ArticleEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2022
A comparison of the inflammatory host response to particulate debris adjacent to unlocked and locked screws of a growth guidance system for early onset scoliosis.
Article in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
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Who cites it
3 citing papers in PubMed, 4 citations in OpenAlex.
- From a biomechanical perspective: pathogenesis, clinical manifestations and treatment strategies of adolescent idiopathic scoliosis.Frontiers in pediatrics · 2025Review
- Tissue response following implantation with the posterior dynamic distraction device (PDDD) in adolescent idiopathic scoliosis (AIS).European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2024Article
- A Novel growth guidance system for early onset scoliosis: a preliminary in vitro study.Journal of orthopaedic surgery and research · 2024Article
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe SHILLA™ Growth Guidance system is a stainless-steel rod and screw system used for Early Onset Scoliosis which incorporates a unique flanged set screw designed to capture the rod, while allowing it to slide as the patient grows. Concomitant with this design is the potential for generation of wear debris and for an inflammatory host response. We hypothesized that the magnitude of the host response adjacent to the unlocked screws and rods would be greater than the host response to the locked rod/screws.
methodsSeven tissue samples adjacent to locked (3) and unlocked screws (4) from three SHILLA patients (mean implantation time of 19 post-operative months) with infantile idiopathic scoliosis were obtained as part of an explant analysis protocol during a PMDA-approved clinical trial in Japan. Gross appearance, high-resolution radiographs, and histology were assessed. ISO Standard 10993 Part 6 was used to assess the host response.
resultsAll three locked screw had no metallosis. In contrast, metallosis for unlocked screw tissue samples were rated as "ubiquitous" (2/4), "focal" (1/4), or "absent" (1/4). Microscopic metallic debris was found intracellularly and within interstices of fibrous connective tissues more frequently adjacent to unlocked screws compared to locked screws. Cell type and population scoring consistently showed a modestly larger inflammatory response (macrophages) in the unlocked tissue samples.
conclusionsThe peri-prosthetic tissue response to the unlocked rods/screws had a higher reactivity grade (slight reaction, Δ = 4.0) per ISO 10993 Part 6 compared to the locked screws in three patients with the SHILLA™ Growth Guidance scoliosis system.
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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.