Back to resultsEfficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hymovis® ONE (32 mg/4 ml)
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Hyaluronic acid
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Università di Roma "La Sapienza", Azienda Policlinico Umberto I, Roma
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hymovis ONE Arm
Arm Description
Hymovis® ONE (32 mg/4 ml) intra-articular mono injection. Patients will be followed during 12 months including 6 visits.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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)
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
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
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
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
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
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
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
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
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.
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
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
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
Full Information
NCT ID
NCT04661111
First Posted
March 2, 2020
Last Updated
December 2, 2020
Sponsor
Fidia Farmaceutici s.p.a.
1. Study Identification
Unique Protocol Identification Number
NCT04661111
Brief Title
Efficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 13, 2016 (Actual)
Primary Completion Date
September 28, 2017 (Actual)
Study Completion Date
June 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fidia Farmaceutici s.p.a.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Hyaluronic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hymovis ONE Arm
Arm Type
Experimental
Arm Description
Hymovis® ONE (32 mg/4 ml) intra-articular mono injection. Patients will be followed during 12 months including 6 visits.
Intervention Type
Device
Intervention Name(s)
Hymovis® ONE (32 mg/4 ml)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
Day 90 after baseline visit
Secondary Outcome Measure Information:
Title
Knee function through WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) C scale.
Description
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)
Time Frame
(Day 0, Day 30, Day 90, Day 180 and Day 360)
Title
Gait analysis system
Description
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
Time Frame
(Day 0, Day 30, Day 90, Day 180)
Title
Biomechanical kinematic parameters through gait analysis( tilt at heel contact evaluated per each visit reported
Description
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
Time Frame
(Day 0, Day 30, Day 90, Day 180)
Title
Biomechanical kinematic parameters through gait analysis( flexion-evaluated evaluated per each visit reported )
Description
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
Time Frame
(Day 0, Day 30, Day 90, Day 180)
Title
Biomechanical kinematic parameters through gait analysis(rotation RoM evaluated per each visit reported )
Description
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
Time Frame
(Day 0, Day 30, Day 90, Day 180)
Title
Biomechanical kinematic parameters through gait analysis(RoM evaluated per each visit reported in the time frame).
Description
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
Time Frame
(Day 0, Day 30, Day 90, Day 180)
Title
Biomechanical kinematic parameters through gait analysis( tilt RoM evaluated per each visit reported in the time frame).
Description
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
Time Frame
(Day 0, Day 30, Day 90, Day 180)
Title
Biomechanical kinematic parameters through gait analysis(flexion-extension evaluated per each visit reported in the time frame).
Description
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
Time Frame
(Day 0, Day 30, Day 90, Day 180)
Title
Knee pain through WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) A scale.
Description
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
Time Frame
(Day 0, Day 30, Day 90, Day 180 and Day 360)
Title
Knee pain through Visual Analogical Scale (VAS, 100 mm, where "No pain = 0" while "Worst Pain Imaginable = 100")
Description
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.
Time Frame
(Day 0, Day 30, Day 90, Day 180 and Day 360)
Title
The requirement for daily rescue analgesic medication (simple analgesics, acetaminophen) for pain relief. The "rescue dose" will be acetaminophen 3 g per day.
Description
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
Time Frame
(Day 0, Day 30, Day 90, Day 180 and Day 360)
Title
Knee pain, function, stiffness and quality of life through KOOS ((Knee injury and Osteoarthritis Outcome Score) questionnaire.
Description
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
Time Frame
(Day 0, Day 30, Day 90, Day 180 and Day 360)
Title
The safety of a single i.a. injections by tracking the number of patient withdrawals and their adverse events
Description
The device safety after a single i.a. injection 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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Facility Information:
Facility Name
Università di Roma "La Sapienza", Azienda Policlinico Umberto I, Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome
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