ROSA: Treatment of Knee Osteoarthritis With PAAG-OA
Study Details
Study Description
Brief Summary
This is a multi-center, randomized, double-blind clinical investigation to compare the effectiveness of intra-articular polyacrylamide hydrogel (PAAG-OA) and a hyaluronic acid, Synvisc-One to induce symptomatic benefit in subjects with knee osteoarthritis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PAAG-OA Intra-articular injection with PAAG-OA (polyacrylamide hydrogel) |
Device: PAAG-OA
Intra-articular injection of 6ml PAAG-OA in the target knee
|
| Active Comparator: Synvisc-One Intra-articular injection with Synvisc-One (hyaluronic acid) |
Device: Synvisc-One
Intra-articular injection of 6ml Synvisc-One in the target knee
|
Outcome Measures
Primary Outcome Measures
- Comparing one injection of PAAG-OA with one injection of Synvisc-One on pain over 6 months in subjects with knee osteoarthritis [6 months]
Change in WOMAC (WOMAC Osteoarthritis Index) pain subscale. Pain is reported in each of five response categories (0=none, 4=extreme)
Secondary Outcome Measures
- WOMAC [1, 3, 6 and 12 months]
WOMAC (WOMAC Osteoarthritis Index) self reported pain, stiffness and physical function, categories (0=none, 4=extreme)
- PGA (Patient Global Assessment) [1, 3, 6 and 12 months]
PGA reported on a 10 cm Visual Analogue Scale
- EQ-5D-5L, QoL [1, 3, 6 and 12 months]
EQ-5D-5L, Quality of Life, comprised of descriptive system where each dimension has 5 levels (ranging from no problems to extreme problems) and a 20 cm Visual Analogue Scale (0 = worst health and 100 = best health)
- OMERACT-OARSI responder criteria [1, 3, 6 and 12 months]
Per the OMERACT-OARSI criteria, a subject is classified as a positive responder if at least one (1) of the following two (2) conditions is observed at the post-baseline assessment: In either pain (WOMAC pain subscale) or function (WOMAC function subscale), a high improvement in the subscale, where high improvement in a subscale is achieved if there is both a > 50% improvement from Baseline and an absolute change from Baseline of > 20 normalised units (0-100 scale) OR Improvement in at least two (2) of the following three (3): Improvement in pain (WOMAC pain subscale) defined as > 20% improvement from Baseline and an absolute change from Baseline of > 10 (0-100 scale) Improvement in function (WOMAC function subscale) defined as > 20% improvement from Baseline and an absolute change from Baseline of > 10 (0-100 scale) Improvement in PGA defined as > 20% improvement from Baseline and an absolute change from Baseline of > 10 mm (0-100 sc
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed and dated informed consent form
-
Stated willingness to comply with all study procedures and availability for the duration of the study
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Male or female, aged ≥ 40 years
-
Clinical diagnosis of knee OA American College of Rheumatology criteria confirmed by radiology
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Definite radiographic OA in the most symptomatic knee (target knee) at mild to moderate-stage (Kellgren-Lawrence grades 2 or 3)
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Stable dose of analgesics for the past four weeks
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NRS (11 points (0-10) pain intensity numerical rating scale) ≥ 4 in target knee, during the past week when walking
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Body Mass Index (BMI) between 20-35
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For females of reproductive potential: use of adequate contraception must be used throughout the trial
Exclusion Criteria:
-
Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation
-
Contraindications to PAAG-OA or Synvisc-One®, according to IB or Instruction for Use (IFU)
-
Previous intra-articular injection of polyacrylamide gel in the target knee
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Previous intra-articular injection with hyaluronic acid or derivatives in target knee in the previous 6 months
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Significant valgus/varus deformity of the knee, ligamentous laxity or meniscal instability
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Other diseases in target knee than osteoarthritis
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Intra-articular injection of any substance other than hyaluronic acid (e.g. corticosteroids) in the target knee within the last 3 months
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Acute serious infection of any region that required hospital care or intravenous antibiotic treatment within the last 30 days, or oral antibiotic treatment within the last 14 days
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Skin disease or infections in the area of the injection site
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Infected or severely inflamed knees
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History of sepsis in any joint or any clinical concern for a subacute infectious process in the target knee
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History of surgery in the target knee within the past 6 months
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Symptomatic osteoarthritis of the hips, spine or ankle, that interferes with the evaluation of the target knee
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Planned surgery on any lower extremity
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Clinically significant venous or lymphatic stasis present in the legs
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Clinically apparent tense effusion or inflammation in the target knee
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Suffering from any unstable or severe cardio-vascular disease
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Any contraindication to intra-articular e.g. anticoagulant therapy or clinical concern for potential coagulopathy (e.g. liver disease)
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Any foreign material in the target joint
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Any significant medical condition (e.g. significant psychiatric or neurological disorders or active alcohol/drug abuse), any medical condition that is unstable/poorly controlled or other factors that may interfere with study participation
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Treatment with systemic steroids
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History of drug/alcohol abuse, mental dysfunction of other factors limiting their ability to cooperate fully
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Change in physiotherapy within the previous month
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Fibromyalgia
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Inflammatory or other disease/condition which may affect joints (e.g. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among others)
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Haemophilia
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Any other condition that in the opinion of the investigator put a potential participant at risk or otherwise precludes participation in the trial
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Known allergic reactions to components of Synvisc-One (avian protein)
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Known allergic reactions to antibiotics (azithromycin and moxifloxacin) or local anaesthesia
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Participation in any experimental device study within 6 months prior to enrolment, or participation in an experimental drug study within 1 month prior to enrolment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Parker Institute | Frederiksberg | Denmark | ||
| 2 | A2 Reumatologi og idrætsmedicin | Hillerød | Denmark | ||
| 3 | Reumatolog i Odense | Odense | Denmark |
Sponsors and Collaborators
- Contura
Investigators
- Principal Investigator: Henning Bliddal, MD, The Parker Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CON-OA-001