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Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging

20. november 2016 opdateret af: Guobin Liu, The First Hospital of Hebei Medical University

Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging: a Retrospective, Self-controlled, Clinical Trial With 3-month Follow-up

To verify whether X-ray combined with MRI is able to carry out correct fracture classification and postoperative evaluation in patients with ankle fractures.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

History and current related studies Intraarticular fractures and ruptures of ligaments around the joint often occur after ankle injury. Early correct treatment can effectively help joint repair, and reduce the incidence of serious complications. Ankle fractures are one of the common orthopedic fractures. X-ray is a common method for detecting ankle injury, can determine the fracture site, type and extent. However, X-ray is difficult to display ankle fracture, bone fragments, displacement, or ligament injury, so it cannot make accurate fracture classification or formulate treatment programs.

Magnetic resonance imaging (MRI) can clearly show the ankle ligament, tendon, and cartilage injury, is advantageous in the diagnosis of ligament injury after ankle fracture, and can provide accurate imaging information. MRI can provide accurate preoperative assessment of clinical indicators for the rational formulation of treatment programs to reduce complications. The observation of ankle contusion observed by MRI is conducive to analyzing the mechanism of ankle joint injury.

Therefore, X-ray combined with MRI would perfectly verify soft tissue injury after ankle fractures so as to make effective surgical program.

Adverse events Adverse events including incision pain, incision nonunion, ankle pain, peripheral nerve injury of ankle joint, ankle joint inflammation, and soft tissue injury. Severe adverse events are events occurred during clinical trial, including requiring hospitalization, prolonged hospitalization, disability, inability to work, life-threatening, or fatalities. If severe adverse events occur, investigators would report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.

Data collection, management, analysis and open-access

  1. Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events were collected.
  2. Data were processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically. All data regarding this trial were preserved by the First Hospital, Hebei Medical University, China.
  3. The electronic database was statistically analyzed by a professional statistician who created an outcome analysis report that was submitted to the lead researchers.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

68

Fase

  • Ikke anvendelig

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Ankle fractures patients detected by X-ray
  • Highly suspected ankle ligament injury
  • History of obvious trauma
  • Complete clinical data
  • Irrespective of sex and age
  • Sign the informed consent

Exclusion Criteria:

  • Cardiopulmonary function cannot tolerate anesthesia or surgery
  • Open fractures of ankle joint
  • Old fracture of the ankle joint

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: internal fixation for ankle fractures
The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging preoperatively and 3 months postoperatively.
The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of patients with excellent effects
Tidsramme: at postoperative 3 months
higher value indicates better repair effect
at postoperative 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
patients with Lauge-Hansen classification
Tidsramme: baseline
According to the degree of bone and ligament injury, there are supination-external rotation (supination-eversion), pronation-external rotation (pronation-eversion), supination-adduction and pronation-abduction.
baseline
X-ray examination
Tidsramme: baseline and 3 months postoperatively
To evaluate the healing degree of fracture
baseline and 3 months postoperatively
MRI findings
Tidsramme: baseline and 3 months postoperatively
To evaluate ligament repair effects
baseline and 3 months postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Guobin Liu, Master, The First Affiliated Hospital of Hebei Medical University

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

1. maj 2015

Primær færdiggørelse (Faktiske)

1. januar 2016

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

16. november 2016

Først indsendt, der opfyldte QC-kriterier

20. november 2016

Først opslået (Skøn)

23. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FirstHebei_001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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