Clinical Trial: Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: CIDUCT: Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Surgical Planning and 3D Prototyping Techniques

Brief Summary:

Comminuted intra-articular distal tibia fractures (OTA 43-C) typically are the result of high-energy trauma such as motor vehicle collisions or fall from a height. They are complex injuries often associated with significant fragment displacement and severe soft tissue injury, a combination that has long challenged orthopedic surgeons. Traditionally, surgeons use plain film (X-ray) and CT scans (2 or 3 dimensional) to determine fracture pattern and displacement. Yet, in some cases, it is still difficult to identify the relationship among bone fragments, which often makes articular restoration challenging. As a result, patients with non-anatomic joint reconstructions have a higher rate of poor outcomes.

The primary objective of this study will be to compare patient outcomes in two groups, one group who will receive enhanced pre-operative planning (3D printed plastic prototype + standard of care [SOC] imaging with 3D CT scan + plain film radiographs) and a second group who will receive pre-operative planning using SOC imaging alone (3D CT scan + plain film radiographs only). Patient outcomes collected throughout the 12 month post-operative period will include an assessment of radiographic fracture healing (union, non-union, malunion), pain using a Numeric Pain Rating Scale, Olerud and Molander Score based on patient's self-report, and development of complications (infection, wound healing, re-operation, and re-hospitalizations). The secondary objective of this study will be to evaluate whether utilizing an enhanced pre-operative plan with a 3D printed plastic prototype altered the original pre-operative plan based on SOC imaging alone (3D CT scan + plain film radiographs only).


Detailed Summary:

  1. Recruitment Patients with a comminuted distal tibia fracture (OTA 43-C type) who present for care at Inova Fairfax Medical Campus (IFMC) or at the Inova Medical Group (IMG) Orthopaedic outpatient clinic will be eligible for consent and possible enrollment in this study. Patients will not be compensated for participating in this study. Given that this is a convenience sample of patients who present with an acute traumatic injury, there are no plans to advertise or recruit patients.

  2. Subject Randomization and Blinding Procedures Eligible patients will be randomized in equal proportions to one of two groups (enhanced pre-operative planning vs. SOC pre-operative planning) using an electronic randomization system with a simple randomization table. After consent and inclusion/exclusion criteria have been confirmed, subjects will be randomized by a research coordinator/associate. All surgeons will be temporarily blinded to the randomization assignment, in order to complete an unbiased pre-operative plan (pre-randomization survey) using the SOC imaging alone (plain film radiographs and 3D CT scan). After the pre-operative plan (pre-randomization survey) is completed by the attending surgeon (using the SOC imaging alone) and submitted to the research coordinator/ associate, the surgeon will be informed of the randomization assignment. For subjects randomized to the enhanced pre-operative planning group, the surgeon will then be provided the 3D prototype and be asked to complete a post-randomization survey capturing their pre-operative plan. The biomechanics lab with arrange with the research coordinator/associate for delivery of the 3D prototype, ensuring that the temporary blinding of treatment assignment is not broken. A post-randomization survey will not be administered to surgeons with subjects randomized to the SO
    Sponsor: Inova Health Care Services

    Current Primary Outcome:

    • Patient Reported Outcome of Pain [ Time Frame: Week 6 to week 52 ]
      Patients will self-report pain using a numeric pain rating scale (NPRS), 11-point numeric scale. 0 = No pain and 10 = Worst Possible Pain
    • Patient Reported General Health State [ Time Frame: Week 6 to week 52 ]
      General Health State will be measured using the CDC HRQOL question 1, categorized into excellent, very good, good, fair, and poor.
    • Patient Functional Health Score [ Time Frame: Week 6 to week 52 ]
      Olerud and Molander Scoring System is a 9 question self-assessment of pain, stiffness, swelling, ability to climb stairs, run, jump, squat, use of supports, and work/activities of daily life. A total score of 100 is calculated, with 100 equaling best.


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Percentage of Agreement: Pre vs. Post Randomization Pre-Operative Plan [ Time Frame: 0-1 mo ]

    Items on the pre and post randomization, pre-operative plan will be compared for agreement and presented as a descriptive statistic. The number of items in agreement will be divided by the total number of items answered, multiplied by 100%.


    Original Secondary Outcome: Same as current

    Information By: Inova Health Care Services

    Dates:
    Date Received: May 26, 2016
    Date Started: September 2016
    Date Completion: August 2021
    Last Updated: September 26, 2016
    Last Verified: September 2016