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 Table of Contents  
STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 4  |  Page : 177-181

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


Department of Orthopedics Trauma, Affiliated Hospital of Qinghai University, Xining, Qinghai Province, China

Date of Web Publication30-Nov-2016

Correspondence Address:
Zi-chun Zhao
Department of Orthopedics Trauma, Affiliated Hospital of Qinghai University, Xining, Qinghai Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-4157.194811

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  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.
Methods/design: We propose to conduct a prospective, single-center, randomized, controlled, open-label, clinical trial 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.
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.
Trial registration: ClinicalTrials.gov identifier: NCT02964754.
Ethics: 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.
Informed consent: Written informed consent will be provided by participants.

Keywords: clinical trials; digital orthopedics; complex long bone fractures: digital three-dimensional imaging; CT scan; internal fixation; prospective; efficacy; Harris score; visual analogy scale; adverse reactions; randomized controlled trials


How to cite this article:
Zhao Zc, Li Zw, Tang Bm, Guo Qf. Digital three-dimensional imaging models for repair of complex long bone fractures: study protocol for a randomized controlled trial with 6-month follow-up. Clin Trials Orthop Disord 2016;1:177-81

How to cite this URL:
Zhao Zc, Li Zw, Tang Bm, Guo Qf. Digital three-dimensional imaging models for repair of complex long bone fractures: study protocol for a randomized controlled trial with 6-month follow-up. Clin Trials Orthop Disord [serial online] 2016 [cited 2019 Nov 18];1:177-81. Available from: http://www.clinicalto.com/text.asp?2016/1/4/177/194811


  Introduction Top


History and current related studies

It is difficult to fit the internal fixator smoothly on the surface of the complex long bone fracture, which, if accomplished, would reduce the firmness of the fixation. From a safety point of view, establishing a digital three-dimensional (3D) measurement model is undoubtedly a more reliable, intuitive way to accomplish a tight fit (Huang et al., 2015). Digital 3D models have been established based on CT scans that reflect the site and degree of fractures (Kumta et al., 2015; Wan et al., 2015; Bi et al., 2016; Fei et al., 2016; Lin et al., 2016). They have been used to reproduce anatomical parameters with high degrees of simulation and feasibility (Ji et al., 2015; Li et al., 2015).

Main objective

We aim to verify whether digital 3D model-assisted internal fixation can obtain better effects in the repair of complex long bone fractures than conventional internal fixation.

Distinguishing features from related studies

Most previous related studies have used conventional internal fixation to repair complex long bone fractures. Our study will establish digital 3D models based on CT-derived information to provide a feasible anatomical basis for the accurate repair of complex long bone fractures that result in firm fixation and increased short- and long-term efficacy.


  Methods/Design Top


Study design

A prospective, single-center, randomized, controlled, open-label trial.

Study setting

Department of Orthopedics Trauma, Affiliated Hospital of Qinghai University, Xining, Qinghai Province, China.

Study procedures

  • Sixty-three patients with complex long bone fractures from the Affiliated Hospital of Qinghai University will be randomized into two groups. In the observation group (n = 32), digital 3D models established according to CT scan data will be used for internal fixation. In the control group (n = 31), patients will undergo conventional internal fixation.
  • All patients will be followed up for 6 months. Total efficacy, pain relief, bone morphology observed with plain radiography, hospital stay, operation time, and the incidence of adverse reactions will be compared ([Figure 1]) to investigate the feasibility of using digital 3D model-assisted internal fixation for repairing complex long bone fractures.
Figure 1: Flow chart of trial protocol

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Inclusion criteria

Patients presenting with all of the following criteria will be considered for study inclusion.

  • Long bone fractures in one of the four limbs (e.g., middle segment of the humerus, femur, ulna, radius, tibia, fibula; fractures not related to the articular surface
  • Radiographically diagnosed complex long bone fractures
  • Admission within 6 hours after injury


Exclusion criteria

Patients with one or more of the following conditions will be excluded from this study.

  • Pathological fractures with vascular and nerve injuries
  • Split fractures of the humeral head
  • Neer IV fractures
  • Humeral head compression area > 40%
  • Glenohumeral dislocation
  • Conscious disturbance, cerebral infarction, tumor, serious medical complications (e.g., heart, lung, kidney failure; severe hypertension; diabetes; blood disease)
  • History of elbow joint dysfunction or shoulder joint disease
  • Unwilling to sign the informed consent document


Baseline evaluation

The baseline information, including demographic data and general disease history of the included patients, are shown in [Table 1].
Table 1: Baseline data of included patients

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Sample size

In accordance with our experience, we hypothesized that the total efficacy at 6 months postoperatively will be 95% in the observation group and 80% in the control group. Taking β = 0.1 and power = 90% with a significance level of α = 0.05, the final effective sample size of n = 93 per group was calculated using PASS 11.0 software (NCSS, Silver Spring, MD, USA). If we assume a patient loss rate of 20%, we will require 112 patients per group. We therefore aim to include 32 patients in the final observation group and 31 patients in the control group.

Recruitment

Inpatients of the Affiliated Hospital of Qinghai University will be recruited. Potential participants can contact the project manager via telephone. After providing informed consent, these potential participants will be screened using the inclusion and exclusion criteria.

Randomization

One day before treatment, an assessor who will not know the protocols will generate a random number table using SPSS 13.0 software (SPSS, Chicago, IL, USA). According to the patient admission order, each patient will be assigned a number. The starting point and order of sampling will be arbitrarily determined on the random number table. The number of samples will be selected from the random number table. The 65 subjects will be equally and randomly assigned to an observation group (n = 32) and a control group (n = 31).

Blinding

Patients, physicians, and assessors will not be blinded to group information or the therapeutic regimen.

Establishment of digital 3D models and internal fixation

  • Image collection: Patients in the control group will be scanned with a Toshiba Aquilion 64 CT machine. The thickness of the scan was 0.5 mm and the total scan time was approximately 10-15 seconds.
  • Establishment of 3D models: CT images of patients in the observation group will be imported into Mimics 10.01-related medical image processing software (Materialise, Leuven, Belgium) through the Digital and Information Communication in Medicine format. The digital 3D models will be established after switching thresholds ([Figure 2]).
  • Measurement of anatomical image parameters: Using Mimics 10.01 software, an osteotomy will be performed on the long bone with a cutting tool. The diameter of screw position of the 3D model and the distance between two sides of the broken ends of the fracture will be measured using digital technology. The length of the indicators will be accurate to 0.01 mm. The angle between the two ends of the fracture will be measured after the operation, with the relative angle of the indicators accurate to 0.01°.
  • Internal fixation: The same group of physicians will operate on all of the patients. Patients in the observation group will undergo digital 3D measurement. Patients in the control group will undergo conventional open reduction and internal fixation. The internal fixation materials are titanium alloy anatomical plates and screws (Dabo Medical Devices Co., Ltd., Wuhan, China).
Figure 2: Establishment of digital three-dimensional imaging of the complex long bone fracture model

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Outcome measures

Primary outcome measure


  • Total efficacy: Total efficacy will be evaluated by plain radiography at 6 months postoperatively. Evaluation criteria (Sun et al., 2012) are as follows: Deterioration: The fracture site is further deformed. The internal fixator has had no effect on fracture healing and exacerbates deformation. Ineffective: Imaging shows no significant changes compared with the last time. Effective: Fracture appearance has improved significantly compared with the last time. Significant effect: The shape of the fracture site is restored to normal or close to the normal shape of the bone. Effective rate (%) = (number of cases with significant effect + number of cases with effective effect)/total number of cases × 100%.


Secondary outcome measures

  • Recovery of hip function assessed by Harris scores preoperatively and 6 months postoperatively: Harris ratings (Zhang et al., 2012): Walking distance (scores 0-11): the longer the distance, the higher the score. Seated (0-5): from uncomfortable when sitting in any chair to without discomfort when sitting in any chair for 1 hour. Malformation (1-4): the higher the malformation degree, the lower the score. Pain (0-40): the higher the pain degree, the lower the score. Climbing stairs (0-4): from "cannot go upstairs" to "up and down the stairs at a normal pace, no handrails". Limping (0-11): from "severe limping" to "no limping".
  • Injury and healing evaluated by plain radiographic findings: Fracture healing will be observed preoperatively and 6 months postoperatively. Healing criterion refers to disappearance of the fracture line.
  • Pain relief evaluated by a visual analogue scale preoperatively and 6 months postoperatively: Scores are 0-10, with the highest score representing severe pain. Score 0 = painless; > 0 but ≤ 3 = mild pain; > 3 but ≤ 6 = moderate pain; > 6 but ≤ 10 = severe pain (Knop et al., 2001).
  • Recovery of patient's condition assessed by hospital stay at 6 months postoperatively: The longer the hospital stay, the slower the patient's recovery is.
  • Speed of operation evaluated by operation time: The shorter the operation time, the more successful is the operation.


Other outcome measure

  • Incidence of adverse reactions at postoperative 6 months: To evaluate the occurrence of complications.


The schedule of outcome measurement assessments is shown in [Table 2].
Table 2: Timing of outcome assessment

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Adverse events

  • We will record adverse events, including screw loosening and falling off, steel plate fracture and bending, joint stiffness, delayed healing or non-healing, peripheral nerve injury, and infection.
  • If severe adverse events occur, investigators will report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.


Data collection, management, analysis and open access

Data collection

Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events will be collected, processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically by data managers using a double-data entry strategy.

Data management

The electronic database will be accessible and locked only by the project manager. This arrangement will not be altered. The Affiliated Hospital of Qinghai University, China will preserve all of the data regarding this trial.

Data analysis

A professional statistician will statistically analyze the electronic database and will create an outcome analysis report that will be submitted to the lead researchers. An independent data monitoring committee will supervise and manage the trial data, ensuring a scientific and stringent trial that yields accurate and complete data.

Data open access

Anonymized trial data will be published at www.figshare.com .

Statistical analysis

Statistical analysis will be performed using SPSS 13.0 software (SPSS, Chicago, IL, USA) and will follow the intention-to-treat principle. Normally distributed measurement data will be expressed as the mean ± SD and minimums and maximums. Non-normally distributed measurement data will be expressed as the lower quartile (q1) and median and upper quartiles (q3).

Fisher's exact test will be performed for comparison of total efficacy and the incidence of adverse reactions preoperatively and 6 months postoperatively. The Mann-Whitney U-test will be used to compare the Harris score, Visual Analogue Scale, operation time, and hospital stay between the two groups. The significance level will be α = 0.05.

Auditing

Trial progression will be reported to the ethics committee of Affiliated Hospital of Qinghai University, China every 3 months, and the trial's status will be updated in the registration database.

Confidentiality

Two staff members will transcribe, date, and upload the trial outcomes to a dedicated computer. An investigator will schedule, check, and lock up the data.

The data will be password-protected and not altered for future reference. No person, other than an authorized researcher, may be in contact with it.

The Affiliated Hospital of Qinghai University, China will preserve the data regarding this trial protocol.


  Trial status Top


Data analysis at the time of submission.


  Discussion Top


Significance of this study

This study aims to investigate the feasibility of digital 3D measurement after CT scanning for repair of complex long bone fractures to provide objective data for treating complex long bone fractures.

Advantages and limitations of this study

Advantages


This is a prospective, single-center, randomized, controlled, clinical trial. Imaging analysis allows a more objective conclusion regarding the fracture repair.

Limitations

Trial outcomes are single. The small sample size and inconsistent sample size in each group will affect the accuracy of the results. Follow-up time is short. Long-term efficacy and safety need to be confirmed by future studies.

Evidence for contribution to future studies

We hope this study can confirm that the digital 3D measurement after CT scanning for repair of complex long bone fractures can obtain safer, more reliable short- and long-term results than conventional internal fixation. Moreover, 3D measurements can reduce the development of adverse reactions. [11]

 
  References Top

1.
Bi C, Ji X, Wang F, Wang D, Wang Q (2016) Digital anatomical measurements and crucial bending areas of the fixation route along the inferior border of the arcuate line for pelvic and acetabular fractures. BMC Musculoskelet Disord 17:125.   Back to cited text no. 1
    
2.
Fei Q, Zhao F, Meng H, Su N, Wang BQ, Li D, Li JJ, Yang Y (2016) Modified percutaneous vertebroplasty assisted by preoperative CT-based digital design: a new technique for osteoporotic vertebral compression fracture. Zhonghua Yi Xue Za Zhi 96:731-735.   Back to cited text no. 2
    
3.
Huang JW, Luo Y, Zhang CL (2015) Biomechanical comparison and clinical analysis of three different fixation methods for medial surface and paries posterior of tibial plateau fracture. Zhongguo Yishi Zazhi 12:297-299.  Back to cited text no. 3
    
4.
Ji X, Bi C, Wang F, Jiang Y, Wang D, Wang Q (2015) Digital anatomical measurements of safe screw placement at superior border of the arcuate line for acetabular fractures. BMC Musculoskelet Disord 16:55.   Back to cited text no. 4
    
5.
Knop C, Oeser M, Bastian L, Lange U, Zdichavsky M, Blauth M (2011) Development and validation of the Visual Analogue Scale (VAS) Spine Score. Unfallchirurg 104:488-497.  Back to cited text no. 5
    
6.
Kumta S, Kumta M, Jain L, Purohit S, Ummul R (2015) A novel 3D template for mandible and maxilla reconstruction: rapid prototyping using stereolithography. Indian J Plast Surg 48:263-273.  Back to cited text no. 6
    
7.
Li Z, Zou D, Zhang J, Shao Y, Huang P, Chen Y (2015) Use of 3D reconstruction of emergency and postoperative craniocerebral CT images to explore craniocerebral trauma mechanism. Forensic Sci Int 255:106-111.  Back to cited text no. 7
    
8.
Lin H, Huang W, Chen X, Zhang G, Yu Z, Wu X, Wu C, Chen X (2016) Digital design of internal fixation for distal femoral fractures via 3D printing and standard parts database. Zhonghua Yi Xue Za Zhi 96:344-348.   Back to cited text no. 8
    
9.
Sun JB, Liao HZ, Jiang Y, Tang ZH, Sun LY, He LS (2012) Three-dimensional finite element analysis of the fixation of posterior column fracture of tibial plateau with plates and screws. Yixue Linchuang Yanjiu 29:813-817.  Back to cited text no. 9
    
10.
Wan Y, Zhuo N, Yang Y, Ge J, Lu X (2015) Effectiveness of digital customized steel plate in treatment of complex fractures of limbs. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi 29:402-405.  Back to cited text no. 10
    
11.
Zhang KR, Yu B, Dai HF, Chen YR, Cui Z, Chen ZG, Xiong XL (2012) Finite element analysis of intertrochanteric fracture fixed with dynamic hip screw and percutaneous compression plate. Zhongguo Jiaoxing Waike Zazhi 20:537-540.  Back to cited text no. 11
    

Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) gave his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Conflicts of interest
None declared.
Author contributions
ZCZ conceived and designed the trial protocol and wrote the paper. ZWL, BMT, and QFG assisted in conducting the trial. All authors approved the final version of this paper.
Plagiarism check
This paper was screened twice using CrossCheck to verify originality before publication.
Peer review
This paper was double-blinded and stringently reviewed by international expert reviewers.


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2]



 

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