Durolane SJ for Treatment of Rhizarthrosis

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.

Study Overview

• Status: Completed
• Conditions: Rhizarthrosis
• Intervention / Treatment: Device: Durolane SJ

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08208
    • Corporacio Sanitaria Parc Tauli
  • Barcelona
    • Sant Joan Despí, Barcelona, Spain, 08970
      • Hospital Sant Joan Despi Moises Broggi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	Baseline and 26 weeks

Collaborators and Investigators

• Sponsor: Zambon SAU
• Collaborators: Bioventus LLC
• Investigators: Principal Investigator: Eloisa Velasco Ruiz, MD, Hospital Sant Joan Despi Moises Broggi

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: January 20, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: DURE04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes