PAAG-OA Treatment for Knee Osteoarthritis

NCT ID: NCT04179552

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-21
• Study Completion Date: 2024-09-19

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.

Detailed Description

This is a multi-centre, prospective, open-label clinical trial consisting of a main study followed by an extension study. The study will evaluate the effectiveness and safety of intra-articular polyacrylamide hydrogel (PAAG-OA) in subjects with knee OA.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PAAG-OA

All subjects receive treatment with PAAG-OA

Group Type: EXPERIMENTAL

PAAG-OA

Intervention Type: DEVICE

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

Interventions

PAAG-OA

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged ≥ 18 years

4. Clinical diagnosis of knee OA according to American College of Rheumatology criteria

5. Definite radiographic OA in target knee at mild to severe stage (Kellgren-Lawrence 2-4)

6. Stable dose of analgesics for the past four weeks

7. Score of 2 or more (0-4 scale) on WOMAC question A1 (pain while walking on flat surface)

8. Body Mass Index (BMI) <35

9. For females of reproductive potential: use of adequate contraception must be used throughout the trial

Exclusion Criteria

1. Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation

2. Previous intra-articular injection of polyacrylamide gel in the target knee

3. Previous intra-articular injection with hyaluronic acid or derivatives in target knee in the previous 6 months

4. Significant valgus/varus deformity of the knee, ligamentous laxity or meniscal instability

5. Diseases in target knee other than OA

6. Intra-articular injection of any substance other than hyaluronic acid (e.g. corticosteroids) in the target knee within the last 3 months

7. 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

8. Skin disease or infections in the area of the injection site

9. History of sepsis in any joint or any clinical concern for an infectious process in the target knee

10. History of surgery in the target knee within the past 6 months

11. Symptomatic osteoarthritis of the hips, spine or ankle, that interferes with the evaluation of the target knee

12. Planned surgery on any lower extremity

13. Clinically significant venous of lymphatic stasis present in the legs

14. Suffering from any unstable or severe cardio-vascular disease

15. Any other contraindication to intra-articular injection

16. Any foreign material in the target joint

17. Any significant medical condition (e.g. significant psychiatric or neurological disorders or active alcohol/drug abuse) that is unstable/poorly controlled or other factors that may interfere with study participation

18. Treatment with systemic steroids with daily doses equivalent of >7,5 mg prednisolone

19. Significant change in physiotherapy in lower extremities related to OA within the previous month

20. Fibromyalgia

21. Inflammatory or other disease/condition which may affect the knee joint (e.g. rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among others)

22. Haemophilia

23. Any other condition that in the opinion of the investigator puts a potential participant at risk or otherwise precludes participation in the investigation

24. Known allergic reactions to antibiotics (azithromycin and moxifloxacin) or local anaesthesia

25. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Contura

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henning Bliddal, MD

Role: PRINCIPAL_INVESTIGATOR

The Parker Institute

Locations

The Parker Institute

Frederiksberg, , Denmark

A2 Reumatologi og Idrætsmedicin

Hillerød, , Denmark

Reumatolog i Odense

Odense, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 38698396 (View on PubMed)

Other Identifiers

CON-OA

Identifier Type: -

Identifier Source: org_study_id