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

Simplified Postoperative Radiographs Clinical Trial

— SPOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644344
• Other study ID #: RI1211:135
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2012
• Last updated: October 3, 2012
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: March 2012
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Simplified Postoperative Radiographs

Intervention

Other:
• 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.
• Xray

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Health Sciences Centre Foundation, Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Patient satisfaction	Validated Patient Satisfaction Questionnaire to be used to measure patient satisfaction with a simplified post-operative radiographic protocol.	At six weeks post-op	No