Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques

Stopped early · Not applicable

Conditions studied: Tibial Fractures

In brief

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).

Key facts

Study ID

NCT02845245

Run by

Inova Health Care Services

People needed

20

Starts

2016-09-01

Expected to finish

2020-08-01

Last updated by the study team

2020-08-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 to 75 years old.
• 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.
• Standard of care imaging available for pre-operative assessment and modeling
• English speaking.
• Available for follow-up for 12 months.
• Patient signs informed consent.

You may not qualify if…

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

Where it is running

• Inova Fairfax Medical Campus — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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