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| Name | Class |
|---|---|
| Bioventus LLC | INDUSTRY |
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The main objective of the trial is to assess the clinical changes in terms of physical examination, VAS Scale and the Quick-DASH questionnaire, and the biomechanical parameters in terms of mobility of the TMC joint, the grip strength of the hand and lateral pinch strength in patients with rhizarthrosis after administration of viscosupplementation.
The secondary objectives of the trial will be to assess the safety of the treatment with viscosupplementation, and the correlation between the clinical and biomechanical changes at the end of the trial.
This is a prospective, open, non-comparative study in 36 subjects with rhizarthrosis, comparing signs and symptoms before and after a single injection of DUROLANE SJ in the affected hand.
Subjects were assessed pre-treatment and at 1, 3, and 6 months post-treatment. This study is associated with a post marketing commitment with the European Notified Body, BSI, to confirm DUROLANE SJ's effectiveness in rhizarthrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durolane SJ | Experimental | single dose injection. One infiltration of the study product in the trapeziometacarpal (TMC) joint. The study treatment contains sodium hyaluronate 20 mg/mL, in a 1 mL prefilled syringe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durolane SJ | Device | DUROLANE® is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate-buffered saline at a concentration of 20 mg/mL . |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain Measured by the VAS Scale | Visual Analogue Scale (VAS) pain in injected hand. The VAS scale ranges from 0 cm (least pain) to 10 cm (most pain). A Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. | Baseline and 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Biomechanical Function, Measured by the Quick DASH Questionnaire | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities.This is a self-report questionnaire that patients can use to rate difficulty and interference with daily life. Quick DASH questionnaire is a shortened version of the DASH Outcome Measure which uses 11 items to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb. Possible scores range from 11-55, which can be remapped to a 0-100 scale. This latter ranges from 0 units (most functionality) to 100 units (least functionality). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eloisa Velasco Ruiz, MD | Hospital Sant Joan Despi Moises Broggi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Joan Despi Moises Broggi | Sant Joan Despí | Barcelona | 08970 | Spain | ||
| Hospital Universitari Vall d'Hebron |
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All subjects were assigned to the same study treatment.
35 patients will take part in the trial. Being a pilot trial, it is considered that the "n" will allow us to adequately assess the clinical and biomechanical changes in order to calculate the suitable "n" for a trial with a larger "n". Patients will be recruited from 3 centres and the recruitment of patients between centres will be competitive
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| ID | Title | Description |
|---|---|---|
| FG000 | DUROLANE SJ | Sodium hyaluronate, 20 mg/mL, single injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Set = all subjects who received any exposure to study treatment (injection). One patients of the enrolled set discontinued before injection hence was not considered in the safety set.
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| ID | Title | Description |
|---|---|---|
| BG000 | DUROLANE SJ | Sodium hyaluronate, 20 mg/mL, single injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Pain Measured by the VAS Scale | Visual Analogue Scale (VAS) pain in injected hand. The VAS scale ranges from 0 cm (least pain) to 10 cm (most pain). A Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. | Full Analysis Set: Safety Set subjects with at least 1 post injection visit effectiveness assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 26 weeks |
|
|
Throughout the study, up to 24 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DUROLANE SJ | Sodium hyaluronate, 20 mg/mL, single injection | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Esteras, MD | Zambon S.A.U. | +34 93 544 64 00 | antonio.esteras@zambongroup.com |
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|
| Baseline and 26 weeks |
| Barcelona |
| 08035 |
| Spain |
| Corporació Sanitària Parc Taulí | Barcelona | 08208 | Spain |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in Biomechanical Function, Measured by the Quick DASH Questionnaire | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities.This is a self-report questionnaire that patients can use to rate difficulty and interference with daily life. Quick DASH questionnaire is a shortened version of the DASH Outcome Measure which uses 11 items to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb. Possible scores range from 11-55, which can be remapped to a 0-100 scale. This latter ranges from 0 units (most functionality) to 100 units (least functionality). | Full Analysis Set: Safety Set subjects with at least 1 post injection visit effectiveness assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 26 weeks |
|
|
|
| 35 |
| 0 |
| 35 |
| 4 |
| 35 |
| Swelling | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Post Inflammation | General disorders | MedDRA (17.0) | Systematic Assessment |
|
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