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

Fractures, Bone Clinical Trial

— SPOR  

Official title:

Definitive Study for Non-inferiority Randomized Control Trial Comparing the Safety and Cost of a Simplified Post-Operative Radiographic (SPOR) Protocol for Selected Fractures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04110470
• Other study ID #: HS22019 (B2018:067)
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2018
• Source: University of Manitoba
• Contact: Nigar Sultana
• Phone: (204) 787-8691
• Email: nsultana[@]hsc.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1612
• Est. completion date: May 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture Complications
• Fractures, Bone
• Xray Complication

Intervention

Diagnostic Test:
• X-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.
• No-Xray
These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of a simplified post-operative radiographic protocol for fractures with stable fixation.	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.	At six weeks.
Primary	Cost-effectiveness of a simplified post-operative radiographic protocol for fractures with stable fixation.	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.	At six weeks.
Secondary	Patient satisfaction: with a simplified post-operative radiographic protocol.	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: Staff don't seem to listen to anything I tell them during my consultation.; Agree Disagree; I feel that I'm in good hands when I come to the clinic.; Agree Disagree; I'm always given a clear explanation of why I am having tests done.; Agree Disagree; There are some things about my care in the clinic which could be improved.; Agree Disagree; The person I see in clinic really	At six weeks.