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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
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures, Bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    November 22, 2018
    Last Updated
    September 27, 2019
    Sponsor
    University of Manitoba
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    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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