Comminuted Intra-Articular Distal Tibia Fracture Fixation Using Computer Techniques

NCT02845245 | Terminated DMC

• 1 other identifier: 16-2256
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Tibial Fractures

Keywords

Comminuted intra-articular distal tibia fractures; 3D printing; pre-operative planning

Outcome Measures

Primary Outcomes (3)

• Patient Reported Outcome of Pain

  Patients will self-report pain using a numeric pain rating scale (NPRS), 11-point numeric scale. 0 = No pain and 10 = Worst Possible Pain

  Week 6 to week 52

• Patient Reported General Health State

  General Health State will be measured using the CDC HRQOL question 1, categorized into excellent, very good, good, fair, and poor.

  Week 6 to week 52

• Patient Functional Health Score

  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.

  Week 6 to week 52

Secondary Outcomes (1)

• Percentage of Agreement: Pre vs. Post Randomization Pre-Operative Plan

  0-1 mo

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Intervention

EXPERIMENTAL

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

Interventions

3D printed plastic model prototype OTHER

Intervention

3D CT scan OTHER

Intervention; Standard of Care

Plain film radiographs OTHER

Intervention; Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Inova Health Care Services: lead
• DePuy Synthes: collaborator

Study Sites (1)

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Related Publications (11)

• Muller ME, Nazarian S, Koch P, Schatzker J. The comprehensive classification of fractures of long bones. Berlin: Springer; 1990.

  BACKGROUND

• Topliss CJ, Jackson M, Atkins RM. Anatomy of pilon fractures of the distal tibia. J Bone Joint Surg Br. 2005 May;87(5):692-7. doi: 10.1302/0301-620X.87B5.15982.

  PMID: 15855374 BACKGROUND

• Koulouvaris P, Stafylas K, Mitsionis G, Vekris M, Mavrodontidis A, Xenakis T. Long-term results of various therapy concepts in severe pilon fractures. Arch Orthop Trauma Surg. 2007 Jul;127(5):313-20. doi: 10.1007/s00402-007-0306-y. Epub 2007 Mar 13.

  PMID: 17354011 BACKGROUND

• Pollak AN, McCarthy ML, Bess RS, Agel J, Swiontkowski MF. Outcomes after treatment of high-energy tibial plafond fractures. J Bone Joint Surg Am. 2003 Oct;85(10):1893-900. doi: 10.2106/00004623-200310000-00005.

  PMID: 14563795 BACKGROUND

• Sands A, Grujic L, Byck DC, Agel J, Benirschke S, Swiontkowski MF. Clinical and functional outcomes of internal fixation of displaced pilon fractures. Clin Orthop Relat Res. 1998 Feb;(347):131-7.

  PMID: 9520883 BACKGROUND

• Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg (1978). 1984;103(3):190-4. doi: 10.1007/BF00435553.

  PMID: 6437370 BACKGROUND

• Olerud and Molander Scoring System. J Orthop Trauma. 2006; 20: S102.

  BACKGROUND

• Nilsson G, Jonsson K, Ekdahl C, Eneroth M. Outcome and quality of life after surgically treated ankle fractures in patients 65 years or older. BMC Musculoskelet Disord. 2007 Dec 20;8:127. doi: 10.1186/1471-2474-8-127.

  PMID: 18096062 BACKGROUND

• Nilsson GM, Eneroth M, Ekdahl CS. The Swedish version of OMAS is a reliable and valid outcome measure for patients with ankle fractures. BMC Musculoskelet Disord. 2013 Mar 25;14:109. doi: 10.1186/1471-2474-14-109.

  PMID: 23522388 BACKGROUND

• Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

  PMID: 3785962 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Robert A Hymes, M.D.

  Inova Fairfax Medical Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: July 27, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)