Osteoarthritis Of KneeViscOANCT02280538
Trial to Assess the Structural Effect and Long-term Symptomatic Relief of Intra-articular Injections of Hyaluronic Acid in Primary Knee OA
A study testing Intra-Articular Hyaluronic Acid in people with Osteoarthritis Of Knee, run by Universidade Nova de Lisboa at 2 sites in Portugal.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis Of Knee
- What is being tested?
- Intra-Articular Hyaluronic Acid
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesPortugal
- Study dates
- Apr 2014to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Alexandre Sepriano, MD contact
Portugal2 sites, 2 recruiting
- Recruiting
Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz
Lisbon, Lisbon District
Jaime Branco, MD, PhD, 00351 - 21 043 10 00
Jaime C Branco, MD, PhD
- Recruiting
Centro Hospitalar Lisboa Norte
Lisbon
Helena Canhão, MD, PhD, 00351 - 21 780 5000
Helena Canhão, MD,PhD
About this study
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
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.
Read the 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
- Being tested
- Intra-Articular Hyaluronic Acid, Placebo
- Keywords
- Knee Osteoarthritis, Intra-Articular Hyaluronic Acid, disease modifying
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Articular Hyaluronic AcidDevice
Also called hylan GF-20
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| Intra-Articular Hyaluronic Acid | Experimental | hylan G-F 20 (high molecular weight hyaluronic acid):
* intra-articular administration
* 6 mL
* administered every 6 months
* for 2 years Receives: Device: Intra-Articular Hyaluronic Acid |
| Placebo | Placebo comparator | Saline solution:
* intra-articular administration
* 6 mL
* administered every 6 months
* for 2 years Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (11)
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.
Measured: 6 months
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.
Measured: 2 years
Ocurrence of Knee replacement surgery
Proportion of patients submitted to knee replacement surgery at the end of follow-up
Measured: 2 years
Acetaminophen Consumption
Mean consumption of acetaminophen (mg/day) at each follow-up visit.
Measured: 2 years
NSAIDs
Mean consumption of NSAIDs (mg/day) at each follow-up visit.
Measured: 2 years
SF-36 questionnaire - Physical Score
Mean score of SF-36 questionnaire at each follow-up visit.
Measured: 2 years
SF-36 questionnaire - Mental Score
Mean score of SF-36 questionnaire at each follow-up visit.
Measured: 2 years
Euro QoL 5D
Mean score of Euro QoL 5D questionnaire at each follow-up visit.
Measured: 2 years
Adverse events
Total number of adverse events occurring on both placebo and IAHA groups at each follow-up visit.
Measured: 2 years
Visual Analog Scale
Mean VAS score at 2 years
Measured: 2 years
Visual Analog Scale
Mean VAS score at each follow-up visit.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis Of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- NOVA Medical School, Centro de Estudos de Doenças Crónicas, Hospital de Santa Maria, Portugal, Hospital de Egas Moniz, Instituto de Medicina Molecular João Lobo Antunes
- Responsible party
- Sponsor
- Investigators
- Jaime C Branco, MD, PhD, Principal investigator, CEDOCAlexandre Sepriano, MD, Study director, Centro Hospitalar de Lisboa OcidentalJoão Gomes, MD, Study chair, Centro Hospitalar de Lisboa Ocidental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280538
- Sponsor's protocol ID
- NOVA-FCM-Rheuma-2
- Acronym
- ViscOA
- Status last verified
- Oct 2014
- First submitted
- 29 Oct 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02280538
- Acronym / sponsor ID
- ViscOA / NOVA-FCM-Rheuma-2
- Conditions
- Osteoarthritis Of Knee
- Keywords
- Knee Osteoarthritis, Intra-Articular Hyaluronic Acid, disease modifying
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- NOVA Medical School, Centro de Estudos de Doenças Crónicas, Hospital de Santa Maria, Portugal, Hospital de Egas Moniz, Instituto de Medicina Molecular João Lobo Antunes
- Study start
- Apr 2014
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-Articular Hyaluronic Acid | Experimental | Device: Intra-Articular Hyaluronic Acidhylan G-F 20 (high molecular weight hyaluronic acid): * intra-articular administration * 6 mL * administered every 6 months * for 2 years |
| Placebo | Placebo comparator | Device: PlaceboSaline solution: * intra-articular administration * 6 mL * administered every 6 months * for 2 years |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-Articular Hyaluronic AcidAlso: hylan GF-20 | Device | Intra-Articular Hyaluronic Acid |
| Placebo | Device | Placebo |
Primary outcome
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).
11 secondary outcomes
OMERACT/OARSI 2004 response
Time frame: 6 months
OMERACT/OARSI 2004 response
Time frame: 2 years
Ocurrence of Knee replacement surgery
Time frame: 2 years
Acetaminophen Consumption
Time frame: 2 years
NSAIDs
Time frame: 2 years
SF-36 questionnaire - Physical Score
Time frame: 2 years
SF-36 questionnaire - Mental Score
Time frame: 2 years
Euro QoL 5D
Time frame: 2 years
Adverse events
Time frame: 2 years
Visual Analog Scale
Time frame: 2 years
Visual Analog Scale
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Sepriano, MD contact
Jaime C Branco, MD, PhD principal investigator
CEDOC
Alexandre Sepriano, MD study director
Centro Hospitalar de Lisboa Ocidental
João Gomes, MD study chair
Centro Hospitalar de Lisboa Ocidental
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Articular Hyaluronic Acid in people with Osteoarthritis Of Knee, run by Universidade Nova de Lisboa at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Sepriano, MD (alexsepriano@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint Space Width (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2014.