Evidence map›Paper›PMID 39210457›Full record

ArticleJournal of orthopaedic surgery and research2024

Advantages of customization of osseointegrated implants in transfemoral amputees: a comparative analysis of surgical planning.

Valentina Betti, Giulia Galteri, Stefano Zaffagnini, Domenico Alesi, Kavin Morellato, Marco Palanca, Emanuele Gruppioni, Luca Cristofolini

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of orthopaedic surgery and research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

8 authors.

Valentina BettiDepartment of Industrial Engineering, Alma Mater Studiorum - University of Bologna, Bologna, Italy.
Giulia GalteriDepartment of Industrial Engineering, Alma Mater Studiorum - University of Bologna, Bologna, Italy.
Stefano ZaffagniniClinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Domenico AlesiClinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Kavin MorellatoCentro Protesi INAIL, Bologna, Italy.
Marco PalancaDepartment of Industrial Engineering, Alma Mater Studiorum - University of Bologna, Bologna, Italy.
Emanuele GruppioniCentro Protesi INAIL, Bologna, Italy.
Luca CristofoliniDepartment of Industrial Engineering, Alma Mater Studiorum - University of Bologna, Bologna, Italy. luca.cristofolini@unibo.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCommercially available osseointegrated devices for transfemoral amputees are limited in size and thus fail to meet the significant anatomical variability in the femoral medullary canal. This study aimed to develop a customized osseointegrated stem to better accommodate a variety of femoral anatomies in transfemoral amputees than off-the-shelf stems. Customization is expected to enhance cortical bone preservation and increase the stem-bone contact area, which are critical for the long-term stability and success of implants.

methodsA customized stem (OsteoCustom) was designed based on the statistical shape variability of the medullary canal. The implantability of the OsteoCustom stem was tested via 70 computed tomography (CT) images of human femurs and compared to that of a commercial device (OFI-C) for two different resection levels. The evaluations included the volume of cortical bone removed and the percentage of stem-bone contact area for both resection levels. Statistical significance was analyzed using paired and unpaired t tests.

resultsThe OsteoCustom stem could be virtually implanted in all 70 femurs, while the OFI-C was unsuitable in 19 cases due to insufficient cortical thickness after implantation, further emphasizing its adaptability to varying anatomical conditions. The OsteoCustom stem preserved a greater volume of cortical bone than did the OFI-C. In fact, 42% less bone was removed at the proximal resection level (3.15 cm³ vs. 5.42 cm³, p ≤ 0.0001), and 33% less at the distal resection level (2.25 cm³ vs. 3.39 cm³, p = 0.003). The stem-bone contact area was also greater for the OsteoCustom stem, particularly at the distal resection level, showing a 20% increase in contact area (52.3% vs. 32.2%, p = 0.002) compared to that of the OFI-C.

conclusionsThe OsteoCustom stem performed better than the commercial stem by preserving more cortical bone and achieving a greater stem-bone contact area, especially at distal resection levels where the shape of the medullary canal exhibits more inter-subject variability. Optimal fit in the distal region is of paramount importance for ensuring the stability of osseointegrated implants. This study highlights the potential benefits of customized osseointegrated stems in accommodating a broader range of femoral anatomies, with enhanced fit in the medullary canal.

Indexed as

AmputeesBone-Anchored ProsthesisFemurOsseointegrationProsthesis DesignAdultAgedArtificial LimbsFemaleHumansMaleMiddle AgedProsthesis ImplantationTomography, X-Ray ComputedYoung AdultAmputationBone stockBone volume removalCustomized prosthesesFemurOsseointegrated femoral implantsPersonalizationStem–bone contact area

Identifiers

PMID39210457
PMCPMC11360735

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.