Osteoarthritis, KneeNCT06433492
Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Lecithin in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.
A study testing Intra-articular injection in people with Osteoarthritis, Knee, run by Biovico Sp. z o.o. at 1 site in Poland.
Trial summary
The main objective of this prospective, open-label clinical trial is to assess the effectiveness and safety of intra-articular liposomal gel therapy for knee OA symptoms. Read more about this study
- Who is it for?
- Ages 38 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Intra-articular injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 30 Dec 2020to 21 Dec 2022
- 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 38 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 38 and 70 years,
- OA diagnosed by the American College of Rheumatology (ACR) criteria,
- OA diagnosed by radiographic imaging (grade II - III according to the Kellgren-Lawrence scale),
- Pain in the knee joint for at least 3 months,
- Screening pain intensity in the target knee measured on VAS scale was required to be 4 for symptomatic knee and 2 for the contralateral knee.
Who cannot join
- Previous injections of hyaluronic acid or platelet-rich plasma within 6 months or corticosteroid injections within 3 months before the enrollment,
- Present joint infection,
- Previous knee arthroscopy up to 1 year prior to examination,
- Peripheral inflammatory and autoimmune diseases that progress with joint involvement (rheumatoid arthritis, spondyloarthropathies, systemic lupus erythematosus etc.),
- Total arthroplasty and osteotomy,
- Ankylosis of the study joint,
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- Dermatitis or dermatological disease at the intended injection site,
- Known hypersensitivity to the components of the preparation,
- Coexistence of the degenerative changes in other limb joints (hip, foot),
- Cancer,
- Oral corticosteroid therapy,
- Use of medicines that affect blood clotting (heparins, oral anticoagulants, thrombolytic drugs),
- Pregnancy or breast-feeding.
- History of injury to the knee, a broken bone or dislocation of a joint, other musculoskeletal diseases that affect the study joint, neoplastic disease.
- Participation in other clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Liposomes in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.
The main objective of this prospective, open-label clinical trial is to assess the effectiveness and safety of intra-articular liposomal gel therapy for knee OA symptoms.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Intra-articular injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular injectionDevice
Three doses of intra-articular injection administered in weekely intervals.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 50 patients age 38-70 with OA confirmed by ACR criteria and radiologically verified OA (Kellgren-Lawrence grade 2 or 3) suffering from knee joint pain for at least 3 months and VAS pain score minimum 4 in one knee, and < 2 in the contralateral knee were subjected to the administration of Lipotris™. The product was administered as a course of three injections weekly. Receives: Device: Intra-articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain score of Visual Analog Scale (VAS) of target knee at 3 months post-treatment.
The visual analog scale (VAS) measures the severity of pain. The patient assesses the level of pain by marking a point on a line 10 cm long, where a value of 0 is assigned the complete absence of pain, and a value of 10 is assigned the most severe pain the patient can imagine.
Measured: 3 months
Secondary outcomes (8)
The pain score of VAS of target knee at baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment
The pain score of VAS of target knee at baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment.
Measured: baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment
The score of WOMAC at baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of hip and knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items.The patient assesses his condition using a scale by marking one of 5 options (scoring 0 - 4, where 0 - no complaints, 1 - mild, 2 - moderate, 3 - severe, 4 - extreme). The scores for each subscale are summed up to give a total subscale score, with higher scores indicating greater severity of symptoms.
Measured: baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment
Functional status of knee joint according to time to perform the The Timed Up and Go Test.
The TUG test measures the time it takes for a person to stand up from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: baseline, 1 month, 3 months and 6 months post-treatment
Functional status of knee joint according to time to perform the Five Time Sit to Stand Test.
To perform "The Five Time Sit to Stand Test" (FTSST, 5xSTS), patient was asked to take a sitting position on a standard 45 cm high chair with arms crossed over the chest. At the command "START," the patient must stand up as quickly as possible five times and completely straighten up and sit back in the chair without supporting himself with his arms.
Measured: baseline, 1 month, 3 months and 6 months post-treatment
Functional status of knee joint according to time to perform the to 10 Meter Walk Test.
The 10 Meter Walk Test (10MWT) is a clinical assessment tool used to evaluate a patient's walking speed and mobility. The test involves measuring the time it takes for a patient to walk 10 meters (33 feet) at normal, self-selected pace.
Measured: baseline, 1 month, 3 months and 6 months post-treatment
Maximum isometric force of flexor muscles of knee joint.
Maximal voluntary isometric contraction (MVIC) of extensor/flexor muscles of knee joint measurement was performed with Forcemeter FB 500 (AXIS, Gdansk, Poland). To measure the maximum isometric force of the knee joint extensors/flexors, a person sits on a bench with the belt around waist and legs placed freely beyond the table. The measuring belt is placed parallel to the floor just above the ankle joint with knee flexed to 90 degrees. The length of the measuring belt is specified 160 cm for extensors and 60 cm for flexors. The procedure starts with the measuring belt pretension, then the patient is asked to extend/flex the knee as hard as patient can and hold it for 6 s.
Measured: baseline, 1 month, 3 months and 6 months post-treatment
Maximum isometric force of extensor muscles of the knee joint.
Measured: baseline, 1 month, 3 months and 6 months post-treatment
Safety assesment
Number of patients with adverse events -type, duration and severity of every adverse event for each patient will be reported
Measured: baseline, 1 month, 3 months and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start30 Dec 2020
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biovico Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433492
- Sponsor's protocol ID
- 2.0 06.10.2020
- Status last verified
- May 2024
- First submitted
- 23 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Liposomes in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.
- ClinicalTrials.gov ID
- NCT06433492
- Acronym / sponsor ID
- 2.0 06.10.2020
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Biovico Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 29 May 2024 (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.
The main objective of this prospective, open-label clinical trial is to assess the effectiveness and safety of intra-articular liposomal gel therapy for knee OA symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Intra-articular injection50 patients age 38-70 with OA confirmed by ACR criteria and radiologically verified OA (Kellgren-Lawrence grade 2 or 3) suffering from knee joint pain for at least 3 months and VAS pain score minimum 4 in one knee, and < 2 in the contralateral knee were subjected to the administration of Lipotris™. The product was administered as a course of three injections weekly. |
Who may qualify
- Ages
- 38 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 38 and 70 years,
- OA diagnosed by the American College of Rheumatology (ACR) criteria,
- OA diagnosed by radiographic imaging (grade II - III according to the Kellgren-Lawrence scale),
- Pain in the knee joint for at least 3 months,
- Screening pain intensity in the target knee measured on VAS scale was required to be 4 for symptomatic knee and 2 for the contralateral knee.
Key exclusion criteria (15 listed)
- Previous injections of hyaluronic acid or platelet-rich plasma within 6 months or corticosteroid injections within 3 months before the enrollment,
- Present joint infection,
- Previous knee arthroscopy up to 1 year prior to examination,
- Peripheral inflammatory and autoimmune diseases that progress with joint involvement (rheumatoid arthritis, spondyloarthropathies, systemic lupus erythematosus etc.),
- Total arthroplasty and osteotomy,
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 |
|---|---|---|
| Intra-articular injectionThree doses of intra-articular injection administered in weekely intervals. | Device | Study group |
Primary outcome
The pain score of Visual Analog Scale (VAS) of target knee at 3 months post-treatment.
Time frame: 3 months
The visual analog scale (VAS) measures the severity of pain. The patient assesses the level of pain by marking a point on a line 10 cm long, where a value of 0 is assigned the complete absence of pain, and a value of 10 is assigned the most severe pain the patient can imagine.
8 secondary outcomes
The pain score of VAS of target knee at baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment
Time frame: baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment
The score of WOMAC at baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment
Time frame: baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment
Functional status of knee joint according to time to perform the The Timed Up and Go Test.
Time frame: baseline, 1 month, 3 months and 6 months post-treatment
Functional status of knee joint according to time to perform the Five Time Sit to Stand Test.
Time frame: baseline, 1 month, 3 months and 6 months post-treatment
Functional status of knee joint according to time to perform the to 10 Meter Walk Test.
Time frame: baseline, 1 month, 3 months and 6 months post-treatment
Maximum isometric force of flexor muscles of knee joint.
Time frame: baseline, 1 month, 3 months and 6 months post-treatment
Maximum isometric force of extensor muscles of the knee joint.
Time frame: baseline, 1 month, 3 months and 6 months post-treatment
Safety assesment
Time frame: baseline, 1 month, 3 months and 6 months post-treatment
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 29 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular injection in people with Osteoarthritis, Knee, run by Biovico Sp. z o.o. at 1 site in Poland.
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 5 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 29 May 2024. 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 Poland. 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?
The pain score of Visual Analog Scale (VAS) of target knee at 3 months post-treatment. (time frame: 3 months). 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 29 May 2024.