Clinical trial NCT02676284: Durolane SJ for Treatment of Rhizarthrosis
Official title: Study of the Clinical and Biomechanical Effectiveness of Durolane SJ in Rhizarthrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhizarthrosis
Lead sponsor: Zambon SAU
Sponsor class: INDUSTRY
Collaborators: name: Bioventus LLC
First posted: 2016-02-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Pain Measured by the VAS Scale
timeFrame: Baseline and 26 weeks
Secondary outcomes:
measure: Change From Baseline in Biomechanical Function, Measured by the Quick DASH Questionnaire
timeFrame: Baseline and 26 weeks
Other outcomes:
Locations:
city: Sant Joan Despí
country: Spain
facility: Hospital Sant Joan Despi Moises Broggi
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Corporació Sanitària Parc Taulí
Study officials:
affiliation: Hospital Sant Joan Despi Moises Broggi
name: Eloisa Velasco Ruiz, MD
role: PRINCIPAL_INVESTIGATOR
References: