Evidence map›Paper›PMID 34102950›Full record

ArticleActa orthopaedica2021

The STRYDE limb lengthening nail is susceptible to mechanically assisted crevice corrosion: an analysis of 23 retrieved implants.

Morten Stendahl Jellesen, Trine Nybo Lomholt, Rikke Quist Hansen, Troels Mathiesen, Carsten Gundlach, Søren Kold, Tobias Nygaard, Mindaugas Mikuzis, Ulrik Kähler Olesen, Jan Duedal Rölfing

Open access · goldAbstract read
In one paragraph

Article in Acta orthopaedica, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
4.6field-weighted citation impact, top 4% 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

14 citing papers in PubMed, 25 citations in OpenAlex.

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  12. Fitbone vs Precice: Is There a Difference in Regenerate Healing?Strategies in trauma and limb reconstruction
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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

10 authors at 5 institutions in 1 country.

Morten Stendahl JellesenDepartment of Mechanical Engineering, Technical University of Denmark, Lyngby.
Trine Nybo LomholtMaterials and Product Testing, FORCE Technology, Brøndby.
Rikke Quist HansenDepartment of Mechanical Engineering, Technical University of Denmark, Lyngby.
Troels MathiesenMaterials and Product Testing, FORCE Technology, Brøndby.
Carsten GundlachDepartment of Physics, Technical University of Denmark, Lyngby.
Søren KoldDepartment of Orthopaedics, Interdisciplinary Orthopaedics, Aalborg University Hospital, Aalborg.
Tobias NygaardDepartment of Orthopaedics, Limb Lengthening and Bone Reconstruction Unit, Rigshospitalet, Copenhagen.
Mindaugas MikuzisDepartment of Orthopaedics, Interdisciplinary Orthopaedics, Aalborg University Hospital, Aalborg.
Ulrik Kähler OlesenDepartment of Orthopaedics, Limb Lengthening and Bone Reconstruction Unit, Rigshospitalet, Copenhagen.
Jan Duedal RölfingOrthopaedic Reconstruction and Children's Orthopaedics, Aarhus University Hospital, Aarhus, Denmark.
Technical University of Denmark · DKAalborg University Hospital · DKFORCE Technology (Denmark) · DKRigshospitalet · DKAarhus University Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and purpose - We noted several adverse events in patients in whom the first version of the STRYDE limb-lengthening nail (NuVasive Specialized Orthopaedics, San Diego, CA) had been implanted. Pain, osteolysis, periosteal reactions, and cortical hypertrophy at the nail junction were noted. Here, we present the analysis of 23 retrieved STRYDE implants.Materials and methods - We undertook visual inspection of the retrieved nails and screws, mechanical evaluation of the junction, micro-CT analyses, microscopic inspection of the bushing, screws, screw holes, and separated parts of the implants. Positive material identification (PMI) and energy-dispersive X-ray spectroscopy (EDS) were used to analyze the chemical composition. The hardness of the material was also investigated.Results - 20/23 retrieved nails had visible signs of corrosion, i.e., discoloration at the telescopic junction. Micro-CT verified corrosion attacks in 12/12 scanned bushings. Corrosion, predominantly mechanically assisted crevice corrosion, was observed at the locking screws and screw holes in 20/23 nails. Biological material inside the nail was observed in addition to oozing from the junction of 2 nails during hardware removal, which was experimentally reproducible. Notably, the mechanical construction of the bushing changed from PRECICE P2 to STRYDE nails.Interpretation - STRYDE nails are not hermetically sealed, and liquid can pass the bushing. Biodur 108 itself is corrosion resistant; however, mechanically assisted crevice corrosion of the bushing, locking screws, and screw holes may be aggravated due to manufacturing aiming for increased strength and hardness of the alloy.Observing several adverse events, we recently published a nationwide cross-sectional analysis of all 30 STRYDE limb- lengthening nails (NuVasive, Specialized Orthopedics, San Diego, CA) that were implanted in Denmark (Rölfing et al. 2021a). 27/30 STRYDE nails have now been removed and we present data from metallurgical analysis of 23 of the retrieved implants.

Indexed as

AdolescentAdultAgedBone LengtheningBone NailsBone ScrewsChildCorrosionCross-Sectional StudiesDenmarkDevice RemovalFemurHumansMiddle AgedTibiaYoung Adult

Identifiers

PMID34102950
PMCPMC8519523
OpenAlexW3171350837

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.