Fractures, Bone, Fracture Complications, Xray Complication
Conditions
Brief summary
The standard post-operative radiographic protocol for the monitoring of fractures at Health Sciences Centre 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.
Interventions
DIAGNOSTIC_TESTX-ray
Patients will receive standard radiographs post-operative day one or two in hospital, as well as radiographs in clinic at two and six weeks.
DIAGNOSTIC_TESTNo-Xray
These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least one lag screw for each fracture line * At least one compression plate across each fracture line * Locked intramedullary nail * Articular/peri-articular fracture with antiglide/under-contoured plate * Tension band technique (plate included) in simple fracture pattern * Operating surgeon is confident in fixation construct, despite non-load sharing criteria.
Exclusion criteria
* Fracture \>21 days old * Age \<18 years, or open growth plates * Articular fracture with depression * Multiple orthopaedic fractures * History or radiographic appearance of osteoporosis/osteopenia or poor operative bone quality * Likely difficulty with follow-up in first 6 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of a simplified post-operative radiographic protocol for fractures with stable fixation. | At six weeks. | Incidence of adverse events with a simplified X-ray protocol within the first six weeks of treatment compared to the standard protocol. Adverse events are defined as radiographic signs of implant related failure within the first six weeks of treatment and noted on the six week radiographs. |
| Cost-effectiveness of a simplified post-operative radiographic protocol for fractures with stable fixation. | At six weeks. | Cost of a simplified X-ray protocol compared to the standard protocol. Cost-effectiveness will be measured by calculating cost of x-ray, patient care and time spent by patients in clinic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction: with a simplified post-operative radiographic protocol. | At six weeks. | A validated 17 question survey tool is used with each question in a 10 centimeter visual analog scale format. Examples of scale ranges (0-10) are provided. The following is a list of some questions asked of participants: 1. Staff don't seem to listen to anything I tell them during my consultation. Agree Disagree 2. I feel that I'm in good hands when I come to the clinic. Agree Disagree 3. I'm always given a clear explanation of why I am having tests done. Agree Disagree 4. There are some things about my care in the clinic which could be improved. Agree Disagree 5. The person I see in clinic really |
Contacts
Primary ContactNigar Sultana
Outcome results
None listed