Intra-articular Polyacrylamide Hydrogel in the Treatment of Knee Osteoarthritis

Bioform

Status: Completed

Conditions: Osteoarthritis, Knee

Study type: Observational

Funder types: Industry

Identifiers

NCT06523491

IA/PAAG-SI/OA/2023

Details and patient eligibility

About

1-year follow-up of a randomized controlled trial with open-label extension to assess the long-term efficacy and safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis.

Full description

HBISA (polyacrylamide hydrogel) endoprosthesis of synovial fluid NOLTREX™ is intended for the symptomatic treatment of adult patients with osteoarthritis (OA) reducing pain and improving mobility.

The aim of this 1-year follow-up was to evaluate the long-term safety and efficacy of IA Polyacrylamide hydrogel with silver ions in patients with Kellgren-Lawrence grade 3 and 4 knee osteoarthritis who had received one or two treatment courses in the IA/PAAG-SI/OA/2019 and IA/PAAG-SI/OA/2020 studies.

Follow-up data were collected in telephone interviewing (using questionnaire) in April-July 2022, 12 months after the completion of OLE (IA/PAAG-SI/OA/2020).

Enrollment: 57 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The study included patients with KL grade 2-3 knee osteoarthritis who had completed study IA/PAAG-SI/OA/2019 and IA/PAAG-SI/OA/2020.

Exclusion criteria

Declining participation in the survey Lost to follow-up

Trial design

57 participants in 3 patient groups

Group NOLTREX 2 courses

Description:

Group NOLTREX 2 courses consisted of 30 patients who had received 2 NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020)

Group NOLTREX 1 course

Description:

Group NOLTREX 1 course comprised 17 patients who received 1 NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019)

Placebo group

Description:

Placebo group consisted of 10 patients who had received placebo in the parent study IA/PAAG-SI/OA/2019 and had not taken part in OLE. Of 72 patients approached, only 10 agreed to participate and completed the survey.