Evidence map›Paper›PMID 35941264›Full record

ArticleJournal of artificial organs : the official journal of the Japanese Society for Artificial Organs2023

Safety of terminally gamma-ray-sterilized screws coated with fibroblast growth factor 2-calcium phosphate composite layers in non-human primates.

Yukei Matsumoto, Hirotaka Mutsuzaki, Katsuya Nagashima, Yuki Hara, Yohei Yanagisawa, Eriko Okano, Kentaro Mataki, Tadashi Sankai, Masashi Yamazaki

Abstract read
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In one paragraph

Article in Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 46% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Yukei MatsumotoDepartment of Orthopedic Surgery, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Hirotaka MutsuzakiDepartment of Orthopaedic Surgery, Ibaraki Prefectural University of Health Sciences, Ibaraki, Japan. mutsuzaki@ipu.ac.jp.
Katsuya NagashimaDepartment of Orthopedic Surgery, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Yuki HaraDepartment of Orthopedic Surgery, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Yohei YanagisawaDepartment of Orthopedic Surgery, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Eriko OkanoDepartment of Orthopedic Surgery, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Kentaro MatakiDepartment of Orthopaedic Surgery, Tokyo Medical University Ibaraki Medical Center, Ibaraki, Japan.
Tadashi SankaiTsukuba Primate Research Center, National Institutes of Biomedical Innovation, Health and Nutrition, Tsukuba, Ibaraki, Japan.
Masashi YamazakiDepartment of Orthopedic Surgery, University of Tsukuba, Tsukuba, Ibaraki, Japan.
University of Tsukuba · JPIbaraki Prefectural University of Health Sciences · JPNational Institute of Biomedical Innovation, Health and Nutrition · JPTokyo Medical University Ibaraki Medical Center · JP

Funding

Japan Agency for Medical Research and Development JP17lm0203010
6 · The paper itself

Abstract

Screws coated with fibroblast growth factor 2 (FGF-2)-calcium phosphate (CP) composite layers exhibit enhanced soft tissue and bone formation and angiogenesis because of the biological activity of FGF-2. Furthermore, the mitogenic activity of the FGF-2 within the composite layers remains unchanged after gamma-ray sterilization, which may improve the storage stability prior to clinical use. However, the in vivo safeties of these screws as spinal implants remain unknown. Here, a randomized controlled trial, involving non-human primates, investigated the safety of using FGF-2-CP composite layer-coated screws after either gamma-ray sterilization or aseptic processing. Titanium alloy screws coated with FGF-2-CP composite layers and subjected to either gamma-ray sterilization at 25 kGy (GS group) or aseptic storage (AS group) were implanted into the vertebral bodies of two cynomolgus monkeys exceeding 12 weeks (day 99). Physiological, histological, and radiographic investigations were performed to evaluate the safeties of the screws. There were no serious adverse events, such as surgical site infection, significant loss of body weight, or abnormal blood test results. No radiolucent areas were observed around the screws from the GS or AS group throughout the study. In the intraosseous region, no significant differences were observed in bone and fibrous tissue apposition rates and rate of bone formation between the two groups (p = 0.49, 0.77, and 0.11, respectively). Neither tumor lesions nor accumulation of lymphocytes and neutrophils were observed in either group. Our data suggest that FGF-2-CP composite layer-coated screws subjected to terminal gamma-ray sterilization are as safe as those fabricated in aseptic processing.

Indexed as

Bone ScrewsFibroblast Growth Factor 2AnimalsCalcium PhosphatesCoated Materials, BiocompatiblePrimatesSterilizationTitaniumcalcium phosphateCalcium PhosphatesCoated Materials, BiocompatibleFibroblast Growth Factor 2TitaniumCalcium phosphate coatingCynomolgus monkeyFibroblast growth factor-2Gamma-ray sterilizationTitanium screw

Identifiers

PMID35941264
OpenAlexW4290723840

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.