Trial reportBMC musculoskeletal disorders2016
Structural effects of sprifermin in knee osteoarthritis: a post-hoc analysis on cartilage and non-cartilaginous tissue alterations in a randomized controlled trial.
Trial report in BMC musculoskeletal disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01033994 (A Randomized, Double Blind, Placebo-controlled, Multicenter, Single and Multiple Ascending Dose Study of AS902330), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 Randomized, Double Blind, Placebo-controlled, Multicenter, Single and Multiple Ascending Dose Study of AS902330 (rhFGF-18) Administered Intra-articularly in Patients With Primary Osteoarthritis of the Knee Who Are Not Expected to Require Knee Surgery Within One Year
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.
- Efficacy and safety of sprifermin injection for knee osteoarthritis treatment: a meta-analysis.Arthritis research & therapy · 2021Pooled it
- Clinical validation of fully automated (peri-)articular tissue analysis for assessing osteoarthritis progression: A narrative review.Osteoarthritis and cartilage open · 2026Review
- Emerging concepts and challenges in the development of disease-modifying osteoarthritis drugs - a more refined perspective.Archives of pharmacal research · 2025Review
- Bone marrow lesions in osteoarthritis: biomarker or treatment target? A narrative review.Skeletal radiology · 2025Review
- Bioactive peptides and proteins for tissue repair: microenvironment modulation, rational delivery, and clinical potential.Military Medical Research · 2024Review
- Approaches to optimize analyses of multidimensional ordinal MRI data in osteoarthritis research: A perspective.Osteoarthritis and cartilage open · 2024Article
- Association of AI-determined Kellgren-Lawrence grade with medial meniscus extrusion and cartilage thickness by AI-based 3D MRI analysis in early knee osteoarthritis.Scientific reports · 2023Article
- Strategic application of imaging in DMOAD clinical trials: focus on eligibility, drug delivery, and semiquantitative assessment of structural progression.Therapeutic advances in musculoskeletal disease · 2023Review
- How Effective Are Non-Operative Intra-Articular Treatments for Bone Marrow Lesions in Knee Osteoarthritis in Adults? A Systematic Review of Controlled Clinical Trials.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Repurposed and investigational disease-modifying drugs in osteoarthritis (DMOADs).Therapeutic advances in musculoskeletal disease · 2022Review
- Cross-sectional and longitudinal reliability of semiquantitative osteoarthritis assessment at 1.0T extremity MRI: Multi-reader data from the MOST study.Osteoarthritis and cartilage open · 2021Article
- Quantitative and Comparative Analysis of Effectivity and Robustness for Enhanced and Optimized Non-Local Mean Filter Combining Pixel and Patch Information on MR Images of Musculoskeletal System.Sensors (Basel, Switzerland) · 2021Article
- From Pathogenesis to Therapy in Knee Osteoarthritis: Bench-to-Bedside.International journal of molecular sciences · 2021Review
- Sprifermin: Effects on Cartilage Homeostasis and Therapeutic Prospects in Cartilage-Related Diseases.Frontiers in cell and developmental biology · 2021Review
- The Development of Disease-Modifying Therapies for Osteoarthritis (DMOADs): The Evidence to Date.Drug design, development and therapy · 2021Review
- New Trends in Pharmacological Treatments for Osteoarthritis.Frontiers in pharmacology · 2021Review
- Emerging pharmaceutical therapies for osteoarthritis.Nature reviews. Rheumatology · 2020Review
- Fibrin-Hyaluronic Acid Hydrogel (RegenoGel) with Fibroblast Growth Factor-18 for In Vitro 3D Culture of Human and Bovine Nucleus Pulposus Cells.International journal of molecular sciences · 2019Article
- Intra-articular treatment options for knee osteoarthritis.Nature reviews. Rheumatology · 2019Review
- Sprifermin treatment enhances cartilage integration in an in vitro repair model.Journal of orthopaedic research : official publication of the Orthopaedic Research Society · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA recent publication on efficacy of Sprifermin for knee osteoarthritis (OA) using quantitatively MRI-defined central medial tibio-femoral compartment cartilage thickness as the structural primary endpoint reported no statistically significant dose response. However, Sprifermin was associated with statistically significant, dose-dependent reductions in loss of total and lateral tibio-femoral cartilage thickness. Based on these preliminary promising data a post-hoc analysis of secondary assessment and endpoints was performed to evaluate potential effects of Sprifermin on semi-quantitatively evaluated structural MRI parameters. Aim of the present analysis was to determine effects of sprifermin on several knee joint tissues over a 12 month period.
methods1.5 T or 3 T MRIs were acquired at baseline and 12 months follow-up using a standard protocol. MRIs were read according to the Whole-Organ Magnetic Resonance Imaging Score (WORMS) scoring system (in 14 articular subregions) by four muskuloskeletal radiologists independently. Analyses focused on semiquantitative changes in the 100 μg subgroup and matching placebo of multiple MRI-defined structural alterations. Analyses included a delta-subregional and delta-sum approach for the whole knee and the medial and lateral tibio-femoral (MTFJ, LTFJ), and patello-femoral (PFJ) compartments, taking into account number of subregions showing no change, improvement or worsening and changes in the sum of subregional scores. Mann-Whitney - Wilcoxon tests assessed differences between groups.
resultsFifty-seven and 18 patients were included in the treatment and matched placebo subgroups. Less worsening of cartilage damage was observed from baseline to 12 months in the PFJ (0.02, 95 % confidence interval (CI) (-0.04, 0.08) vs. placebo 0.22, 95 % CI (-0.05, 0.49), p = 0.046). For bone marrow lesions (BMLs), more improvement was observed from 6 to 12 months for whole knee analyses (-0.14, 95 % CI (-0.48, 0.19) vs. placebo 0.44, 95 % CI (-0.15, 1.04), p = 0.042) although no significant effects were seen from the baseline visit, or in Hoffa-synovitis, effusion-synovitis, menisci and osteophytes.
conclusionsIn this post-hoc analysis cartilage showed less worsening from baseline to 12 months in the PFJ, and BMLs showed more improvement from 6 to 12 months for the whole knee.
trial registrationClinicalTrials.gov identifier: NCT01033994 .
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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.