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

Osteoarthritis Of Knee Clinical Trial

— ViscOA  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02280538
• Other study ID #: NOVA-FCM-Rheuma-2
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2014
• Last updated: October 31, 2014
• Start date: April 2014
• Est. completion date: January 2018

Study information

• Verified date: October 2014
• Source: Universidade Nova de Lisboa
• Contact: Alexandre Sepriano, MD
• Email: alexsepriano[@]gmail.com
• Is FDA regulated: No
• Health authority: Portugal: INFARMED, National Authority of Medicines and Health Products, IP
• Study type: Interventional

Clinical Trial Summary

The present study is designed to test the hypothesis that Intra-Articular Hyaluronic Acid (IAHA) is superior to placebo in slowing structural progression and on long term symptomatic effect in primary knee Osteoarthritis (OA) patients.

The investigators will perform a multicenter double-blind, randomized, placebo-controlled, parallel group trial.

Description:

The target population will be patients with the diagnosis of knee osteoarthritis who are followed at two Portuguese hospitals (Centro Hospitalar de Lisboa Norte - Hospital Santa Maria, Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz).

All patients selected will be included in the intention-to-treat group. Then, using blocked randomization method they will be assigned to receive either IAHA, or placebo (saline solution). At both hospitals the study will consist of four injections of IAHA, 6 months apart, plus a 6 month period after the injection, resulting in a total follow-up period of 24 months. Before each new cycle a follow-up consultation will be performed in order to assess pain and function (KOOS), quality of life (SF-36), adverse events and consumption of acetaminophen and NSAIDS regarding the week before evaluation. X-rays will be performed in the beginning of follow-up, one year after that and 6 months after the last cycle of IAHA or placebo injections (24 months).

Ultrasound evaluation will be performed at the target knee in same time points as X-rays by two rheumatologists trained in musculoskeletal ultrasound examination. Additionally, the investigators will assess potential biochemical biomarkers of knee OA structural progression and response to treatment. Measurements will be performed in both serum and urine and, If possible, synovial fluid aspiration will be performed and together with blood and urine samples stored at the Biobanco-IMM Instituto de Medicina Molecular for analysis. Biologic samples collection will be performed at baseline and repeated at the 4th, 12th, 24th, 36th weeks, and then every 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Of Knee
• Osteoarthritis, Knee

Intervention

Device:
• Intra-Articular Hyaluronic Acid

• Placebo

Locations

Country	Name	City	State
Portugal	Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz	Lisbon
Portugal	Centro Hospitalar Lisboa Norte	Lisbon

Sponsors (6)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa	Centro de Estudos de Doenças Crónicas, Hospital de Egas Moniz, Hospital de Santa Maria, Portugal, Instituto de Medicina Molecular, Nova Medical School (FCM-UNL)

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint Space Width	Mean change of minimal JSW of the most affected compartment of the tibiofemural joint in both placebo and IAHA groups at the end of follow-up (2 years).	2 years	No
Secondary	OMERACT/OARSI 2004 response	Proportion of patients achieving symptomatic relief according to OMERACT/OARSI 2004 response criteria at 6 months of follow-up in both placebo and IAHA groups. OMERACT/OARSI 2004 will be determined using KOOS questionnaire.	6 months	No
Secondary	OMERACT/OARSI 2004 response	Proportion of patients achieving symptomatic relief according to OMERACT/OARSI 2004 criteria at each follow-up visit. OMERACT/OARSI 2004 will be determined using KOOS questionnaire.	2 years	No
Secondary	Ocurrence of Knee replacement surgery	Proportion of patients submitted to knee replacement surgery at the end of follow-up	2 years	No
Secondary	Acetaminophen Consumption	Mean consumption of acetaminophen (mg/day) at each follow-up visit.	2 years	No
Secondary	NSAIDs	Mean consumption of NSAIDs (mg/day) at each follow-up visit.	2 years	No
Secondary	SF-36 questionnaire - Physical Score	Mean score of SF-36 questionnaire at each follow-up visit.	2 years	No
Secondary	SF-36 questionnaire - Mental Score	Mean score of SF-36 questionnaire at each follow-up visit.	2 years	No
Secondary	Euro QoL 5D	Mean score of Euro QoL 5D questionnaire at each follow-up visit.	2 years	No
Secondary	Adverse events	Total number of adverse events occurring on both placebo and IAHA groups at each follow-up visit.	2 years	Yes
Secondary	Visual Analog Scale	Mean VAS score at 2 years	2 years	No
Secondary	Visual Analog Scale	Mean VAS score at each follow-up visit.	2 years	No