Trial to Assess the Structural Effect and Long-term Symptomatic Relief of Intra-articular Injections of Hyaluronic Acid in Primary Knee OA

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02280538
• Date of registration: 29/10/2014
• Prospective Registration: No
• Primary sponsor: Universidade Nova de Lisboa
• Public title: Trial to Assess the Structural Effect and Long-term Symptomatic Relief of Intra-articular Injections of Hyaluronic Acid in Primary Knee OA ViscOA
• Scientific title: A Randomized Placebo Controlled Trial to Assess the Structural Effect and Long-term Symptomatic Relief of Repeated Intra-articular Injections of Hyaluronic Acid in Primary Knee Osteoarthritis
• Date of first enrolment: April 2014
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02280538
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Portugal

Contacts

• Name: Jaime C Branco, MD, PhD
• Affiliation: CEDOC

• Name: Alexandre Sepriano, MD
• Affiliation: Centro Hospitalar de Lisboa Ocidental

• Name: João Gomes, MD
• Affiliation: Centro Hospitalar de Lisboa Ocidental

• Name: Alexandre Sepriano, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Symptomatic knee OA as defined by the ACR clinical and radiographic criteria

- Kellgren-Lawrence grade of II or III on prior x-rays (taken within 6 months of the
screen visit) or screen X-ray

- A minimum medial and/or lateral JSW of the target knee of 2 mm

- Knee pain of 40 mm or greater on a 100 mm visual analogue scale (VAS) at any time
during the week before inclusion

- Oral corticosteroids (=10 mg/day prednisolone or equivalent), NSAIDs, and
acetaminophen are permitted if the dose had been stable for at least one month prior
to baseline

Exclusion Criteria:

- Body mass index greater than 40 kg/m2

- Varus or valgus deformity of the knee > 15 degrees (assessed by goniometry)

- History of trauma, surgery or planned surgery to the study joint (including
arthroscopy surgery), joint inflammatory diseases, septic arthritis and/or
microcrystalline arthropathies

- Coagulation/platelet disorders

- Active malignancy, active systemic infection, or any contraindication to MRI

- Potent analgesics including opiates, oral corticosteroid therapy within one month
prior to enrolment into the study other than stable doses of = 10 mg daily
prednisolone or equivalent

- Knee administration of intra-articular steroids in the previous 3 months or HA
injections during the past year



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoarthritis Of Knee

Intervention(s)

Device: Intra-Articular Hyaluronic Acid

Device: Placebo

Primary Outcome(s)

Joint Space Width [Time Frame: 2 years]

Secondary Outcome(s)

OMERACT/OARSI 2004 response [Time Frame: 6 months]

SF-36 questionnaire - Mental Score [Time Frame: 2 years]

Euro QoL 5D [Time Frame: 2 years]

SF-36 questionnaire - Physical Score [Time Frame: 2 years]

Adverse events [Time Frame: 2 years]

Ocurrence of Knee replacement surgery [Time Frame: 2 years]

Acetaminophen Consumption [Time Frame: 2 years]

NSAIDs [Time Frame: 2 years]

OMERACT/OARSI 2004 response [Time Frame: 2 years]

Visual Analog Scale [Time Frame: 2 years]

Secondary ID(s)

NOVA-FCM-Rheuma-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centro de Estudos de Doenças Crónicas (CEDOC)

Hospital de Egas Moniz

Hospital de Santa Maria, Portugal

Instituto de Medicina Molecular

Nova Medical School (FCM-UNL)