- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of patients with excellent effects
Lasso di tempo: at postoperative 3 months
|
higher value indicates better repair effect
|
at postoperative 3 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
patients with Lauge-Hansen classification
Lasso di tempo: 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
Lasso di tempo: baseline and 3 months postoperatively
|
To evaluate the healing degree of fracture
|
baseline and 3 months postoperatively
|
|
MRI findings
Lasso di tempo: baseline and 3 months postoperatively
|
To evaluate ligament repair effects
|
baseline and 3 months postoperatively
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Guobin Liu, Master, The First Affiliated Hospital of Hebei Medical University
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FirstHebei_001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .