Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques (CIDUCT)
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|ClinicalTrials.gov Identifier: NCT02845245|
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : July 9, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Tibial Fractures||Other: 3D printed plastic model prototype Other: 3D CT scan Other: Plain film radiographs||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CIDUCT: Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Surgical Planning and 3D Prototyping Techniques|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2021|
Active Comparator: Standard of Care
Standard of care imaging techniques (3D CT scan and plain film radiographs) will be obtained for the surgeon to pre-operatively plan the surgery.
Other: 3D CT scan
Other: Plain film radiographs
A 3D printed plastic model prototype will be developed for the surgeon to use, in addition to the standard of care imaging techniques (3D CT scan and plain film radiographs), to pre-operatively plan the surgery.
Other: 3D printed plastic model prototype
Other: 3D CT scan
Other: Plain film radiographs
- 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.
- 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%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845245
|Contact: Jihui Li, Ph.D||703-208-6038||Orthopaedic.Research@inova.org|
|United States, Virginia|
|Inova Fairfax Medical Campus||Recruiting|
|Falls Church, Virginia, United States, 22042|
|Contact: Jihui Li, PhD 703-208-6038 Orthopaedic.Research@inova.org|
|Principal Investigator:||Robert A Hymes, M.D.||Inova Fairfax Medical Campus|