Status:
UNKNOWN
Trial to Assess the Structural Effect and Long-term Symptomatic Relief of Intra-articular Injections of Hyaluronic Acid in Primary Knee OA
Lead Sponsor:
Universidade Nova de Lisboa
Collaborating Sponsors:
NOVA Medical School
Centro de Estudos de Doenças Crónicas
Conditions:
Osteoarthritis Of Knee
Eligibility:
All Genders
50+ years
Phase:
NA
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...
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 Hospital...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02280538
Start Date
April 1 2014
End Date
January 1 2018
Last Update
November 3 2014
Active Locations (2)
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1
Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz
Lisbon, Lisbon District, Portugal
2
Centro Hospitalar Lisboa Norte
Lisbon, Portugal