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OpenTrials
Completed

NCT Number: NCT01644344

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

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.

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Key information

Conditions

Simplified Postoperative Radiographs

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No-Xray

Other

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

Other

Primary outcomes

  1. cost-effectiveness of a simplified post-operative radiographic protocol for selected fractures

    Time frame: 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 outcomes

  1. Patient satisfaction

    Time frame: At six weeks post-op

    Validated Patient Satisfaction Questionnaire to be used to measure patient satisfaction with a simplified post-operative radiographic protocol.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Health Sciences Centre Foundation, Manitoba

Registry information

Official study 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

Acronym: SPOR

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 19, 2012
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.