A Prospective Trial Comparing the Cost of Post Operative X-rays for Fractures Treated With Stable Internal Fixation
SPOR
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
1 other identifier
interventional
39
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
July 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedOctober 4, 2012
March 1, 2012
7 months
July 12, 2012
October 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
cost-effectiveness of a simplified post-operative radiographic protocol for selected fractures
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
Secondary Outcomes (1)
Patient satisfaction
At six weeks post-op
Study Arms (2)
X-ray
ACTIVE COMPARATORControl 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.
No X-ray
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2012
First Posted
July 19, 2012
Study Start
January 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
October 4, 2012
Record last verified: 2012-03