Definitive Study for Non-inferiority Randomized Control Trial Comparing the Safety and Cost of a Simplified Post-Operative Radiographic (SPOR) Protocol for Selected Fractures
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Manitoba
- Enrollment
- 1,612
- Primary Endpoint
- Safety of a simplified post-operative radiographic protocol for fractures with stable fixation.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: X-ray (Diagnostic Test)
Treatment Group
These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.
Intervention: No-Xray (Diagnostic Test)
Outcomes
Primary Outcomes
Safety of a simplified post-operative radiographic protocol for fractures with stable fixation.
Time Frame: 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.
Time Frame: 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 Outcomes
- Patient satisfaction: with a simplified post-operative radiographic protocol.(At six weeks.)