Treatment of Knee Osteoarthritis With PAAG-OA
- Conditions
- Osteoarthritis, Knee
- Interventions
- Device: PAAG-OADevice: Synvisc-One
- Registration Number
- NCT04045431
- Lead Sponsor
- Contura
- 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.
- Detailed Description
The trial is designed as a multi-center, randomised, controlled, double-blind, and parallel-group trial spanning over 12 months with outcome assessments at baseline, 1, 3, 6 and 12 months incl. follow-up period between 2-5 years. Primary endpoint at 6 months. The trial is designed to compare effectiveness and safety of injection of PAAG-OA and Synvisc-One® in participants with knee OA.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 238
- Signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 40 years
- Clinical diagnosis of knee OA American College of Rheumatology criteria confirmed by radiology
- Definite radiographic OA in the most symptomatic knee (target knee) at mild to moderate-stage (Kellgren-Lawrence grades 2 or 3)
- Stable dose of analgesics for the past four weeks
- NRS (11 points (0-10) pain intensity numerical rating scale) ≥ 4 in target knee, during the past week when walking
- Body Mass Index (BMI) between 20-35
- For females of reproductive potential: use of adequate contraception must be used throughout the trial
- 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
- Previous intra-articular injection with hyaluronic acid or derivatives in target knee in the previous 6 months
- Significant valgus/varus deformity of the knee, ligamentous laxity or meniscal instability
- Other diseases in target knee than osteoarthritis
- Intra-articular injection of any substance other than hyaluronic acid (e.g. corticosteroids) in the target knee within the last 3 months
- 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
- Skin disease or infections in the area of the injection site
- Infected or severely inflamed knees
- History of sepsis in any joint or any clinical concern for a subacute infectious process in the target knee
- History of surgery in the target knee within the past 6 months
- Symptomatic osteoarthritis of the hips, spine or ankle, that interferes with the evaluation of the target knee
- Planned surgery on any lower extremity
- Clinically significant venous or lymphatic stasis present in the legs
- Clinically apparent tense effusion or inflammation in the target knee
- Suffering from any unstable or severe cardio-vascular disease
- Any contraindication to intra-articular e.g. anticoagulant therapy or clinical concern for potential coagulopathy (e.g. liver disease)
- Any foreign material in the target joint
- 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
- Treatment with systemic steroids
- History of drug/alcohol abuse, mental dysfunction of other factors limiting their ability to cooperate fully
- Change in physiotherapy within the previous month
- Fibromyalgia
- Inflammatory or other disease/condition which may affect joints (e.g. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among others)
- Haemophilia
- Any other condition that in the opinion of the investigator put a potential participant at risk or otherwise precludes participation in the trial
- Known allergic reactions to components of Synvisc-One (avian protein)
- Known allergic reactions to antibiotics (azithromycin and moxifloxacin) or local anaesthesia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PAAG-OA PAAG-OA Intra-articular injection with PAAG-OA (polyacrylamide hydrogel) Synvisc-One Synvisc-One Intra-articular injection with Synvisc-One (hyaluronic acid)
- Primary Outcome Measures
Name Time Method 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
Name Time Method PGA (Patient Global Assessment) 1, 3, 6 and 12 months PGA reported on a 10 cm Visual Analogue Scale
WOMAC 1, 3, 6 and 12 months WOMAC (WOMAC Osteoarthritis Index) self reported pain, stiffness and physical function, categories (0=none, 4=extreme)
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):
1. Improvement in pain (WOMAC pain subscale) defined as \> 20% improvement from Baseline and an absolute change from Baseline of \> 10 (0-100 scale)
2. Improvement in function (WOMAC function subscale) defined as \> 20% improvement from Baseline and an absolute change from Baseline of \> 10 (0-100 scale)
3. Improvement in PGA defined as \> 20% improvement from Baseline and an absolute change from Baseline of \> 10 mm (0-100 sc
Trial Locations
- Locations (3)
A2 Reumatologi og idrætsmedicin
🇩🇰Hillerød, Denmark
Reumatolog i Odense
🇩🇰Odense, Denmark
The Parker Institute
🇩🇰Frederiksberg, Denmark