Knee OsteoarthritisNCT04661111
Efficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome
A study testing Hymovis® ONE (32 mg/4 ml) in people with Knee Osteoarthritis, run by Fidia Farmaceutici s.p.a. at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the efficacy and safety of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteochondral lesions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hymovis® ONE (32 mg/4 ml)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jun 2016to 28 Jun 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female higher than 18 and less or equal to 65 years of age
- an active life-style, professional or regular casual sport player (people who plays sport or trains themselves at least 2-3 times per week).
- diagnosis of knee osteoarthritis will be based upon a standing weight bearing knee X-ray at Screening or an X-ray performed within 6 months prior to screening. The radiograms must be classified as a Kellgren and Lawrence Grade I-III for osteoarthritis of the knee.
- a knee VAS pain score, within 48 hours before the visit.
- patients must have had all analgesic/anti-inflammatory drugs discontinued for 2 weeks prior to Baseline except for acetaminophen.
Who cannot join
- Major injury to the contralateral knee or other weight-bearing joint if it would interfere with the study assessments.
- Surgical procedure of the studied joint within the previous 12 months prior to Screening.
- Ligament reconstruction in the target knee within 1 year
- Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic arthritis
- Intra-articular or local peri-articular corticosteroid injections to the study joint/knee within the previous 3 months prior to screening or to any other joint (beside the study joint) or soft tissue area within the previous month prior to Screening.
- Any corticosteroid within the previous month. Steroid inhalants are permitted if the patient has been on a stable regimen for the past month prior to Screening and remains on this regimen throughout the course of the trial.
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- Intra-articular hyaluronan in the studied joint within the previous 6 months prior to Screening.
- History of allergic reaction to an intra-articular Hyaluronic acid injection
- Use of glucosamine- or chondroitin sulfate-containing products unless the patient is on stable doses for at least 4 months prior to Screening and willing to remain on these stable doses throughout the course of the trial.
- Patients with X-ray findings of acute fractures, severe loss of bone density, avascular necrosis and/or severe deformity.
- Axial deviation of the lower limbs higher than 20 degrees in valgus or varus on standing X-ray.
- Symptomatic osteoarthritis of either hip, contralateral knee or spine that may interfere with functional assessment of the signal knee.
- Clinically significant medio-lateral and/or anterior-posterior instability.
- Osteonecrosis of either knee.
- If patients are receiving or performing physical therapy at Screening, this physical therapy regimen has not been stable during the one-month preceding Screening and the patient is not willing to maintain the same regimen throughout the course of the trial.
- Patients with Kellgren-Lawrence Stage IV osteoarthritis of the knee (i.e.,in grade IV large osteophytes, marked narrowing, severe sclerosis, and definite deformity).
- Hemiparesis of the lower limbs
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università di Roma "La Sapienza", Azienda Policlinico Umberto I, Roma
Roma, 00161
About this study
Official title: Prospective, Monocentric, Study to Assess Efficacy and Safety of Hymovis® ONE (32 mg/4 ml) Intra-articular Injection in Active Patients Affected by Knee Overuse Syndrome
The aim of this study is to evaluate the efficacy and safety of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteochondral lesions.
Read the detailed description
There are no studies in literature up to now, that analyze the changes in knee pain and correlate this parameter with knee function and biomechanics, in regular casual sport player subject affected by knee overuse syndrome and underwent an intra-articular HA injection. The aim of this study is to evaluate efficacy and safety of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteochondral lesions.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hymovis® ONE (32 mg/4 ml)
- Keywords
- Hyaluronic acid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hymovis® ONE (32 mg/4 ml)Device
Hymovis® ONE is a clear hydrogel. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process. Hymovis® ONE is a CE-marked Class III Medical Device intended for intra-articular injection.
| Study group | Role | What they receive |
|---|---|---|
| Hymovis ONE Arm | Experimental | Hymovis® ONE (32 mg/4 ml) intra-articular mono injection. Patients will be followed during 12 months including 6 visits. Receives: Device: Hymovis® ONE (32 mg/4 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteoarthritis due to overuse: KOOS questionnaire (Knee injury and Osteoarthritis Outcome Score)
To demonstrate that a single intra-articular (i.a.) injection of Hymovis® ONE (32 mg/4 ml) decreases the difficulties in sport and recreational activity. The efficacy will be measured evaluating the improved knee function during sport and recreational activity through the fourth item (SP1-SP5) of the KOOS questionnaire, 90 days after injection. A five-point Likert scale(LK3 series) will be used to score each of the five KOOS questionnaire items (Symptoms, Pain, Function daily living, Function in sports and recreational activities).
Measured: Day 90 after baseline visit
Secondary outcomes (13)
Knee function through WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) C scale.
To assess knee function through WOMAC C (twelve questions of WOMAC specifically evaluating joint function) scale within 48 hours before the visits. It will be measured the joint function after Hymovis® ONE injection through afive point Likert scale(LK3 series)
Measured: (Day 0, Day 30, Day 90, Day 180 and Day 360)
Gait analysis system
The difference of kinetic parameters will be measured through gait analysis before and after treatment. The following kinetic parameter will be considered for the evaluation: knee flexion moment, knee flexion angular impulse, knee adduction moment, knee adduction angular impulse
Measured: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis( tilt at heel contact evaluated per each visit reported
The difference of kinetic parameters will be measured through gait analysis before and after treatment. The following kinetic parameter will be considered for the evaluation tilt at heel contact
Measured: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis( flexion-evaluated evaluated per each visit reported )
The difference of kinetic parameters will be measured through gait analysis before and after treatment. The following kinetic parameter will be considered for the evaluation:
flexion-extension
Measured: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis(rotation RoM evaluated per each visit reported )
The difference of kinetic parameters will be measured through gait analysis before and after treatment. The following kinetic parameter will be considered for the evaluation :
rotation RoM
Measured: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis(RoM evaluated per each visit reported in the time frame).
The difference of kinetic parameters will be measured through gait analysis before and after treatment. The following kinetic parameter will be considered for the evaluation:
RoM
Measured: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis( tilt RoM evaluated per each visit reported in the time frame).
The difference of kinetic parameters will be measured through gait analysis before and after treatment. The following kinetic parameter will be considered for the evaluation:
tilt RoM
Measured: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis(flexion-extension evaluated per each visit reported in the time frame).
The difference of kinetic parameters will be measured through gait analysis before and after treatment. The following kinetic parameter will be considered for the evaluation :
flexion-extension
Measured: (Day 0, Day 30, Day 90, Day 180)
Knee pain through WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) A scale.
Knee pain through WOMAC A (five questions of WOMAC specifically evaluating pain) within 48 hours before the visits. It will be measured the knee pain relief after Hymovis® ONE injection through Likert scale
Measured: (Day 0, Day 30, Day 90, Day 180 and Day 360)
Knee pain through Visual Analogical Scale (VAS, 100 mm, where "No pain = 0" while "Worst Pain Imaginable = 100")
Knee pain through Visual Analogical Scale (VAS, 0-100 mm) within 48 hours before the visits. It will be measured the knee pain relief after Hymovis® ONE injection.
Measured: (Day 0, Day 30, Day 90, Day 180 and Day 360)
The requirement for daily rescue analgesic medication (simple analgesics, acetaminophen) for pain relief. The "rescue dose" will be acetaminophen 3 g per day.
The requirement for daily rescue analgesic medication (simple analgesics, acetaminophen) for pain relief. The "rescue dose" will be acetaminophen 3g per day. During the visits patients have to declare the quantity of rescue drug taken and have to deliver at the end of the study the drug left-over
Measured: (Day 0, Day 30, Day 90, Day 180 and Day 360)
Knee pain, function, stiffness and quality of life through KOOS ((Knee injury and Osteoarthritis Outcome Score) questionnaire.
Knee pain and function and quality of life through five items of the KOOS questionnaire. A Likert scale will be used to score each of the five KOOS questionnaire items (Symptoms, Pain, Function daily living, Function in sports and recreational activities). An aggregate score will not be calculated since it is regarded desirable to analyze and interpret the five dimensions separately
Measured: (Day 0, Day 30, Day 90, Day 180 and Day 360)
The safety of a single i.a. injections by tracking the number of patient withdrawals and their adverse events
The device safety after a single i.a. injection by tracking the number of patient withdrawals and their adverse events
Measured: (Day 30, Day 60, Day 90, Day 135, Day 180, Day 270 and Day 360)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start13 Jun 2016
- Primary completion28 Sep 2017
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661111
- Sponsor's protocol ID
- EQL2-15-01
- Status last verified
- Apr 2020
- First submitted
- 2 Mar 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Monocentric, Study to Assess Efficacy and Safety of Hymovis® ONE (32 mg/4 ml) Intra-articular Injection in Active Patients Affected by Knee Overuse Syndrome
- ClinicalTrials.gov ID
- NCT04661111
- Acronym / sponsor ID
- EQL2-15-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 10 Dec 2020 (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 aim of this study is to evaluate the efficacy and safety of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteochondral lesions.
Detailed description
There are no studies in literature up to now, that analyze the changes in knee pain and correlate this parameter with knee function and biomechanics, in regular casual sport player subject affected by knee overuse syndrome and underwent an intra-articular HA injection. The aim of this study is to evaluate efficacy and safety of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteochondral lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hymovis ONE Arm | Experimental | Device: Hymovis® ONE (32 mg/4 ml)Hymovis® ONE (32 mg/4 ml) intra-articular mono injection. Patients will be followed during 12 months including 6 visits. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female higher than 18 and less or equal to 65 years of age
- an active life-style, professional or regular casual sport player (people who plays sport or trains themselves at least 2-3 times per week).
- diagnosis of knee osteoarthritis will be based upon a standing weight bearing knee X-ray at Screening or an X-ray performed within 6 months prior to screening. The radiograms must be classified as a Kellgren and Lawrence Grade I-III for osteoarthritis of the knee.
- a knee VAS pain score, within 48 hours before the visit.
- patients must have had all analgesic/anti-inflammatory drugs discontinued for 2 weeks prior to Baseline except for acetaminophen.
Key exclusion criteria (17 listed)
- Major injury to the contralateral knee or other weight-bearing joint if it would interfere with the study assessments.
- Surgical procedure of the studied joint within the previous 12 months prior to Screening.
- Ligament reconstruction in the target knee within 1 year
- Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic arthritis
- Intra-articular or local peri-articular corticosteroid injections to the study joint/knee within the previous 3 months prior to screening or to any other joint (beside the study joint) or soft tissue area within the previous month 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 |
|---|---|---|
| Hymovis® ONE (32 mg/4 ml)Hymovis® ONE is a clear hydrogel. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process. Hymovis® ONE is a CE-marked Class III Medical Device intended for intra-articular injection. | Device | Hymovis ONE Arm |
Primary outcome
The efficacy of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteoarthritis due to overuse: KOOS questionnaire (Knee injury and Osteoarthritis Outcome Score)
Time frame: Day 90 after baseline visit
To demonstrate that a single intra-articular (i.a.) injection of Hymovis® ONE (32 mg/4 ml) decreases the difficulties in sport and recreational activity. The efficacy will be measured evaluating the improved knee function during sport and recreational activity through the fourth item (SP1-SP5) of the KOOS questionnaire, 90 days after injection. A five-point Likert scale(LK3 series) will be used to score each of the five KOOS questionnaire items (Symptoms, Pain, Function daily living, Function in sports and recreational activities).
13 secondary outcomes
Knee function through WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) C scale.
Time frame: (Day 0, Day 30, Day 90, Day 180 and Day 360)
Gait analysis system
Time frame: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis( tilt at heel contact evaluated per each visit reported
Time frame: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis( flexion-evaluated evaluated per each visit reported )
Time frame: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis(rotation RoM evaluated per each visit reported )
Time frame: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis(RoM evaluated per each visit reported in the time frame).
Time frame: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis( tilt RoM evaluated per each visit reported in the time frame).
Time frame: (Day 0, Day 30, Day 90, Day 180)
Biomechanical kinematic parameters through gait analysis(flexion-extension evaluated per each visit reported in the time frame).
Time frame: (Day 0, Day 30, Day 90, Day 180)
Knee pain through WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) A scale.
Time frame: (Day 0, Day 30, Day 90, Day 180 and Day 360)
Knee pain through Visual Analogical Scale (VAS, 100 mm, where "No pain = 0" while "Worst Pain Imaginable = 100")
Time frame: (Day 0, Day 30, Day 90, Day 180 and Day 360)
The requirement for daily rescue analgesic medication (simple analgesics, acetaminophen) for pain relief. The "rescue dose" will be acetaminophen 3 g per day.
Time frame: (Day 0, Day 30, Day 90, Day 180 and Day 360)
Knee pain, function, stiffness and quality of life through KOOS ((Knee injury and Osteoarthritis Outcome Score) questionnaire.
Time frame: (Day 0, Day 30, Day 90, Day 180 and Day 360)
The safety of a single i.a. injections by tracking the number of patient withdrawals and their adverse events
Time frame: (Day 30, Day 60, Day 90, Day 135, Day 180, Day 270 and Day 360)
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 10 Dec 2020.
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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 Hymovis® ONE (32 mg/4 ml) in people with Knee Osteoarthritis, run by Fidia Farmaceutici 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 5 inclusion and 17 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 10 Dec 2020. 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?
The efficacy of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteoarthritis due to overuse: KOOS questionnaire (Knee injury and Osteoarthritis Outcome Score) (time frame: Day 90 after baseline visit). 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 10 Dec 2020.