Treatment of Knee Osteoarthritis With PAAG-OA

Osteoarthritis, Knee Clinical Trial

— ROSA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04045431
• Other study ID #: CON-OA-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: November 30, 2026

Study information

• Verified date: January 2024
• Source: Contura
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 238
• Est. completion date: November 30, 2026
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• PAAG-OA
Intra-articular injection of 6ml PAAG-OA in the target knee (incl. five (5) years follow-up) period.
• Synvisc-One
Intra-articular injection of 6ml Synvisc-One in the target knee

Locations

Country	Name	City	State
Denmark	The Parker Institute	Frederiksberg
Denmark	A2 Reumatologi og idrætsmedicin	Hillerød
Denmark	Reumatolog i Odense	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Contura

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing one injection of PAAG-OA with one injection of Synvisc-One on pain over 6 months in subjects with knee osteoarthritis	Change in WOMAC (WOMAC Osteoarthritis Index) pain subscale. Pain is reported in each of five response categories (0=none, 4=extreme)	6 months
Secondary	WOMAC	WOMAC (WOMAC Osteoarthritis Index) self reported pain, stiffness and physical function, categories (0=none, 4=extreme)	1, 3, 6 and 12 months
Secondary	PGA (Patient Global Assessment)	PGA reported on a 10 cm Visual Analogue Scale	1, 3, 6 and 12 months
Secondary	EQ-5D-5L, QoL	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)	1, 3, 6 and 12 months
Secondary	OMERACT-OARSI responder criteria	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	1, 3, 6 and 12 months