PAAG-OA Treatment for Knee Osteoarthritis

NCT04179552 | Completed

• 1 other identifier: CON-OA
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multi-centre, prospective, open-label, uncontrolled, clinical investigation followed by an open-label extension clinical investigation to evaluate PAAG-OA in patients with knee osteoarthritis.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (3)

• Change in the WOMAC pain subscale

  To evaluate the effectiveness of one injection of PAAG-OA on pain over 3 months in subjects with mild to severe knee OA. Change in WOMAC (WOMAC Osteoarthritis Index) pain subscale where a score of 0=none, and 4=extreme

  3 months

• WOMAC

  To evaluate the effectiveness of one injection of PAAG-OA on knee OA-related subject reported symptoms, function during activities of daily living. Change in WOMAC (WOMAC Osteoarthritis Index) pain subscale where a score of 0=none, and 4=extreme

  1 and 3 months

• PGA

  To evaluate the effectiveness of one injection of PAAG-OA on knee OA Patient Global Assessment (PGA). PGA is reported on a 10 cm Visual Analogue Scale

  1 and 3 months

Secondary Outcomes (2)

• Change in WOMAC

  6 and 12 months

• Change in PGA

  6 and 12 months

Study Arms (1)

PAAG-OA

EXPERIMENTAL

All subjects receive treatment with PAAG-OA

Device: PAAG-OA

Interventions

PAAG-OA DEVICE

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

PAAG-OA

Eligibility Criteria

• Age: 18 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 ≥ 18 years
• Clinical diagnosis of knee OA according to American College of Rheumatology criteria
• Definite radiographic OA in target knee at mild to severe stage (Kellgren-Lawrence 2-4)
• Stable dose of analgesics for the past four weeks
• Score of 2 or more (0-4 scale) on WOMAC question A1 (pain while walking on flat surface)
• Body Mass Index (BMI) \<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
• 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
• Diseases in target knee other than OA
• 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
• History of sepsis in any joint or any clinical concern for an 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 of lymphatic stasis present in the legs
• Suffering from any unstable or severe cardio-vascular disease
• Any other contraindication to intra-articular injection

Sponsors & Collaborators

• Contura: lead

Study Sites (3)

The Parker Institute

Frederiksberg, 2000, Denmark

Location

A2 Reumatologi og Idrætsmedicin

Hillerød, Denmark

Location

Reumatolog i Odense

Odense, Denmark

Location

Related Publications (2)

• Bliddal H, Hartkopp A, Beier J, Conaghan PG, Henriksen M. A prospective, open-label, clinical investigation of a single intra-articular polyacrylamide hydrogel injection in participants with knee osteoarthritis: a 5-year extension study. J Orthop Surg Res. 2025 Dec 12. doi: 10.1186/s13018-025-06526-0. Online ahead of print.

  PMID: 41387884 DERIVED

• Bliddal H, Beier J, Hartkopp A, Conaghan PG, Henriksen M. Effectiveness and safety of polyacrylamide hydrogel injection for knee osteoarthritis: results from a 12-month follow up of an open-label study. J Orthop Surg Res. 2024 May 2;19(1):274. doi: 10.1186/s13018-024-04756-2.

  PMID: 38698396 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 27, 2019
• Study Start: August 21, 2019
• Primary Completion: February 7, 2020
• Study Completion: September 19, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

DK (3)