Evidence map›Paper›PMID 32150598›Full record

Trial reportPloS one2020

Safety, prosthesis wearing time and health-related quality of life of lower extremity bone-anchored prostheses using a press-fit titanium osseointegration implant: A prospective one-year follow-up cohort study.

R Atallah, H van de Meent, L Verhamme, J P Frölke, R A Leijendekkers

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
5.1field-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

27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.

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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

5 authors at 1 institution in 1 country.

R AtallahDepartment of Orthopaedics, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-4127-6105
H van de MeentDepartment of Rehabilitation Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
L VerhammeDepartment of Oral and Maxillofacial Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
J P FrölkeDepartment of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
R A LeijendekkersDepartment of Rehabilitation Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
Radboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe described safety and functional one-year follow-up outcomes of individuals with lower limb amputation treated with bone-anchored prostheses using titanium press-fit osseointegration implants.

methodsAll consecutive individuals treated between March 2015 and June 2018 with curved osseointegration femur implant (OFI-C) indicated for a long femoral remnant, gamma osseointegration femur implant (OFI-Y) indicated for a short femoral remnant, or osseointegration tibia implant (OTI) were eligible for this study. All adverse events were evaluated, infections were graded as follows: grade 1 and 2: low- and high-grade soft tissue infection, respectively, grade 3: deep bone infection, grade 4: septic implant failure. Functional outcome measures included prosthesis wearing time (PUS), health-related quality of life (GS), and the overall situation as an amputee (GS Q3); evaluated with the Questionnaire of persons with trans-femoral amputation (Q-TFA) before surgery and at one-year follow-up.

resultsNinety of 91 individuals were included (mean age: 54±14 yrs, 26 females); treated with 53, 16 and 21 OFI-C, OFI-Y and OTI, respectively. Soft tissue infections (grade 1: 11 events, grade 2: 10 events) were treated successfully with antibiotics except in two (OFI-C and OFI-Y), who required additional surgery due to recurrent stoma irritation and peri-stoma abscess drainage. One individual with dysvascular amputation (OTI) developed septic implant loosening and occlusion of the femoral artery resulting in a transfemoral amputation. No aseptic loosening's occurred. One individual (OFI-Y) required stoma surgical refashioning due to soft tissue redundancy. At baseline mean ±SD and median (25th to 75th PCTL) Q-TFA PUS and GS were 52±39, 52(7-90) and 40±19, 42(25-50) and improved significantly to 88±18, 90 (90-100) and 71±15, 75 (67-83) at one-year follow-up. The GS Q3 improved over time.

conclusionTitanium osseointegration implants can be safely used within a one-year follow-up period. The performance improved compared to the use of a socket-suspended prosthesis.

Indexed as

Quality of LifeSafetyAdultAgedAged, 80 and overBone-Anchored ProsthesisFemaleFemurFollow-Up StudiesHumansLower ExtremityMaleMiddle AgedOsseointegrationProspective StudiesTime FactorsTitanium

Identifiers

PMID32150598
PMCPMC7062258
OpenAlexW3010605208

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.