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

Phase 3

Completed

• Conditions: Simplified Postoperative Radiographs
• Interventions: Other: Xray; Other: No-Xray

• Registration Number: NCT01644344
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-03
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-19
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
X-ray	Xray	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.
No X-ray	No-Xray	-

Primary Outcome Measures

Name	Time	Method
cost-effectiveness of a simplified post-operative radiographic protocol for selected fractures	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	At six weeks post-op	Validated Patient Satisfaction Questionnaire to be used to measure patient satisfaction with a simplified post-operative radiographic protocol.

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada