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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Nova Medical School (FCM-UNL)
Centro de Estudos de Doenças Crónicas
Hospital de Santa Maria, Portugal
Hospital de Egas Moniz
Instituto de Medicina Molecular João Lobo Antunes
Information provided by (Responsible Party):
Universidade Nova de Lisboa

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Of Knee Device: Intra-Articular Hyaluronic Acid Device: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 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
Device: Intra-Articular Hyaluronic Acid
Other Name: hylan GF-20

Placebo Comparator: Placebo

Saline solution:

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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Ocurrence of Knee replacement surgery [ Time Frame: 2 years ]
    Proportion of patients submitted to knee replacement surgery at the end of follow-up

  4. Acetaminophen Consumption [ Time Frame: 2 years ]
    Mean consumption of acetaminophen (mg/day) at each follow-up visit.

  5. NSAIDs [ Time Frame: 2 years ]
    Mean consumption of NSAIDs (mg/day) at each follow-up visit.

  6. SF-36 questionnaire - Physical Score [ Time Frame: 2 years ]
    Mean score of SF-36 questionnaire at each follow-up visit.

  7. SF-36 questionnaire - Mental Score [ Time Frame: 2 years ]
    Mean score of SF-36 questionnaire at each follow-up visit.

  8. Euro QoL 5D [ Time Frame: 2 years ]
    Mean score of Euro QoL 5D questionnaire at each follow-up visit.

  9. Adverse events [ Time Frame: 2 years ]
    Total number of adverse events occurring on both placebo and IAHA groups at each follow-up visit.

  10. Visual Analog Scale [ Time Frame: 2 years ]
    Mean VAS score at 2 years

  11. Visual Analog Scale [ Time Frame: 2 years ]
    Mean VAS score at each follow-up visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280538


Contacts
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Contact: Alexandre Sepriano, MD alexsepriano@gmail.com

Locations
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Portugal
Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz Recruiting
Lisbon, Portugal
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
Lisbon, Portugal
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         
Sponsors and Collaborators
Universidade Nova de Lisboa
Nova Medical School (FCM-UNL)
Centro de Estudos de Doenças Crónicas
Hospital de Santa Maria, Portugal
Hospital de Egas Moniz
Instituto de Medicina Molecular João Lobo Antunes
Investigators
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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
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Responsible Party: Universidade Nova de Lisboa
ClinicalTrials.gov Identifier: NCT02280538    
Other Study ID Numbers: NOVA-FCM-Rheuma-2
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014
Keywords provided by Universidade Nova de Lisboa:
Knee Osteoarthritis
Intra-Articular Hyaluronic Acid
disease modifying
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents