3D-printed Bone Models in Addition to CT Imaging for Intra-articular Fracture Repair

Proximal Humeral Fracture Clinical Trial

— SPRINT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748016
• Other study ID #: UW 18-480
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: The University of Hong Kong
• Contact: Christian Fang
• Phone: 22554581
• Email: cfang[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of 3D-printed bone models in addition to CT imaging versus CT imaging alone on surgical quality and operation time for patients undergoing surgical repair of intra-articular fractures.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age 18 years or older

2. with intra-articular fracture of the proximal or distal humerus, proximal ulna, proximal radius, distal femur, or proximal or distal tibia (pilon fracture)

3. requiring anticipated surgical repair of fracture

4. with pre-operative CT scan already available as part of routine assessment

Exclusion Criteria:

1. pathological fracture

2. multiple fractures requiring simultaneous or staged operations

3. fractures around the hip, pelvis and acetabulum, and any other fracture types not specified in the inclusion criteria

4. requiring surgery within 24 hours of admission

5. unable or unwilling to give consent to participate

Related Conditions & MeSH terms

• Distal Femur Fracture
• Distal Humerus Fracture
• Distal Tibia Fracture
• Femoral Fractures
• Fractures, Bone
• Humeral Fractures
• Intra-Articular Fractures
• Proximal Humeral Fracture
• Shoulder Fractures
• Tibial Fractures

Intervention

Other:
• 3D printed (3DP) bone models + CT imaging
In addition to CT-MPR and CT-3DR, 3DP models will be used for surgical planning and intraoperative visualization.
• CT imaging
CT-MPR and CT-3DR used for surgical planning and intraoperative visualization.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (18)

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. — View Citation

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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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

Peltola SM, Melchels FP, Grijpma DW, Kellomäki M. A review of rapid prototyping techniques for tissue engineering purposes. Ann Med. 2008;40(4):268-80. doi: 10.1080/07853890701881788. Review. — View Citation

Rennie D. CONSORT revised--improving the reporting of randomized trials. JAMA. 2001 Apr 18;285(15):2006-7. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of articular surface reduction grading assessed by three-point scale	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
Primary	Skin to skin duration of surgery (minutes)	The skin to skin duration of the surgery will be recorded.	Immediately post-operation
Secondary	Total fluoroscopy time (seconds)	The total intraoperative fluoroscopy time will be recorded in seconds.	Immediately post-operation
Secondary	Intraoperative blood loss (mL)	The patient's blood loss during the surgery will be recorded.	Immediately post-operation
Secondary	Total length of skin incision (mm)	The total length on the incision will be measured post operation.	Immediately post-operation
Secondary	Total tourniquet time (minutes)	Total time the tourniquet was applied will be recorded.	Immediately post-operation
Secondary	Incidence of surgical complications	Incidence of infection, neurological deficit, wound breakdown, loss of fixation, revision surgery will be recorded at follow up.	3 months post-operation
Secondary	Quality of articular surface reduction grading assessed by three-point scale	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
Secondary	Health-related quality of life measured by SF-12 Chinese (HK) version	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