Treatment of Knee Osteoarthritis With PAAG-OA

NCT04045431 | Active Not Recruiting

• 1 other identifier: CON-OA-001
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• WOMAC

  1, 3, 6 and 12 months

• PGA (Patient Global Assessment)

  1, 3, 6 and 12 months

• EQ-5D-5L, QoL

  1, 3, 6 and 12 months

• OMERACT-OARSI responder criteria

  1, 3, 6 and 12 months

Study Arms (2)

PAAG-OA

EXPERIMENTAL

Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)

Device: PAAG-OA

Synvisc-One

ACTIVE COMPARATOR

Intra-articular injection with Synvisc-One (hyaluronic acid)

Device: Synvisc-One

Interventions

PAAG-OA DEVICE

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

PAAG-OA

Synvisc-One DEVICE

Intra-articular injection of 6ml Synvisc-One in the target knee

Synvisc-One

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Contura: lead

Study Sites (3)

The Parker Institute

Frederiksberg, Denmark

Location

A2 Reumatologi og idrætsmedicin

Hillerød, Denmark

Location

Reumatolog i Odense

Odense, Denmark

Location

Related Publications (1)

• Bliddal H, Beier J, Hartkopp A, Conaghan PG, Henriksen M. Three-year follow-up from a randomised controlled trial of a single intra-articular polyacrylamide hydrogel injection in subjects with knee osteoarthritis. Clin Exp Rheumatol. 2025 Dec 11. doi: 10.55563/clinexprheumatol/5lofry. Online ahead of print.

  PMID: 41487107 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Henning Bliddal, MD

  The Parker Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The subject and study staff will not know the treatment received. Only the unblinded injector will know the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: August 5, 2019
• Study Start: May 15, 2019
• Primary Completion: October 1, 2020
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

DK (3)