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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Fractures, Bone; Xray Complication; Fracture Complications
• Intervention / Treatment: Diagnostic test: X-ray; Diagnostic test: No-Xray

• Study Type: Interventional
• Enrollment (Anticipated): 1612
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nigar Sultana; Phone Number: (204) 787-8691; Email: nsultana@hsc.mb.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.
EXPERIMENTAL: Treatment Group; These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.	Diagnostic test: No-Xray; These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Tudor V Tufescu, BSc, MD, FRCSC, University of Manitoba

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2020
• Primary Completion (ANTICIPATED): February 1, 2024
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: November 22, 2018
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: HS22019 (B2018:067)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No