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A Prospective Trial Comparing the Cost of Post Operative X-rays for Fractures Treated With Stable Internal Fixation (SPOR)

3. oktober 2012 opdateret af: University of Manitoba

Pilot Study for a Randomized Control Trial Comparing the Cost of a Simplified Post-Operative Radiographic (SPOR) Protocol for Fractures With Stable Internal Fixation Treated at Health Sciences Centre

The standard post-operative radiographic protocol for the monitoring of fractures at HSC includes post-operative in hospital radiographs as well as radiographs at the two week follow up appointment. This is in addition to good quality intra-operative radiographs. With current operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal fixation. In fact, patients are often allowed to take weight through the fractured limb immediately post-operatively. In these cases, redundant post-operative radiographs likely represent an avoidable cost to the system financially, and an avoidable cost to the patient in additional time spent in hospital and unnecessary radiation exposure.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Sciences Centre

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

17 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Femur fracture treated with intramedullary nailing
  • Tibia fracture treated with intramedullary nailing
  • Ankle fractures treated with standard compression technique
  • Humeral shaft fractures treated with standard compression technique
  • Forearm fractures treated with standard compression technique
  • One or both bones fractured
  • Simple fracture or presence of single butterfly fragment treated with lag screw
  • Clavicle fracture treated with standard compression technique
  • Olecranon fracture treated with standard compression technique

Exclusion Criteria:

  • Age < 17 years, or open growth plates
  • Multiple orthopaedic fractures
  • History of radiographic appearance of osteoporosis or osteopenia or poor operative bone quality
  • Likely difficult with follow-up in first 6 weeks
  • Same day surgery case
  • Surgeon feels patient should be excluded

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: X-ray
Control group: patients will receive standard radiographs post-operative day one or two in hospital, as well as radiographs in clinic at two and six weeks. Each time radiographs are completed, the surgeon or resident will document if a change in fixation position is noted and if a change in patient management will be entertained (addition, modification or maintenance of cast or splint use, modification of or decision not to advance activity level, need for further surgery to adjust fixation or fracture reduction). The patients' time spent in clinic will be recorded upon arrival and upon completion of the patient-physician interaction.
Andet: Xray
Aktiv komparator: No X-ray
Andet: No-Xray
Treatment group: these patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks. After examining the patient, the surgeon or resident can order radiographs if required at any time. The decision will be made based on patient complaints of increased pain, appearance of abuse of the splint or cast suggesting lack of compliance or visible clinical deformity of the limb. The reason leading to radiographs will be documented by the ordering physician. If radiographs are ordered based on a wound complication, this will be specifically documented. Radiographic findings will be documented on a form identical to that used for the control group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
cost-effectiveness of a simplified post-operative radiographic protocol for selected fractures
Tidsramme: post-operative day one or two in hospital, as well as in clinic at two and six weeks
Cost-effectiveness will be measured by calculating cost of x-ray, patient care and time spent by patient in clinic.
post-operative day one or two in hospital, as well as in clinic at two and six weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient satisfaction
Tidsramme: At six weeks post-op
Validated Patient Satisfaction Questionnaire to be used to measure patient satisfaction with a simplified post-operative radiographic protocol.
At six weeks post-op

Samarbejdspartnere og efterforskere

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

Sponsor

University of Manitoba

Samarbejdspartnere

Health Sciences Centre Foundation, Manitoba

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. januar 2012

Primær færdiggørelse (Faktiske)

1. august 2012

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

12. juli 2012

Først indsendt, der opfyldte QC-kriterier

18. juli 2012

Først opslået (Skøn)

19. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2012

Sidst verificeret

1. marts 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • RI1211:135

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 .

Kliniske forsøg med Simplified Postoperative Radiographs

Kliniske forsøg med Xray

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mexico

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner