RhizarthrosisNCT02676284
Durolane SJ for Treatment of Rhizarthrosis
A study testing Durolane SJ in people with Rhizarthrosis, run by Zambon SAU at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rhizarthrosis
- What is being tested?
- Durolane SJ
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesSpain
- Study dates
- May 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Corporació Sanitària Parc Taulí
Barcelona, 08208
Hospital Sant Joan Despi Moises Broggi
Sant Joan Despí, Barcelona, 08970
About this study
Official title: Study of the Clinical and Biomechanical Effectiveness of Durolane SJ in Rhizarthrosis
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.
Read the 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.
- Conditions
- Rhizarthrosis
- Being tested
- Durolane SJ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durolane SJDevice
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Durolane SJ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 26 weeks
Secondary outcomes (1)
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).
Measured: Baseline and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startMay 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RhizarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zambon SAU
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioventus LLC
- Responsible party
- Sponsor
- Investigators
- Eloisa Velasco Ruiz, MD, Principal investigator, Hospital Sant Joan Despi Moises Broggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676284
- Sponsor's protocol ID
- DURE04
- Status last verified
- Dec 2021
- First submitted
- 20 Jan 2016
- Last updated
- 3 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Clinical and Biomechanical Effectiveness of Durolane SJ in Rhizarthrosis
- ClinicalTrials.gov ID
- NCT02676284
- Acronym / sponsor ID
- DURE04
- Conditions
- Rhizarthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Zambon SAUIndustry (pharma, biotech, devices)
- Collaborators
- Bioventus LLC
- Study start
- May 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Posted 3 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durolane SJ | Experimental | Device: Durolane SJsingle 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Durolane SJDUROLANE® 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 . | Device | Durolane SJ |
Primary outcome
Change From Baseline in Pain Measured by the VAS Scale
Time frame: 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.
1 secondary outcome
Change From Baseline in Biomechanical Function, Measured by the Quick DASH Questionnaire
Time frame: Baseline and 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eloisa Velasco Ruiz, MD principal investigator
Hospital Sant Joan Despi Moises Broggi
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Durolane SJ in people with Rhizarthrosis, run by Zambon SAU at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pain Measured by the VAS Scale (time frame: Baseline and 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.