- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04748016
3D-printed Bone Models in Addition to CT Imaging for Intra-articular Fracture Repair (SPRINT)
Sterilised 3D-PRINTed Bone Models in Addition to Conventional CT Imaging for Operative Visualisation in Complex Intra-articular Fracture Repair - A Multi-centre, Double-blind Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Surgical fixation of intra-articular fractures is a technically demanding task that poses significant challenges to orthopaedic surgeons. Articular fragments may be comminuted, depressed, or impacted, and neighbouring soft tissue is often heavily compromised. Furthermore, aggressive surgical dissection is typically necessary to achieve adequate visualisation, and anatomical reduction often devitalises bone fragments and invites deep infection. The management of intra-articular fractures requires a well-designed preoperative plan and a skilfully executed surgical tactic to guarantee the best possible outcome. Multiplanar reformation (CT-MPR) and three-dimensional reconstruction (CT-3DR) are imaging techniques that have enhanced intraoperative visualisation, however, accurate analysis of complex fractures remains challenging.
3D printing is a rapidly developing, low-cost technology that is already being applied across numerous contexts in orthopaedics and traumatology. 3D printed bone models can be produced from digitised CT data in a matter of hours, providing a dimensionally accurate representation of the patient's skeleton which approximates real-life visual and tactile experiences. When used in preoperative planning, these models have shown to improve surgeon communication and shorten surgical duration. Despite positive early results, few clinical studies have studied the effect of 3D bone model use on surgical outcome. The purpose of this randomised controlled trial is to compare the effectiveness of intraoperatively utilised 3D bone models in addition to conventional CT imaging on reduction quality and surgical duration versus CT imaging alone for patients undergoing surgical fixation of complex intraarticular fractures.
Patients providing informed consent will be screened for eligibility. All eligible patients will be randomly assigned in a double-blind manner (participant and outcome assessor) to receive surgical fracture fixation with or without the addition of sterilised 3D-printed bone models to standard CT imaging for intraoperative visualisation.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christian Fang
- Phone Number: 22554581
- Email: cfang@hku.hk
Study Locations
-
-
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Hong Kong, Hong Kong
- Recruiting
- Queen Mary Hospital, the University of Hong Kong
-
Contact:
- Christian Xinshuo Fang
- Phone Number: 22554581
-
Principal Investigator:
- Christian Xinshuo Fang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 18 years or older
- with intra-articular fracture of the proximal or distal humerus, proximal ulna, proximal radius, distal femur, or proximal or distal tibia (pilon fracture)
- requiring anticipated surgical repair of fracture
- with pre-operative CT scan already available as part of routine assessment
Exclusion Criteria:
- pathological fracture
- multiple fractures requiring simultaneous or staged operations
- fractures around the hip, pelvis and acetabulum, and any other fracture types not specified in the inclusion criteria
- requiring surgery within 24 hours of admission
- unable or unwilling to give consent to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3D-printed models plus CT imaging
Fracture repair surgery using sterilized 3DP models, CT-MPR and CT-3DR for planning and intraoperative visualization
|
In addition to CT-MPR and CT-3DR, 3DP models will be used for surgical planning and intraoperative visualization.
|
Active Comparator: CT imaging alone
Fracture repair surgery using CT-MPR and CT-3DR for planning and intraoperative visualization
|
CT-MPR and CT-3DR used for surgical planning and intraoperative visualization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of articular surface reduction grading assessed by three-point scale
Time Frame: Immediately post-operation
|
The quality of articular surface reduction will be rated by two surgeons blinded to intervention allotment assessing post-operative and intraoperative fluoroscopic images.
The Kappa value will be recorded for inter-observer agreement between two observers (1.
Perfect reduction, 2. Observable imperfections 1-2mm, 3. Significant imperfections >2mm)
|
Immediately post-operation
|
Skin to skin duration of surgery (minutes)
Time Frame: Immediately post-operation
|
The skin to skin duration of the surgery will be recorded.
|
Immediately post-operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total fluoroscopy time (seconds)
Time Frame: Immediately post-operation
|
The total intraoperative fluoroscopy time will be recorded in seconds.
|
Immediately post-operation
|
Intraoperative blood loss (mL)
Time Frame: Immediately post-operation
|
The patient's blood loss during the surgery will be recorded.
|
Immediately post-operation
|
Total length of skin incision (mm)
Time Frame: Immediately post-operation
|
The total length on the incision will be measured post operation.
|
Immediately post-operation
|
Total tourniquet time (minutes)
Time Frame: Immediately post-operation
|
Total time the tourniquet was applied will be recorded.
|
Immediately post-operation
|
Incidence of surgical complications
Time Frame: 3 months post-operation
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Incidence of infection, neurological deficit, wound breakdown, loss of fixation, revision surgery will be recorded at follow up.
|
3 months post-operation
|
Quality of articular surface reduction grading assessed by three-point scale
Time Frame: 3 months post operation
|
The quality of articular surface reduction will be rated by two surgeons blinded to intervention allotment assessing post-operative and intraoperative fluoroscopic images.
The Kappa value will be recorded for inter-observer agreement between two observers (1.
Perfect reduction, 2. Observable imperfections 1-2mm, 3. Significant imperfections >2mm)
|
3 months post operation
|
Health-related quality of life measured by SF-12 Chinese (HK) version
Time Frame: 3 months post-operation
|
12-item Short Form Health Survey (SF-12), a patient-reported outcome measure of HRQOL comprised of a mental component (MCS) and physical component (PCS), each with a final score ranging from 0 (worst outcome) to 100 (best outcome).
|
3 months post-operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian Fang, Dept of Orthopaedics and Traumatology, Queen Mary Hospital
Publications and helpful links
General Publications
- Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.
- Jupiter JB, Fernandez DL, Toh CL, Fellman T, Ring D. Operative treatment of volar intra-articular fractures of the distal end of the radius. J Bone Joint Surg Am. 1996 Dec;78(12):1817-28. doi: 10.2106/00004623-199612000-00004.
- Kang HW, Lee SJ, Ko IK, Kengla C, Yoo JJ, Atala A. A 3D bioprinting system to produce human-scale tissue constructs with structural integrity. Nat Biotechnol. 2016 Mar;34(3):312-9. doi: 10.1038/nbt.3413. Epub 2016 Feb 15.
- You W, Liu LJ, Chen HX, Xiong JY, Wang DM, Huang JH, Ding JL, Wang DP. Application of 3D printing technology on the treatment of complex proximal humeral fractures (Neer3-part and 4-part) in old people. Orthop Traumatol Surg Res. 2016 Nov;102(7):897-903. doi: 10.1016/j.otsr.2016.06.009. Epub 2016 Aug 9.
- Yang L, Shang XW, Fan JN, He ZX, Wang JJ, Liu M, Zhuang Y, Ye C. Application of 3D Printing in the Surgical Planning of Trimalleolar Fracture and Doctor-Patient Communication. Biomed Res Int. 2016;2016:2482086. doi: 10.1155/2016/2482086. Epub 2016 Jul 3.
- Kacl GM, Zanetti M, Amgwerd M, Trentz O, Seifert B, Stucki H, Hodler J. Rapid prototyping (stereolithography) in the management of intra-articular calcaneal fractures. Eur Radiol. 1997;7(2):187-91. doi: 10.1007/s003300050132.
- Yan CH, Chiu KY, Ng FY, Chan PK, Fang CX. Comparison between patient-specific instruments and conventional instruments and computer navigation in total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2015 Dec;23(12):3637-45. doi: 10.1007/s00167-014-3264-2. Epub 2014 Sep 13.
- Yang J, Cai H, Lv J, Zhang K, Leng H, Sun C, Wang Z, Liu Z. In vivo study of a self-stabilizing artificial vertebral body fabricated by electron beam melting. Spine (Phila Pa 1976). 2014 Apr 15;39(8):E486-92. doi: 10.1097/BRS.0000000000000211.
- Peltola SM, Melchels FP, Grijpma DW, Kellomaki M. A review of rapid prototyping techniques for tissue engineering purposes. Ann Med. 2008;40(4):268-80. doi: 10.1080/07853890701881788.
- Brown GA, Firoozbakhsh K, DeCoster TA, Reyna JR Jr, Moneim M. Rapid prototyping: the future of trauma surgery? J Bone Joint Surg Am. 2003;85-A Suppl 4:49-55. No abstract available.
- Hurson C, Tansey A, O'Donnchadha B, Nicholson P, Rice J, McElwain J. Rapid prototyping in the assessment, classification and preoperative planning of acetabular fractures. Injury. 2007 Oct;38(10):1158-62. doi: 10.1016/j.injury.2007.05.020. Epub 2007 Sep 19.
- Bizzotto N, Tami I, Tami A, Spiegel A, Romani D, Corain M, Adani R, Magnan B. 3D Printed models of distal radius fractures. Injury. 2016 Apr;47(4):976-8. doi: 10.1016/j.injury.2016.01.013. Epub 2016 Feb 6. No abstract available.
- Li Z, Li Z, Xu R, Li M, Li J, Liu Y, Sui D, Zhang W, Chen Z. Three-dimensional printing models improve understanding of spinal fracture--A randomized controlled study in China. Sci Rep. 2015 Jun 23;5:11570. doi: 10.1038/srep11570.
- Fang C, Fang B, Wong TM, Lau TW, Pun T, Leung F. Fixing a fractured arthrodesed hip with rapid prototype templating and minimal invasive plate osteosynthesis. Trauma Case Rep. 2015 Nov 14;1(9-12):79-83. doi: 10.1016/j.tcr.2015.10.005. eCollection 2015 Dec.
- Wong TM, Jin J, Lau TW, Fang C, Yan CH, Yeung K, To M, Leung F. The use of three-dimensional printing technology in orthopaedic surgery. J Orthop Surg (Hong Kong). 2017 Jan;25(1):2309499016684077. doi: 10.1177/2309499016684077.
- Fedorov A, Beichel R, Kalpathy-Cramer J, Finet J, Fillion-Robin JC, Pujol S, Bauer C, Jennings D, Fennessy F, Sonka M, Buatti J, Aylward S, Miller JV, Pieper S, Kikinis R. 3D Slicer as an image computing platform for the Quantitative Imaging Network. Magn Reson Imaging. 2012 Nov;30(9):1323-41. doi: 10.1016/j.mri.2012.05.001. Epub 2012 Jul 6.
- Rennie D. CONSORT revised--improving the reporting of randomized trials. JAMA. 2001 Apr 18;285(15):2006-7. doi: 10.1001/jama.285.15.2006. No abstract available.
- Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database--update and key issues. N Engl J Med. 2011 Mar 3;364(9):852-60. doi: 10.1056/NEJMsa1012065.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 18-480
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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