Comparison of the Safety and Cost of a Simplified Post-Operative Radiograph (SPOR) Protocol

University of Manitoba

Status: Unknown

Conditions: Fracture Complications; Fractures, Bone; Xray Complication

Treatments: Diagnostic Test: X-ray; Diagnostic Test: No-Xray

Study type: Interventional

Funder types: Other

Identifiers

NCT04110470

HS22019 (B2018:067)

Details and patient eligibility

About

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.

Enrollment: 1,612 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,612 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Patients will receive standard radiographs post-operative day one or two in hospital, as well as radiographs in clinic at two and six weeks.

Treatment:

Diagnostic Test: X-ray

Treatment Group

Experimental group

Description:

These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.

Treatment:

Diagnostic Test: No-Xray