- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02971943
Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging
Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging: a Retrospective, Self-controlled, Clinical Trial With 3-month Follow-up
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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
- Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events were collected.
- 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.
- The electronic database was statistically analyzed by a professional statistician who created an outcome analysis report that was submitted to the lead researchers.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Guobin Liu, Master, The First Affiliated Hospital of Hebei Medical University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FirstHebei_001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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Kliniske studier på Ankelskade
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Hospital Universitari Son DuretaEspen; This research prize was funded by Nestle Nutrition Institute and...FullførtModerat til alvorlig traume, som definert av en | Injury Severity Score (ISS) > 12 poeng ble inkludert i studien.Spania