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

NCT ID: NCT02280538

Last Updated: 2014-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-01-31

Brief 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.

Detailed 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.

Conditions

Osteoarthritis Of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intra-Articular Hyaluronic Acid

hylan G-F 20 (high molecular weight hyaluronic acid):

• intra-articular administration
• 6 mL
• administered every 6 months
• for 2 years

Group Type: EXPERIMENTAL

Intra-Articular Hyaluronic Acid

Intervention Type: DEVICE

Placebo

Saline solution:

• intra-articular administration
• 6 mL
• administered every 6 months
• for 2 years

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Interventions

Intra-Articular Hyaluronic Acid

Intervention Type: DEVICE

Placebo

Intervention Type: DEVICE

Other Intervention Names

hylan GF-20

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NOVA Medical School

OTHER

Sponsor Role: collaborator

Centro de Estudos de Doenças Crónicas

OTHER

Sponsor Role: collaborator

Hospital de Santa Maria, Portugal

OTHER

Sponsor Role: collaborator

Hospital de Egas Moniz

OTHER

Sponsor Role: collaborator

Instituto de Medicina Molecular João Lobo Antunes

OTHER

Sponsor Role: collaborator

Universidade Nova de Lisboa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaime C Branco, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CEDOC

Alexandre Sepriano, MD

Role: STUDY_DIRECTOR

Centro Hospitalar de Lisboa Ocidental

João Gomes, MD

Role: STUDY_CHAIR

Centro Hospitalar de Lisboa Ocidental

Locations

Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz

Lisbon, Lisbon District, Portugal

Site Status: RECRUITING

Centro Hospitalar Lisboa Norte

Lisbon, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Alexandre Sepriano, MD

Role: CONTACT

alexsepriano@gmail.com

Facility Contacts

Jaime Branco, MD, PhD

Role: primary

00351 - 21 043 10 00

Helena Canhão, MD, PhD

Role: primary

00351 - 21 780 5000

Other Identifiers

NOVA-FCM-Rheuma-2

Identifier Type: -

Identifier Source: org_study_id