- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04948281
Joint Infection Following ACL Reconstruction
8. juli 2021 opdateret af: Peking University Third Hospital
The Effects of Joint Infection Following Arthroscopic Single-bundle ACL Reconstruction With Autologous Hamstring: a Retrospective Matched Cohort Study
This study was conducted to analyze the effect of joint infection on the bone tunnel, graft and articular cartilage following arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with autologous hamstring, to summarize the features of MR findings after joint infection, and to correlate these findings with their possible factors.
Studieoversigt
Detaljeret beskrivelse
A retrospective matched cohort study was performed in 26 patients who underwent arthroscopic single-bundle ACL reconstruction with hamstring graft and developed postoperative joint infection in our institute from January 2002 to December 2017.
They were matched 1:3 to patients who did not sustain joint infection after ACL reconstruction.
MR scan was collected at the time of follow-up.
Bone tunnel enlargement at tunnel aperture, midsection and exit of tibial and femoral tunnel was carefully assessed.
Graft signal-to-noise quotient (SNQ) on MRI was calculated to evaluate graft maturity.
Cartilage morphology was graded using Whole Organ Magnetic Resonance Imaging Score.
A generalized linear mixed model was applied to analyze the effect of joint infection on the bone tunnel, graft and articular cartilage.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
104
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100191
- Peking University Third Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 50 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
The study population were from 20549 arthroscopic ACL reconstruction surgeries in our institute between January 2002 to December 2017.
Beskrivelse
Inclusion Criteria:
- Age between 16 to 50 years;
- Underwent single-bundle ACL reconstruction with autologous hamstring;
- Had valid follow-up magnetic resonance imaging (MRI) at least 1 year after surgery
Exclusion Criteria:
- Concomitant ligament injury which need surgical repair;
- Delayed onset of postoperative joint infection (>3 months after surgery).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Infection Group
A group of joint infection patients after arthroscopic ACL reconstruction surgery , diagnose was made according to American CDC criteria of joint infection
|
intet indgreb
|
|
Control Group
A group of patients which were matched to infections group retrospectively one-to-three who did not sustain any kind of infection after ACL reconstruction.
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intet indgreb
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tunnel enlargement
Tidsramme: 1 year after operation/infection
|
A 3.0T MRI unit (General Electric Healthcare) with an 8-channel coil was used for measurement.
Anteroposterior and lateromedial diameter at tunnel aperture, midsection and exit of tibial and femoral tunnel (demonstrated as TTa, TTm, TTe, FTa, FTm, FTe) was measured on T1-weighted images (in millimeters)
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1 year after operation/infection
|
|
Graft signal intensity
Tidsramme: 1 year after operation/infection
|
Proton Density weighted fat suppressed turbo-spin echo (PD-TSE-FS) sequence was taken to calculate the SNQof the graft.
Graft signal intensity was measured at proximal, middle and distal end of the graft.
|
1 year after operation/infection
|
|
Cartilage morphology
Tidsramme: 1 year after operation/infection
|
The cartilage morphology at surgery was assessed using Outerbridge classification for chondral lesion and recorded in operation note.
cartilage morphology was assessed according to the Whole-organ magnetic scoring system (WORMS) of the knee on sagittal and axial T2-weighted FSE images.
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1 year after operation/infection
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: yingfang ao, M.D., Peking University Third Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2019
Primær færdiggørelse (Faktiske)
1. januar 2019
Studieafslutning (Faktiske)
31. december 2020
Datoer for studieregistrering
Først indsendt
27. juni 2021
Først indsendt, der opfyldte QC-kriterier
27. juni 2021
Først opslået (Faktiske)
1. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2021
Sidst verificeret
1. juni 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- M2017332
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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