A Prospective Trial Comparing the Cost of Post Operative X-rays for Fractures Treated With Stable Internal Fixation (SPOR)
3. oktober 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
39
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
- Health Sciences Centre
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
17 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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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.
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Aktiv komparator: No X-ray
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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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
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Cost-effectiveness will be measured by calculating cost of x-ray, patient care and time spent by patient in clinic.
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post-operative day one or two in hospital, as well as in clinic at two and six weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Patient satisfaction
Tidsramme: At six weeks post-op
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Validated Patient Satisfaction Questionnaire to be used to measure patient satisfaction with a simplified post-operative radiographic protocol.
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At six weeks post-op
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. januar 2012
Primær fullføring (Faktiske)
1. august 2012
Studiet fullført (Faktiske)
1. august 2012
Datoer for studieregistrering
Først innsendt
12. juli 2012
Først innsendt som oppfylte QC-kriteriene
18. juli 2012
Først lagt ut (Anslag)
19. juli 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. oktober 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. oktober 2012
Sist bekreftet
1. mars 2012
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- RI1211:135
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