameters (weight, diastolic/systolic blood pressure, heart rate).
- Checking the completion of the daily diary.
- Administration of the global symptom relief questionnaire (CGI- I).
- Administration of the WOMAC Pain questionnaire.
- Recording of adverse events and concomitant therapies.
- Instruction to fill in the daily diary via web app (smart phone) to report the use of all concomitant therapies. If patient is not able to use web app, a paper copy will be given.
V3 (V3, week 4 ± 2 days): follow-up visit:
- Objective examination, including measurement of vital parameters (weight, diastolic/systolic blood pressure, heart rate).
- Checking the completion of the daily diary.
- Administration of the global symptom relief questionnaire (CGI- I).
- Questionnaire administration: WOMAC Pain and Function, SF-36.
- Recording of adverse events and concomitant therapies.
- Instruction to fill in the daily diary via web app (smart phone) to report the use of all concomitant therapies. If patient is not able to use web app, a paper copy will be given.
V4 (V4, week 12 ± 2 days) follow-up visit:
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Check of daily diary
- Administration of the global symptom relief questionnaire (CGI- I).
- Questionnaire administration: WOMAC Pain and Function, SF-36.
- Recording of adverse events and concomitant therapies.
- Instruction to fill in the daily diary via web app (smart phone) to report the use of all concomitant therapies. If patient is not able to use web app, a paper copy will be given.
V5 (V5, week 24 ± 3 days) end-of-study or premature discontinuation visit:
- Objective examination, including measurement of vital parameters
- Blood tests: blood glucose, creatinine, blood count with formula,AST, ALP, calcemia, potassium, sodium, C-reactive protein, total bilirubin. Urine examination.
- Check of completion of the daily diary.
- Administration of the global symptom relief questionnaire (CGI- I).
- Questionnaire administration: WOMAC Pain and Function, SF-36.
- Recording of adverse events and concomitant therapies.
- Conditions
- the Treatment of Knee Osteoarthritis
- Being tested
- Medical Device Iniettabile Ginocchio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device Iniettabile GinocchioDevice
Knee injection of the investigational device( MD Iniettabile Ginocchio) versus active comparator (Jonexa).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Arm: Medical Device Iniettabile Ginocchio Receives: Device: Medical Device Iniettabile Ginocchio |
| Comparator Arm | Active comparator | Arm: Medical Device Jonexa (active comparator medical device from the market ) Receives: Device: Medical Device Iniettabile Ginocchio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Time Frame: 14 days]
Secondary outcomes (4)
Change from baseline in WOMAC function
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
Measured: Time Frame: 14 days
Change in WOMAC pain and function at 4, 12, 24 weeks from baseline
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
Measured: Time Frame: baseline, 4, 12, 24 weeks
Change in SF-36 at 4, 12, 24 weeks from baseline
To the patient will be asked to answer " Change in SF-36 "at 4, 12, 24 weeks from baseline
Measured: Time Frame: baseline, 4, 12, 24 weeks
Adequate global relief of symptoms after treatment
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.
Measured: Time Frame: 2, 4, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start6 Dec 2022
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Treatment of Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bios-Therapy, Physiological Systems for Health S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Auro Caraffa, MD, Principal investigator, Azienda Ospedaliera di Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925595
- Sponsor's protocol ID
- NBM-KOA 05/21
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05925595
- Acronym / sponsor ID
- NBM-KOA 05/21
- Conditions
- the Treatment of Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bios-Therapy, Physiological Systems for Health S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
150 patients diagnosed with primary knee osteoarthritis will be enrolled by up to 3 centers.
The study includes 7 visits at the site center.
V-1 (eligibility assessment / screening visit):
- Collection of written informed consent
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Diagnosed with radiologically confirmed primary osteoarthritis of the knee according to American College of Rheumatology criteria (i.e. one or more osteophytes and a measurable joint space on a plain radiograph taken within 3 months prior to screening).
- Blood tests: glycemia, creatinine, complete blood count with formula, ALT, AST, ALP, calcium, potassium, sodium, C reactive protein, total bilirubin. Urinalysis.
- Advice on daily diary writing to collect the number of concomitant medication before V0
- Recording of adverse events and concomitant therapies in the daily diary
V0 (confirmation of possession of selection criteria):
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Randomization 1:1 to Investigational device or active comparator Jonexa
- Intra-articular administration
- Observation of the patient for 30 minutes post injection
- Compliance with daily diary completion
- Administration of questionnaires: WOMAC Pain and Function, SF-36 and global symptom relief questionnaire (CGI- I).
- Recording of any changes in concomitant therapies and any adverse events.
V1(Day 3): safety visit (3 days after V0)
- Objective examination, including measurement of vital parameters (weight, diastolic/systolic blood pressure, heart rate).
- Safety evaluation and AEs recording and Concomitant Therapies
- Checking the completion of the daily diary.
V2 (V2, week 2 ± 2 days) follow-up visit:
- Objective examination, including measurement of vital parameters (weight, diastolic/systolic blood pressure, heart rate).
- Checking the completion of the daily diary.
- Administration of the global symptom relief questionnaire (CGI- I).
- Administration of the WOMAC Pain questionnaire.
- Recording of adverse events and concomitant therapies.
- Instruction to fill in the daily diary via web app (smart phone) to report the use of all concomitant therapies. If patient is not able to use web app, a paper copy will be given.
V3 (V3, week 4 ± 2 days): follow-up visit:
- Objective examination, including measurement of vital parameters (weight, diastolic/systolic blood pressure, heart rate).
- Checking the completion of the daily diary.
- Administration of the global symptom relief questionnaire (CGI- I).
- Questionnaire administration: WOMAC Pain and Function, SF-36.
- Recording of adverse events and concomitant therapies.
- Instruction to fill in the daily diary via web app (smart phone) to report the use of all concomitant therapies. If patient is not able to use web app, a paper copy will be given.
V4 (V4, week 12 ± 2 days) follow-up visit:
- Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate)
- Check of daily diary
- Administration of the global symptom relief questionnaire (CGI- I).
- Questionnaire administration: WOMAC Pain and Function, SF-36.
- Recording of adverse events and concomitant therapies.
- Instruction to fill in the daily diary via web app (smart phone) to report the use of all concomitant therapies. If patient is not able to use web app, a paper copy will be given.
V5 (V5, week 24 ± 3 days) end-of-study or premature discontinuation visit:
- Objective examination, including measurement of vital parameters
- Blood tests: blood glucose, creatinine, blood count with formula,AST, ALP, calcemia, potassium, sodium, C-reactive protein, total bilirubin. Urine examination.
- Check of completion of the daily diary.
- Administration of the global symptom relief questionnaire (CGI- I).
- Questionnaire administration: WOMAC Pain and Function, SF-36.
- Recording of adverse events and concomitant therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: Medical Device Iniettabile GinocchioArm: Medical Device Iniettabile Ginocchio |
| Comparator Arm | Active comparator | Device: Medical Device Iniettabile GinocchioArm: Medical Device Jonexa (active comparator medical device from the market ) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device Iniettabile GinocchioKnee injection of the investigational device( MD Iniettabile Ginocchio) versus active comparator (Jonexa). | Device | Comparator Arm, Experimental Arm |
Primary outcome
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.
4 secondary outcomes
Change from baseline in WOMAC function
Time frame: Time Frame: 14 days
Change in WOMAC pain and function at 4, 12, 24 weeks from baseline
Time frame: Time Frame: baseline, 4, 12, 24 weeks
Change in SF-36 at 4, 12, 24 weeks from baseline
Time frame: Time Frame: baseline, 4, 12, 24 weeks
Adequate global relief of symptoms after treatment
Time frame: Time Frame: 2, 4, 12, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Auro Caraffa, MD principal investigator
Azienda Ospedaliera di Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device Iniettabile Ginocchio in people with the Treatment of Knee Osteoarthritis, run by Bios-Therapy, Physiological Systems for Health S.p.A at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change at 2 weeks from baseline in WOMAC Pain (time frame: [Time Frame: 14 days]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.