Trial to Assess the Structural Effect and Long-term Symptomatic Relief of Intra-articular Injections of Hyaluronic Acid in Primary Knee OA (ViscOA)
|ClinicalTrials.gov Identifier: NCT02280538|
Recruitment Status : Unknown
Verified October 2014 by Universidade Nova de Lisboa.
Recruitment status was: Recruiting
First Posted : October 31, 2014
Last Update Posted : November 3, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Of Knee||Device: Intra-Articular Hyaluronic Acid Device: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
Experimental: Intra-Articular Hyaluronic Acid
hylan G-F 20 (high molecular weight hyaluronic acid):
Device: Intra-Articular Hyaluronic Acid
Other Name: hylan GF-20
Placebo Comparator: Placebo
- Joint Space Width [ Time Frame: 2 years ]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).
- OMERACT/OARSI 2004 response [ Time Frame: 6 months ]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.
- OMERACT/OARSI 2004 response [ Time Frame: 2 years ]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.
- Ocurrence of Knee replacement surgery [ Time Frame: 2 years ]Proportion of patients submitted to knee replacement surgery at the end of follow-up
- Acetaminophen Consumption [ Time Frame: 2 years ]Mean consumption of acetaminophen (mg/day) at each follow-up visit.
- NSAIDs [ Time Frame: 2 years ]Mean consumption of NSAIDs (mg/day) at each follow-up visit.
- SF-36 questionnaire - Physical Score [ Time Frame: 2 years ]Mean score of SF-36 questionnaire at each follow-up visit.
- SF-36 questionnaire - Mental Score [ Time Frame: 2 years ]Mean score of SF-36 questionnaire at each follow-up visit.
- Euro QoL 5D [ Time Frame: 2 years ]Mean score of Euro QoL 5D questionnaire at each follow-up visit.
- Adverse events [ Time Frame: 2 years ]Total number of adverse events occurring on both placebo and IAHA groups at each follow-up visit.
- Visual Analog Scale [ Time Frame: 2 years ]Mean VAS score at 2 years
- Visual Analog Scale [ Time Frame: 2 years ]Mean VAS score at each follow-up visit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280538
|Contact: Alexandre Sepriano, MDfirstname.lastname@example.org|
|Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz||Recruiting|
|Contact: Jaime Branco, MD, PhD 00351 - 21 043 10 00|
|Principal Investigator: Jaime C Branco, MD, PhD|
|Sub-Investigator: Fernando Pimentel-Santos, MD, PhD|
|Sub-Investigator: Alexandre Sepriano, MD|
|Sub-Investigator: João L Gomes, MD|
|Sub-Investigator: Teresa Pedrosa, MD|
|Sub-Investigator: Sofia Serra, MD|
|Sub-Investigator: Sandra Falcão, MD|
|Centro Hospitalar Lisboa Norte||Recruiting|
|Contact: Helena Canhão, MD, PhD 00351 - 21 780 5000|
|Principal Investigator: Helena Canhão, MD,PhD|
|Sub-Investigator: Maria João Gonçalves, MD|
|Sub-Investigator: Vasco Romão, MD|
|Sub-Investigator: Nikita Khmelinskii, MD|
|Sub-Investigator: Sílvia Silva, MD|
|Sub-Investigator: Joaquim Polido-Pereira, MD|
|Sub-Investigator: Alice Morais Castro, MD|
|Sub-Investigator: Fernando Saraiva, MD|
|Principal Investigator:||Jaime C Branco, MD, PhD||CEDOC|
|Study Director:||Alexandre Sepriano, MD||Centro Hospitalar de Lisboa Ocidental|
|Study Chair:||João Gomes, MD||Centro Hospitalar de Lisboa Ocidental|