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

U

University of Manitoba

Status and phase

Completed
Phase 3

Conditions

Simplified Postoperative Radiographs

Treatments

Other: Xray
Other: No-Xray

Study type

Interventional

Funder types

Other

Identifiers

NCT01644344
RI1211:135

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

17+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

39 participants in 2 patient groups

X-ray
Active Comparator group
Description:
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.
Treatment:
Other: Xray
No X-ray
Active Comparator group
Treatment:
Other: No-Xray

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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