Rhizarthrosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDurolane SJ
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 .
Sponsors
Bioventus LLC
Zambon SAU
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects of both sexes aged 18 to 75 years. * Diagnosis of Grade II-III rhizarthrosis in either hand, according to the criteria of Eaton and Littler. * TMC joint pain lasting longer than 6 months and baseline pain value greater than or equal to 4 on the VAS scale (0 to 10) and less than 4 in the contralateral hand joint if there is pain.
Exclusion criteria
* Anticoagulant medication * Rheumatic disease involving the wrist, hand and fingers, such as rheumatoid arthritis or gout * Active rheumatoid arthritis * Previous surgery of the hand * Systemic infectious processes * Neoplastic disease * Subjects with contraindications to hyaluronic acid * Subjects with known hypersensitivity to hyaluronic acid or any of the components of the preparation under study * Previous hyaluronic acid injections in the hand * Subjects likely to miss the clinical follow-up visits * Taking of analgesics 24 hours before scheduled clinical assessments * Pregnant subjects * Any condition that in the opinion of the physician recommends exclusion of the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Measured by the VAS Scale | Baseline and 26 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Biomechanical Function, Measured by the Quick DASH Questionnaire | Baseline and 26 weeks | 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). |
Countries
Spain
Participant flow
Recruitment details
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
Pre-assignment details
All subjects were assigned to the same study treatment.
Participants by arm
| Arm | Count |
|---|---|
| DUROLANE SJ Sodium hyaluronate, 20 mg/mL, single injection | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | DUROLANE SJ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 60.8 years STANDARD_DEVIATION 61.9 |
| Region of Enrollment Spain | 35 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 4 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
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.
Time frame: Baseline and 26 weeks
Population: Full Analysis Set: Safety Set subjects with at least 1 post injection visit effectiveness assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DUROLANE SJ | Change From Baseline in Pain Measured by the VAS Scale | -2.00 units on a scale | Standard Error 0.28 |
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).
Time frame: Baseline and 26 weeks
Population: Full Analysis Set: Safety Set subjects with at least 1 post injection visit effectiveness assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DUROLANE SJ | Change From Baseline in Biomechanical Function, Measured by the Quick DASH Questionnaire | -10.8 units on a scale | Standard Error 2.36 |