Status:
ACTIVE_NOT_RECRUITING
Treatment of Knee Osteoarthritis With PAAG-OA
Lead Sponsor:
Contura
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40+ years
Phase:
NA
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 s...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04045431
Start Date
May 15 2019
End Date
November 30 2026
Last Update
January 8 2024
Active Locations (3)
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1
The Parker Institute
Frederiksberg, Denmark
2
A2 Reumatologi og idrætsmedicin
Hillerød, Denmark
3
Reumatolog i Odense
Odense, Denmark