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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hymovis ONE Arm | Experimental | Hymovis® ONE (32 mg/4 ml) intra-articular mono injection. Patients will be followed during 12 months including 6 visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 90 after baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | (Day 0, Day 30, Day 90, Day 180 and Day 360) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università di Roma "La Sapienza", Azienda Policlinico Umberto I, Roma | Roma | 00161 | Italy |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 | (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 | (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 | (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 | (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 | (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 | (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 | (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 | (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. | (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 | (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 | (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 | (Day 30, Day 60, Day 90, Day 135, Day 180, Day 270 and Day 360) |
| D012216 |
| Rheumatic Diseases |