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Durolane SJ for Treatment of Rhizarthrosis

NCT ID: NCT02676284

Last Updated: 2021-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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

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Rhizarthrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Durolane SJ

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.

Group Type EXPERIMENTAL

Durolane SJ

Intervention Type 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 .

Interventions

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Durolane 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 .

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bioventus LLC

INDUSTRY

Sponsor Role collaborator

Zambon SAU

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eloisa Velasco Ruiz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sant Joan Despi Moises Broggi

Locations

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Hospital Sant Joan Despi Moises Broggi

Sant Joan Despí, Barcelona, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Corporació Sanitària Parc Taulí

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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DURE04

Identifier Type: -

Identifier Source: org_study_id