Durolane SJ for Treatment of Rhizarthrosis

NCT02676284 | Completed Results FDA Device

• 1 other identifier: DURE04
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Rhizarthrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Biomechanical Function, Measured by the Quick DASH Questionnaire

  Baseline and 26 weeks

Study Arms (1)

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.

Device: Durolane SJ

Interventions

Durolane SJ 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 .

Durolane SJ

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zambon SAU: lead
• Bioventus LLC: collaborator

Study Sites (3)

Hospital Sant Joan Despi Moises Broggi

Sant Joan Despí, Barcelona, 08970, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Corporació Sanitària Parc Taulí

Barcelona, 08208, Spain

Location

Results Point of Contact

• Title: Antonio Esteras, MD
• Organization: Zambon S.A.U.

antonio.esteras@zambongroup.com

+34 93 544 64 00

Study Officials

• Eloisa Velasco Ruiz, MD

  Hospital Sant Joan Despi Moises Broggi

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: February 8, 2016
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 3, 2021
• Results First Posted: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)