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The primary objective of this clinical investigation is to determine whether post-arthroscopic treatment with 10 ml of 0.5% sodium hyaluronate (VISCOSEAL® SYRINGE) can relief pain, improve mobility and promote joint recovery, compared to the standard arthroscopy procedure alone, in patients undergoing arthroscopic procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VISCOSEAL® SYRINGE | Active Comparator |
| |
| Standard arthroscopic meniscal surgery | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronan (0.5%, 5 mg/10 ml) | Device | Standard arthroscopic meniscal surgery and add-on treatment with VISCOSEAL® SYRINGE. Single injection of Hyaluronan directly after arthroscopic procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain evaluation (ordinal 11-point Likert scale) on day 84. | Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain). | Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain evaluation (ordinal 11-point Likert scale) on day of arthroscopy. | Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain). | Day 0 |
| Pain evaluation (ordinal 11-point Likert scale) on day 14. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger van Riet, MD | AZ Monica, Orthopedisch centrum SPM, Deurne (Belgium) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Monica, Orthopedisch centrum SPM | Deurne | 2100 | Belgium |
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| Standard arthroscopic meniscal surgery | Procedure | Standard arthroscopic meniscal surgery without add-on treatment. |
|
Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain). |
| Day 14 |
| Pain evaluation (ordinal 11-point Likert scale) on day 42. | Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain). | Day 42 |
| Patient's and investigator's global evaluation of study-relevant knee complaints on day 14. | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition. | On Day 14 |
| Patient's and investigator's global evaluation of study-relevant knee complaints on day 42. | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition. | On Day 42 |
| Patient's and investigator's global evaluation of study-relevant knee complaints on day 84. | Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition. | On Day 84 |
| Range of Motion at baseline. | Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree. | Baseline |
| Range of Motion on day of arthroscopy. | Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree. | On Day 0 |
| Range of Motion on day 14. | Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree. | On Day 14 |
| Range of Motion on day 42. | Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree. | On Day 42 |
| Range of Motion on day 84. | Range of Motion of the study relevant knee will be evaluated by a handheld goniometer using the Neutral-0-Method. Measurement unit: degree. | On Day 84 |
| Walking ability on day of arthroscopy. | Patient's walking ability will be evaluated with respect to difficulty on walking 100 metres and pain on walking 100 metres. Measured by 5-point scale, ranking from 'none' to 'extreme' difficulty. | On Day 0 |
| Walking ability on day 14. | Patient's walking ability will be evaluated with respect to difficulty on walking 100 metres and pain on walking 100 metres. Measured by 5-point scale, ranking from 'none' to 'extreme' difficulty. | On Day 14 |
| Walking ability on day 42. | Patient's walking ability will be evaluated with respect to difficulty on walking 100 metres and pain on walking 100 metres. Measured by 5-point scale, ranking from 'none' to 'extreme' difficulty. | On Day 42 |
| Walking ability on day 84. | Patient's walking ability will be evaluated with respect to difficulty on walking 100 metres and pain on walking 100 metres. Measured by 5-point scale, ranking from 'none' to 'extreme' difficulty. | On Day 84 |
| Health-related quality of life questionnaire at baseline. | The descriptive system of health-related quality of life states consists of five dimensions:
The responses record three levels of severity (no problems/some or moderate problems/extreme problems). For recording the individual's rating for their current health-related quality of life state, a standard vertical 20 cm visual analogue scale (similar to a thermometer) is utilised. | At baseline |
| Health-related quality of life questionnaire on day of arthroscopy. | The descriptive system of health-related quality of life states consists of five dimensions:
The responses record three levels of severity (no problems/some or moderate problems/extreme problems). For recording the individual's rating for their current health-related quality of life state, a standard vertical 20 cm visual analogue scale (similar to a thermometer) is utilised. | On day 0 |
| Health-related quality of life questionnaire on day 14. | The descriptive system of health-related quality of life states consists of five dimensions:
The responses record three levels of severity (no problems/some or moderate problems/extreme problems). For recording the individual's rating for their current health-related quality of life state, a standard vertical 20 cm visual analogue scale (similar to a thermometer) is utilised. | On day 14 |
| Health-related quality of life questionnaire on day 42. | The descriptive system of health-related quality of life states consists of five dimensions:
The responses record three levels of severity (no problems/some or moderate problems/extreme problems). For recording the individual's rating for their current health-related quality of life state, a standard vertical 20 cm visual analogue scale (similar to a thermometer) is utilised. | On day 42 |
| Health-related quality of life questionnaire on day 84. | The descriptive system of health-related quality of life states consists of five dimensions:
The responses record three levels of severity (no problems/some or moderate problems/extreme problems). For recording the individual's rating for their current health-related quality of life state, a standard vertical 20 cm visual analogue scale (similar to a thermometer) is utilised. | On day 84 |
| Joint Examination Parameters at baseline. | Joint Examination comprises
| At baseline |
| Joint Examination Parameters on day of arthroscopy. | Joint Examination comprises
| On Day 0 |
| Joint Examination Parameters on day 14. | Joint Examination comprises
| On Day 14 |
| Joint Examination Parameters on day 42. | Joint Examination comprises
| On Day 42 |
| Joint Examination Parameters on day 84. | Joint Examination comprises
| On Day 84 |
| Frequency of test product-related Adverse Events | Up to Day 84 |
| Pain evaluation (ordinal 11-point Likert scale) at baseline. | Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain). | Baseline |
| Walking ability at baseline. | Patient's walking ability will be evaluated with respect to difficulty on walking 100 metres and pain on walking 100 metres. Measured by 5-point scale, ranking from 'none' to 'extreme' difficulty. | Baseline |