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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
Sponsor:
Collaborator:
DePuy Synthes
Information provided by (Responsible Party):
Robert A. Hymes, Inova Health Care Services

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).


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Experimental: Intervention
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



Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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%.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Adults 18 to 75 years old.
  2. Diagnosis of a closed or open, isolated intra-articular comminuted distal tibia fracture (OTA 43-C), with plans for delayed definitive surgery. May have concomitant fracture or injury of fibula.
  3. Standard of care imaging available for pre-operative assessment and modeling
  4. English speaking.
  5. Available for follow-up for 12 months.
  6. Patient signs informed consent.

Exclusion Criteria

  1. History of musculoskeletal disease of the foot and/or ankle (i.e. arthritis).
  2. Non-ambulatory prior to injury.
  3. Bilateral lower extremity fractures.
  4. Fracture of ipsilateral talus or calcaneus.

Information from the National Library of Medicine

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


Contacts
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Contact: Jihui Li, Ph.D 703-208-6038 Orthopaedic.Research@inova.org

Locations
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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   
Sponsors and Collaborators
Inova Health Care Services
DePuy Synthes
Investigators
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Principal Investigator: Robert A Hymes, M.D. Inova Fairfax Medical Campus

Additional Information:
Publications:
Muller ME, Nazarian S, Koch P, Schatzker J. The comprehensive classification of fractures of long bones. Berlin: Springer; 1990.
Olerud and Molander Scoring System. J Orthop Trauma. 2006; 20: S102.
Newschaffer CJ. Validation of Behavioral Risk Factor Surveillance System (BRFSS) HRQOL measures in a statewide sample. Atlanta: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, 1998.

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Responsible Party: Robert A. Hymes, Orthopaedic surgeon, Inova Health Care Services
ClinicalTrials.gov Identifier: NCT02845245     History of Changes
Other Study ID Numbers: 16-2256
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators will publish results through conferences and journals; de-identified group data results.
Keywords provided by Robert A. Hymes, Inova Health Care Services:
Comminuted intra-articular distal tibia fractures
3D printing
pre-operative planning
Additional relevant MeSH terms:
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Fractures, Bone
Tibial Fractures
Fractures, Comminuted
Wounds and Injuries
Leg Injuries