Digital three-dimensional imaging models for repair of complex long bone fractures: study protocol for a randomized controlled trial with 6-month follow-up

doi:10.3969/j.issn.2095-4344.2016.53.013

Abstract

Abstract:

BACKGROUND: During internal fixation for complex long bone fractures, it is difficult to position the internal fixator completely to the contours of the bone surface, often resulting in unstable fixation and affecting the quality of the repair. Digital three-dimensional (3D) models were therefore established based on computed tomography (CT) scans that closely reflected the site and degree of fractures, thereby guiding precise positioning of the internal fixator. From a safety point of view, the digital 3D-derived model was created to ensure that the internal fixator could achieve better repairs of complex long bone fractures.

OBJECTIVE: To investigate the application of digital 3D models for repairing complex long bone fractures.

METHODS: We propose to conduct a prospective, single-center, randomized, controlled, open-label, clinical trial with 6-month follow-up at the Department of Orthopedics Trauma, Affiliated Hospital of Qinghai University, China. Sixty-three patients with complex long bone fractures will be randomized into two groups. In the observation group (n=32), digital 3D models based on CT images will be used to establish internal fixation. In the control group (n=31), patients will undergo conventional internal fixation. All patients will be followed up for 6 months. The primary outcome will be total efficacy at 6 months postoperatively in both groups. The secondary outcomes will be (1) hip function evaluated by Harris scores before and 6 months after surgery; (2) fracture healing observed by plain radiography before and 6 months after surgery; (3) pain relief evaluated by a visual analogue scale before and 6 months after surgery; (4) assessment during the hospital stay and 6 months after surgery to assess recovery of the patient’s condition; (5) operation time to evaluate the speed of operation. Other outcome will be the incidence of adverse reactions at 6 months postoperatively. The study protocol has been approved by the Ethics Committee of Affiliated Hospital of Qinghai University of China, approval number NQH14023. All protocols will be in accordance with Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be provided by participants. This trial has registered with ClinicalTrials.gov (identifier NCT02964754) on 12 November 2016.

DISCUSSION: This trial will analyze the feasibility of digital 3D models for repairing complex long bone fractures with the aim to provide a new method for accurate, safe, reliable preoperative planning to achieve a better repair effect.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Hip Joint, Fractures, Bone

CLC Number:

R318

Zhao Zi-chun, Li Zhao-wei, Tang Bao-ming, Guo Qi-fa. Digital three-dimensional imaging models for repair of complex long bone fractures: study protocol for a randomized controlled trial with 6-month follow-up[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(53): 7992-7997.

Figures/Tables 1

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