Evidence map›Paper›PMID 30537856›Full record

ArticleClinical rehabilitation2019

Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study.

Ruud A Leijendekkers, Gerben van Hinte, Jan Paul Frölke, Hendrik van de Meent, Femke Atsma, Maria Wg Nijhuis-van der Sanden, Thomas J Hoogeboom

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical rehabilitation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06636136 (Transtibial Osseointegration Surgery Study), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 15% 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.

NCT06636136 narecruitingnot on this mapstarted 2025, after this paper: background citation

Transtibial Osseointegration Surgery Study (TOSS)

TypeinterventionalSponsorWalter Reed National Military Medical CenterRan2025 to 2030Enrolled30ConditionsAmputation, Traumatic, Leg, LowerArmsOPRA
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.

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  17. The nonsalvageable tibia: amputation and prosthetics.OTA international : the open access journal of orthopaedic trauma · 2024
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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

7 authors at 1 institution in 1 country.

Ruud A Leijendekkers1 Department of Orthopaedics, Physical Therapy, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID https://orcid.org/0000-0002-6158-6901
Gerben van Hinte1 Department of Orthopaedics, Physical Therapy, Radboud University Medical Center, Nijmegen, The Netherlands.
Jan Paul Frölke2 Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.
Hendrik van de Meent3 Department of Rehabilitation, Radboud University Medical Center, Nijmegen, The Netherlands.
Femke Atsma4 Department of IQ Healthcare, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
Maria Wg Nijhuis-van der Sanden1 Department of Orthopaedics, Physical Therapy, Radboud University Medical Center, Nijmegen, The Netherlands.
Thomas J Hoogeboom4 Department of IQ Healthcare, Radboud Institute for Health Sciences, 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

objectives: (1) To compare level of function, activity, health-related quality of life (HRQoL) and satisfaction in persons with a lower extremity amputation before surgery and 6- and 12-months after implantation of an osseointegration implant and (2) to report adverse events.

design: Prospective cohort study.

setting: University medical centre. SUBJECTS:: A total of 40 consecutive persons (median age: 56 years) who received a transfemoral (31) or transtibial (9) osseointegration implant, between April 2014 and March 2016.

intervention: Osseointegration implant surgery followed by a predefined rehabilitation programme. MAIN MEASURES:: Hip abductor strength, prosthetic use, back pain frequency, postoperative pain, mobility level (Timed-Up and Go (TUG) and wheelchair-boundedness), walking ability (6 minute walking test (6MWT) and walking distance in daily life), HRQoL, satisfaction regarding the prosthesis, and adverse events.

results: Strength, prosthetic use, walking distance, HRQoL, and satisfaction level increased significantly at 6- and 12-month follow-up compared to baseline ( P ⩽ 0.002). The TUG showed no change at 6-month follow-up ( P = 0.420) but improved significantly at 12-month follow-up compared to baseline ( P = 0.005). Wheelchair-boundedness decreased from 12/40 participants at baseline to 0 at follow-ups. The 6MWT ( P ⩾ 0.038) and back pain ( P ⩾ 0.437) did not change over time. Stump pain was present in 28/39 and 22/40 of the participants at 6-and 12-month follow-up, respectively. The major adverse events were managed successfully and included three dual-cone breakages and four bone fractures. An uneventful course was completed by 19/31 transfemoral and 4/9 transtibial bone-anchored prostheses users.

conclusion: Bone-anchored prostheses lead to improved performance and appear to be safe, so they might be considered for persons with socket-related problems.

Indexed as

Artificial LimbsBone-Anchored ProsthesisPhysical Functional PerformanceAdultAmputeesCohort StudiesFemaleFollow-Up StudiesHumansMaleMiddle AgedMuscle StrengthPatient SatisfactionQuality of LifeAmputeesartificial limbsfunctional outcomesosseointegrationsafety

Identifiers

PMID30537856
PMCPMC6416705
OpenAlexW2905166413

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

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.