Clinical trial NCT04045431: Treatment of Knee Osteoarthritis With PAAG-OA
Official title: A Multi-centre Randomized, Controlled, Double-blind Clinical Investigation of Intra-articular Polyacrylamide Hydrogel in Subjects With Knee Osteoarthritis Followed by an Open Label Extension Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Contura
Sponsor class: INDUSTRY
First posted: 2019-08-05
Enrollment: 238
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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
* 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 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
* 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

Primary outcomes:
measure: Comparing one injection of PAAG-OA with one injection of Synvisc-One on pain over 6 months in subjects with knee osteoarthritis
timeFrame: 6 months
Secondary outcomes:
measure: WOMAC
timeFrame: 1, 3, 6 and 12 months
measure: PGA (Patient Global Assessment)
timeFrame: 1, 3, 6 and 12 months
measure: EQ-5D-5L, QoL
timeFrame: 1, 3, 6 and 12 months
measure: OMERACT-OARSI responder criteria
timeFrame: 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute
city: Hillerød
country: Denmark
facility: A2 Reumatologi og idrætsmedicin
city: Odense
country: Denmark
facility: Reumatolog i Odense
Study officials:
affiliation: The Parker Institute
name: Henning Bliddal, MD
role: PRINCIPAL_INVESTIGATOR
References: