ArticleClinical medicine insights. Arthritis and musculoskeletal disorders2018
A Pooled Analysis of Two Multicenter, Randomized Controlled Trials of a Single Intra-articular Injection of Gel-200 for Treatment of Osteoarthritis of the Knee.
Article in Clinical medicine insights. Arthritis and musculoskeletal disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-Center, Randomized, Double-Blind, Controlled, Parallel-Group Study of a Single Intra-Articular Injection of Gel-200 With a Single Intra-Articular Injection of Phosphate Buffered Saline (PBS) in Osteoarthritis of the Knee.
A Multi-Center Extension and Open-Label Study of a Single or Repeat Intra-Articular Injection of Gel-200 in Osteoarthritis of the Knee.
Who cites it
3 citing papers in PubMed, 4 citations in OpenAlex.
- Recent Developments in Hyaluronic Acid-Based Hydrogels for Cartilage Tissue Engineering Applications.Polymers · 2022Review
- Intraarticular Hyaluronic Acid Preparations for Knee Osteoarthritis: Are Some Better Than Others?Cartilage · 2021Review
- Autologous Mesenchymal Stem Cell Treatment is Consistently Effective for the Treatment of Knee Osteoarthritis: The Results of a Systematic Review of Treatment and Comparison to a Placebo Group.Medicines (Basel, Switzerland) · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveTo perform an integrated analysis of 2 randomized controlled trials (RCTs) to assess the efficacy and safety of a single intra-articular injection of Gel-200 compared with phosphate buffered saline (PBS) for treatment of osteoarthritis of the knee.
methodsData from the intention-to-treat (ITT) populations of both RCTs were pooled for this integrated analysis. Mean changes from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscores were assessed using a longitudinal model; treatment differences were compared between intra-articular Gel-200 and PBS injections. Analyses included secondary outcome measures repeated at individual time points. The safety populations of both RCTs were pooled for an integrated safety analysis to compare adverse events (AEs).
resultsThe pooled ITT population included 1184 subjects (649 Gel-200; 535 PBS); demographic characteristics were similar between treatment groups. Mean improvements in pain subscores from baseline to week 12 were -24.7 mm in Gel-200 and -21.8 mm in PBS groups, a statistically significant treatment group difference of -2.9 mm (
conclusionThis integrated analysis demonstrated the efficacy of a single intra-articular injection of Gel-200 compared with PBS for treatment of osteoarthritis of the knee over 26 weeks without major safety concerns.
trial registrationNCT00449696 and NCT00450112.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.