At a glance
ClinicalIndex Comparison RecordN/ACompleted· 144 enrolled
Drug / intervention
hydrous biopolymer with silver ions "Argiform" +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Double-blind Randomized Comparative Placebo-controlled Study of Efficacy and Safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid (NOLTREX™) in Knee Osteoarthritis
In Brief
A clinical study evaluating hydrous biopolymer with silver ions "Argiform" and saline solution for Osteoarthritis. Completed, enrolled 144 participants across 4 sites.
Detailed Summary
The aim of this double-blinded controlled study is to assess clinical efficacy and safety of intra-articular HBISA Endoprosthesis of Synovial Fluid (polyacrylamide hydrogel) in comparison with placebo (0.9% sodium chloride solution) in Kellgren Lawrence radiological grade II-III knee osteoarthritis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesRussia
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartNov 2019
Primary CompletionJun 2020
Study CompletionDec 2020
TodayJul 2026
First PostedApr 1, 2019
Enrollment StartNov 29, 2019
Primary CompletionJun 2, 2020
Study CompletionDec 17, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.3 years ago
Interventions
hydrous biopolymer with silver ions "Argiform"device
2 once-weekly intra-articular injections of NOLTREX™ 4.0 ml
saline solutiondevice
2 once-weekly intra-articular injections of saline solution 4 ml