Arthroscopic Meniscal Surgery Clinical Trial
Official title:
Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery.
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | April 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Male and female patients between 18 and 75 years of age. - Good general health condition. - Signed written informed consent. - Patients with necessity for arthroscopic meniscal surgery. - Ensured compliance of subject over the whole study period. Exclusion Criteria: - Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion. - Knee joint arthroscopy in study relevant joint within 6 months prior to study inclusion. - Patients with known hypersensitivity to the investigational device (i.e. active compound and excipients) or any component or procedure used in the study. - Contraindication for the use of the investigational product or for the scheduled arthroscopy, used anesthesia and post-surgical treatment. - Concomitant disease of sufficient severity (e.g. uncontrolled diabetes mellitus, carcinoma, etc.), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study. - Concomitant disease of sufficient severity at study relevant joint (e.g. known or suspected infection, peripheral neuropathy or presence of hemarthros). - List of concomitant medications not allowed which interfere with the functional assessments of this study. - Use of medication contraindicated for arthroscopic surgery. - Intra-articular treatment with a sodium hyaluronate-based product within the last 6 months or use of corticosteroid containing substance within the last 3 months at study relevant joint. - Recent history of drug and/or alcohol abuse (within the last 6 months) or patients with severe mental illness or suicidal tendency. - Pregnant or lactating females. - Participants of childbearing age (pre-menopausal) who do not accept the use of methods of birth control with pearl index = 1% (i.e. oral contraceptives, vaginal ring, hormone-releasing Intrauterine Device (IUD), implants, depot syringes, hormone patch, double barrier method, tubal ligation, vasectomised partner,…) during the treatment period and the first 4 weeks of follow-up period. - Subjects having a high probability of non-compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient knowledge of local language). - Kellgren III-IV on study relevant side (confirmed by X-ray). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | AZ Monica, Orthopedisch centrum SPM | Deurne |
| Lead Sponsor | Collaborator |
|---|---|
| TRB Chemedica AG |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | Pain evaluation (ordinal 11-point Likert scale) on day 14. | Intensity of pain will be evaluated on 11-point Likert ordinal scale ranging from '0' (no pain) to '10' (extreme pain). | Day 14 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Health-related quality of life questionnaire at baseline. | The descriptive system of health-related quality of life states consists of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression. 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 | No |
| Secondary | Health-related quality of life questionnaire on day of arthroscopy. | The descriptive system of health-related quality of life states consists of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression. 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 | No |
| Secondary | Health-related quality of life questionnaire on day 14. | The descriptive system of health-related quality of life states consists of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression. 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 | No |
| Secondary | Health-related quality of life questionnaire on day 42. | The descriptive system of health-related quality of life states consists of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression. 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 | No |
| Secondary | Health-related quality of life questionnaire on day 84. | The descriptive system of health-related quality of life states consists of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression. 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 | No |
| Secondary | Joint Examination Parameters at baseline. | Joint Examination comprises Intensity of effusion (measured by 5-point scale, ranking from 'none' to 'extreme' intensity), Necessity of puncture, Clinical parameters: redness, warmth, swelling, tenderness on palpation (measured by 5-point Likert scale, ranging from 'none' to 'extreme' intensity). |
At baseline | No |
| Secondary | Joint Examination Parameters on day of arthroscopy. | Joint Examination comprises Intensity of effusion (measured by 5-point scale, ranking from 'none' to 'extreme' intensity), Necessity of puncture, Clinical parameters: redness, warmth, swelling, tenderness on palpation (measured by 5-point Likert scale, ranging from 'none' to 'extreme' intensity). |
On Day 0 | No |
| Secondary | Joint Examination Parameters on day 14. | Joint Examination comprises Intensity of effusion (measured by 5-point scale, ranking from 'none' to 'extreme' intensity), Necessity of puncture, Clinical parameters: redness, warmth, swelling, tenderness on palpation (measured by 5-point Likert scale, ranging from 'none' to 'extreme' intensity). |
On Day 14 | No |
| Secondary | Joint Examination Parameters on day 42. | Joint Examination comprises Intensity of effusion (measured by 5-point scale, ranking from 'none' to 'extreme' intensity), Necessity of puncture, Clinical parameters: redness, warmth, swelling, tenderness on palpation (measured by 5-point Likert scale, ranging from 'none' to 'extreme' intensity). |
On Day 42 | No |
| Secondary | Joint Examination Parameters on day 84. | Joint Examination comprises Intensity of effusion (measured by 5-point scale, ranking from 'none' to 'extreme' intensity), Necessity of puncture, Clinical parameters: redness, warmth, swelling, tenderness on palpation (measured by 5-point Likert scale, ranging from 'none' to 'extreme' intensity). |
On Day 84 | No |
| Secondary | Frequency of test product-related Adverse Events | Up to Day 84 | Yes | |
| Secondary | 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 | No |
| Secondary | 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 | No |