Trial reportKnee surgery, sports traumatology, arthroscopy : official journal of the ESSKA2018
A multilayer biomaterial for osteochondral regeneration shows superiority vs microfractures for the treatment of osteochondral lesions in a multicentre randomized trial at 2 years.
Trial report in Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05332288 (Triphasic Osteochondral Scaffold for the Treatment of Osteochondritis Dissecans of the Knee), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.
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.
Triphasic Osteochondral Scaffold for the Treatment of Osteochondritis Dissecans of the Knee: Observational Study
Who cites it
34 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Surgery for early structural osteoarthritis of the hip and knee: the SCORE evidence synthesis and economic evaluation.Health technology assessment (Winchester, England) · 2026Pooled it
- Pooled it
- Biophysical signal-driven scaffold design for stem cell-guided osteochondral regeneration.Bioactive materials · 2026Review
- The osteochondral regeneration paradox: why biomimetic scaffolds are biologically superior but injectable systems dominate the clinic.RSC advances · 2026Review
- Advancements in Regenerative Therapies for Orthopedics: A Comprehensive Review of Platelet-Rich Plasma, Mesenchymal Stem Cells, Peptide Therapies, and Biomimetic Applications.Journal of clinical medicine · 2025Review
- Cell-free biomimetic osteochondral scaffold for the treatment of knee articular surface lesions: Clinical outcomes differ based on patient and lesion characteristics.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2025Article
- Subchondral bone: An emerging target for the treatment of articular surface lesions of the knee.Journal of experimental orthopaedics · 2024Review
- Treatment of knee cartilage lesions in 2024: From hyaluronic acid to regenerative medicine.Journal of experimental orthopaedics · 2024Review
- Does progress in microfracture techniques necessarily translate into clinical effectiveness?World journal of orthopedics · 2024Article
- Knee Cartilage Lesion Management-Current Trends in Clinical Practice.Journal of clinical medicine · 2023Review
- Autologous and Allogeneic Cytotherapies for Large Knee (Osteo)Chondral Defects: Manufacturing Process Benchmarking and Parallel Functional Qualification.Pharmaceutics · 2023Article
- Multiphasic scaffolds for the repair of osteochondral defects: Outcomes of preclinical studies.Bioactive materials · 2023Review
- Strategy Based on Michael Addition Reaction for the Development of Bioinspired Multilayered and Multiphasic 3D Constructs.Polymers · 2023Article
- Women's contribution to stem cell research for osteoarthritis: an opinion paper.Frontiers in cell and developmental biology · 2023Review
- Osteochondral regenerative engineering: challenges, state-of-the-art and translational perspectives.Regenerative biomaterials · 2023Review
- Biomechanical Aspects of Osteochondral Regeneration: Implications and Strategies for Three-Dimensional Bioprinting.Tissue engineering. Part B, Reviews · 2022Review
- Articular cartilage and osteochondral tissue engineering techniques: Recent advances and challenges.Bioactive materials · 2021Review
- The MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) 2.0 Knee Score and Atlas.Cartilage · 2021Article
- Scaffolds for Knee Chondral and Osteochondral Defects: Indications for Different Clinical Scenarios. A Consensus Statement.Cartilage · 2021Article
- Article
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe increasing awareness on the role of subchondral bone in the etiopathology of articular surface lesions led to the development of osteochondral scaffolds. While safety and promising results have been suggested, there are no trials proving the real potential of the osteochondral regenerative approach. Aim was to assess the benefit provided by a nanostructured collagen-hydroxyapatite (coll-HA) multilayer scaffold for the treatment of chondral and osteochondral knee lesions.
methodsIn this multicentre randomized controlled clinical trial, 100 patients affected by symptomatic chondral and osteochondral lesions were treated and evaluated for up to 2 years (51 study group and 49 control group). A biomimetic coll-HA scaffold was studied, and bone marrow stimulation (BMS) was used as reference intervention. Primary efficacy measurement was IKDC subjective score at 2 years. Secondary efficacy measurements were: KOOS, IKDC Knee Examination Form, Tegner and VAS Pain scores evaluated at 6, 12 and 24 months. Tissue regeneration was evaluated with MRI MOCART scoring system at 6, 12 and 24 months. An external independent agency was involved to ensure data correctness and objectiveness.
resultsA statistically significant improvement of all clinical scores was obtained from basal evaluation to 2-year follow-up in both groups, although no overall statistically significant differences were detected between the two treatments. Conversely, the subgroup of patients affected by deep osteochondral lesions (i.e. Outerbridge grade IV and OCD) showed a statistically significant better IKDC subjective outcome (+12.4 points, p = 0.036) in the coll-HA group. Statistically significant better results were also found for another challenging group: sport active patients (+16.0, p = 0.027). Severe adverse events related to treatment were documented only in three patients in the coll-HA group and in one in the BMS group. The MOCART score showed no statistical difference between the two groups.
conclusionsThis study highlighted the safety and potential of a biomimetic implant. While no statistically significant differences were found compared to BMS for chondral lesions, this procedure can be considered a suitable option for the treatment of osteochondral lesions. LEVEL OF EVIDENCE: I.
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