Evidence map›Paper›PMID 37400903›Full record

Trial reportEuropean journal of medical research2023

TiNbSn stems with gradient changes of Young's modulus and stiffness reduce stress shielding compared to the standard fit-and-fill stems.

Kazuyoshi Baba, Yu Mori, Daisuke Chiba, Yoshiyuki Kuwahara, Hiroaki Kurishima, Hidetatsu Tanaka, Atsushi Kogure, Masayuki Kamimura, Norikazu Yamada, Susumu Ohtsu and 5 more

Abstract readClinical Trial
In one paragraph

Trial report in European journal of medical research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. 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

15 authors.

Kazuyoshi BabaDepartment of Orthopaedic Surgery, Tohoku University School of Medicine, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Yu MoriDepartment of Orthopaedic Surgery, Tohoku University School of Medicine, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan. yu-mori@med.tohoku.ac.jp.
Daisuke ChibaDepartment of Orthopaedic Surgery, Tohoku University School of Medicine, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Yoshiyuki KuwaharaDepartment of Orthopaedic Surgery, Tohoku University School of Medicine, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Hiroaki KurishimaDepartment of Orthopaedic Surgery, Tohoku University School of Medicine, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Hidetatsu TanakaDepartment of Orthopaedic Surgery, Tohoku University School of Medicine, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Atsushi KogureDepartment of Orthopaedic Surgery, Tohoku University School of Medicine, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Masayuki KamimuraDepartment of Orthopaedic Surgery, Tohoku University School of Medicine, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.
Norikazu YamadaDepartment of Orthopaedic Surgery, Sendai Red Cross Hospital, 2‑43‑3 Yagiyamahoncho, Taihaku‑ku, Sendai, Miyagi, 982-8501, Japan.
Susumu OhtsuDepartment of Orthopaedic Surgery, Osaki Citizen Hospital, 3-8-1 Furukawahonami, Osaki, Miyagi, 989-6183, Japan.
Masamizu OyamaDepartment of Orthopaedic Surgery, Sendai Red Cross Hospital, 2‑43‑3 Yagiyamahoncho, Taihaku‑ku, Sendai, Miyagi, 982-8501, Japan.
Naoya MasahashiInstitute for Materials Research, Tohoku University, 2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577, Japan.
Shuji HanadaInstitute for Materials Research, Tohoku University, 2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577, Japan.
Eiji ItoiDepartment of Orthopaedic Surgery, Tohoku Rosai Hospital, 4-3-21 Dainohara, Aoba-ku, Sendai, Miyagi, 981-0911, Japan.
Toshimi AizawaDepartment of Orthopaedic Surgery, Tohoku University School of Medicine, 1-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan.

Funding

Japan Society for the Promotion of Science 20K09404
6 · The paper itself

Abstract

backgroundThe difference between Young's moduli of the femur and the stem causes stress shielding (SS). TiNbSn (TNS) stem has a low Young's modulus and strength with gradient functional properties during the change in elastic modulus with heat treatment. The aim of this study was to investigate the inhibitory effect of TNS stems on SS and their clinical outcomes compared to conventional stems.

methodsThis study was a clinical trial. Primary THA was performed using a TNS stem from April 2016 to September 2017 for patients in the TNS group. Unilateral THA was performed using a Ti6Al4V alloy stem from January 2007 to February 2011 for patients in the control group. The TNS and Ti6Al4V stems were matched in shape. Radiographs were obtained at the 1- and 3-year follow-ups. Two surgeons independently checked the SS grade and appearance of cortical hypertrophy (CH). The Japanese Orthopaedic Association (JOA) scores before and 1 year after surgery were assessed as clinical scores.

resultsNone of the patients in the TNS group had grade 3 or 4 SS. In contrast, in the control group, 24% and 40% of patients had grade 3 and 4 SS at the 1- and 3-year follow-ups, respectively. The SS grade was lower in the TNS group than in the control group at the 1- and 3-year follow-ups (p < 0.001). The frequencies of CH in both groups were no significant difference at the 1- and 3-year follow-ups. The JOA scores of the TNS group significantly improved at 1 year after surgery and were comparable to control group.

conclusionThe TNS stem reduced SS at 1 and 3 years after THA compared to the proximal-engaging cementless stem, although the shapes of the stems matched. The TNS stem could reduce SS, stem loosening, and periprosthetic fractures.

trial registrationCurrent Controlled Trials. ISRCTN21241251. https://www.isrctn.com/search?q=21241251 . The date of registration was October 26, 2021. Retrospectively registered.

Indexed as

Arthroplasty, Replacement, HipHip ProsthesisAlloysElastic ModulusFemurHumansTitaniumAlloysTitaniumtitanium alloy (TiAl6V4)Functionally graded characteristicsLow Young’s modulusStress shieldingTiNbSn alloyTotal hip arthroplasty

Identifiers

PMID37400903
PMCPMC10316607

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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.