Trial Outcomes & Findings for Durolane SJ for Treatment of Rhizarthrosis (NCT NCT02676284)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Baseline and 26 weeks

Results posted on

2021-12-03

Participant Flow

35 patients will take part in the trial. Being a pilot trial, it is considered that the "n" will allow us to adequately assess the clinical and biomechanical changes in order to calculate the suitable "n" for a trial with a larger "n". Patients will be recruited from 3 centres and the recruitment of patients between centres will be competitive

All subjects were assigned to the same study treatment.

Participant milestones

Participant milestones
Measure	DUROLANE SJ Sodium hyaluronate, 20 mg/mL, single injection
Overall Study STARTED	36
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	DUROLANE SJ Sodium hyaluronate, 20 mg/mL, single injection
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Durolane SJ for Treatment of Rhizarthrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DUROLANE SJ n=35 Participants Sodium hyaluronate, 20 mg/mL, single injection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	60.8 years STANDARD_DEVIATION 61.9 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment Spain	35 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 26 weeks

Population: Full Analysis Set: Safety Set subjects with at least 1 post injection visit effectiveness assessment.

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.

Outcome measures

Outcome measures
Measure	DUROLANE SJ n=35 Participants Sodium hyaluronate, 20 mg/mL, single injection
Change From Baseline in Pain Measured by the VAS Scale	-2.00 units on a scale Standard Error 0.28

SECONDARY outcome

Timeframe: Baseline and 26 weeks

Population: Full Analysis Set: Safety Set subjects with at least 1 post injection visit effectiveness assessment.

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).

Outcome measures

Outcome measures
Measure	DUROLANE SJ n=35 Participants Sodium hyaluronate, 20 mg/mL, single injection
Change From Baseline in Biomechanical Function, Measured by the Quick DASH Questionnaire	-10.8 units on a scale Standard Error 2.36

Adverse Events

DUROLANE SJ

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DUROLANE SJ n=35 participants at risk Sodium hyaluronate, 20 mg/mL, single injection
General disorders Pain	8.6% 3/35 • Number of events 3 • Throughout the study, up to 24 weeks.
General disorders Swelling	2.9% 1/35 • Number of events 1 • Throughout the study, up to 24 weeks.
General disorders Post Inflammation	2.9% 1/35 • Number of events 1 • Throughout the study, up to 24 weeks.

Additional Information

Antonio Esteras, MD

Zambon S.A.U.

Phone: +34 93 544 64 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place