Comparison of the Safety and Cost of a Simplified Post-Operative Radiograph (SPOR) Protocol (SPOR)
Primary Purpose
Fractures, Bone, Fracture Complications, Xray Complication
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
X-ray
No-Xray
Sponsored by
About this trial
This is an interventional treatment trial for Fractures, Bone
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Treatment Group
Arm 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.
These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04110470
First Posted
November 22, 2018
Last Updated
September 27, 2019
Sponsor
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT04110470
Brief Title
Comparison of the Safety and Cost of a Simplified Post-Operative Radiograph (SPOR) Protocol
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone, Fracture Complications, Xray Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1612 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.
Intervention Type
Diagnostic Test
Intervention Name(s)
X-ray
Intervention 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
No-Xray
Intervention Description
These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.
Primary Outcome Measure Information:
Title
Safety of a simplified post-operative radiographic protocol for fractures with stable fixation.
Description
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.
Time Frame
At six weeks.
Title
Cost-effectiveness of a simplified post-operative radiographic protocol for fractures with stable fixation.
Description
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.
Time Frame
At six weeks.
Secondary Outcome Measure Information:
Title
Patient satisfaction: with a simplified post-operative radiographic protocol.
Description
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
Time Frame
At six weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nigar Sultana
Phone
(204) 787-8691
Email
nsultana@hsc.mb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tudor V Tufescu, BSc, MD, FRCSC
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Safety and Cost of a Simplified Post-Operative Radiograph (SPOR) Protocol
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