Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology

Official title

Randomized, Prospective and Multicenter Clinical Study for the Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology and Orthopedic Surgery

Overview

Digital surgery, in combination with patient specific instrumentation (PSI) is being used more and more in traumatology due to its proven benefits and applications. Nowadays, medical case planning and an optimal preparation before surgery are still a challenge for surgeons. This lack of preparation is translated into longer surgical procedures, potential complications, unnecessary sterilization of materials and a high number of fluoroscopies. 2D techniques such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and X-rays remain essential for medical planning, however, in many cases, a 3D visualization is needed to achieve better results, especially in complex cases.The use of personalized medical instruments such as surgical guides has proven to increase clinical accuracy, assuring a better correction of bone deformities, and allowing a more precise location of implants and screw positioning. Furthermore, the use of 3D-printed patient-specific prosthesis can lead to better clinical outcomes as they reduce the number of complications as well as they present a longer lifespan compared to conventional generic implants.Despite the potential of 3D technology in the medical field, there is still a lack of robust studies that compares clinical benefits between digital surgery and conventional 2D surgery, and its economic impact is still unknown. Thus, the investigators propose this randomized, prospective and multi-center clinical study to evaluate the use of 3D technology in traumatology. The aim of this project is to prove that digital surgery is a cost-effective methodology and therefore it should be adopted by the public health system as a gold standard procedure.

Detailed description

3D technology is increasingly being used, especially in orthopaedic surgery and traumatology as it allows to define specific objects and to understand structures and system dynamics. From patient TC images and using a biomedical engineering software, an exact 3D virtual model of the anatomical region can be created, enabling visualization, planning and simulation of the entire surgery. Besides, this software allows to design custom-made surgical guides (that precisely define cutting zones and screw positioning) as well as personalized implants that perfectly fit the patient's anatomy. After that, Patient-Specific Instrumentation can be manufactured using 3D printers and biocompatible materials and they can be sterilized to be used in the operating room.

While personalized surgical guides increase surgical precision and surgeon satisfaction, personalized implants have shown to generate better clinical outcomes, both short and long term. Despite of the benefits that 3D technology can generate in the medical field, most surgeons still opt for conventional 2D planning techniques, free-hand surgeries and generic implants use. This results in a non-standardized and variable procedure that heavily depends on the surgeon´s experience and in many cases, the obtained results deviate from the initial goals. Scientific evidence shows that a lack of precision is strictly related to clinical complications. Poor alignment of the implants can cause damage to internal structures, increases chances of dislocations, fractures and osteolysis as well as reduces the prosthetic component lifespan. That translates into patient suffering from chronic pain, reduced functionality and an increased number of reinterventions.

Regardless of the potential and several applications of 3D technology, there´s still a lack of clinical evidence, and the economic impact is still unknown. This methodology is increasingly being used as a routine medical process in many institutions but still raises concerns regarding costs, specially when considering its use in the public health system. Although digital surgery has a wide variety of associated expenses such as hardware and software cost, equipment maintenance and 3D-specialised engineers, the cost of 3D technology has significantly decreased in the past few years and it can potentially generate economic benefits compared to the standard methodology due to the optimization of the surgical process; shorter surgeries, reduced number of unnecessary sterilized materials, reduced number of fluoroscopies during surgery and less medical complications and revisions.

Thus, a large-scale study is still needed to demonstrate: 1) clinical benefits that 3D technology can generate compared to conventional surgery and 2) thoroughly analyse its economic impact to determine if it's a cost-effective methodology. For this reason, a multi-centre, randomized and prospective study is proposed to evaluate digital surgery's clinical results and to perform a cost-effectiveness analysis in order to obtain enough scientific evidence to be able to escalate the use of 3D technology in all public health institutions.

This clinical trial is a pragmatic study that will evaluate the efficacy and effectiveness of 3D technology in 3 different surgical procedures; distal radius osteotomy, acetabular arthroplasty and spinal arthrodesis.

Interventions

• Procedure patients treated using 3D technology and Patient-Specific Instrumentation
  3D Digital surgery includes: * 3D Surgical Planning using biomedical engineering software; 3D visualization of the patients anatomy and surgical simulation. * Use of personalized surgical guides created through additive manufacturing. * Use of personalized implants created through additive manufacturing. 3 surgical procedures are studied in this study; radius osteotomy, acetabular arthroplasty and spinal arthrodesis
• Procedure Patients treated with conventional surgery, without using 3D technology
  Conventional surgery includes: * 2D planning using TC and x-rays * Free-hand surgery * Use of generic, non-personalized implants 3 surgical procedures are studied in this study; radius osteotomy, acetabular arthroplasty and spinal arthrodesis

Primary outcome measures

• Accuracy of implants location, screw positioning and correction angles in regards the previous clinical planning and positioning reference standards. [Time frame: CT will be performed before surgery and after 21 days of surgery. From this CT, positioning and correction measurements will be obtained in the lab and accuracy will be deduced.]

Secondary outcome measures (12)

• Demographic [Time frame: During patient recruitment]
• Pain of patient that undergoes any of the surgical procedures studied in this trial before and after surgery assessed by BPI-SF [Time frame: This outcome will be measured before surgery, 21 days after surgery and 12 months after surgery]
• Quality of life of patients that undergoes any of the surgical procedures studied in this trial before and after surgery will be assessed by SF-36 questionnaire [Time frame: This outcome will be measured before surgery, 21 days after surgery and 12 months after surgery]
• Quality of life of patients that undergoes any of the surgical procedures studied in this trial before and after surgery will be assessed by EQ5D-5L questionnaire [Time frame: This outcome will be measured before surgery, 21 days after surgery and 12 months after surgery]
• Functionality and pain for patients that undergoes radial osteotomy will be assessed by the specific PROM questionnaire PRWE [Time frame: This outcome will be measured before surgery, 21 days after surgery and 12 months after surgery]
• Functionality and pain for patients that undergoes hip arthroplasty will be assessed by the specific PROM questionnaire HOOS [Time frame: This outcome will be measured before surgery, 21 days after surgery and 12 months after surgery]
• Functionality and pain for patients that undergoes spinal arthrodesis will be assessed by the specific PROM questionnaire Oswerty scale [Time frame: This outcome will be measured before surgery, 21 days after surgery and 12 months after surgery]
• Number of doctors and professionals that are present in the operating room [Time frame: During surgery]
• surgical time. Length of time for the whole surgical intervention [Time frame: During surgery]
• Post-operative time. Length of time for the whole post-operative procedure. [Time frame: up to 1 day]
• number of surgical sets and sterilized material that has been used during surgery [Time frame: During surgery]
• Complications that the patient can suffer during surgery [Time frame: During surgery]

Eligibility criteria

Inclusion criteria

\- Patients that requires one of the following surgical procedures / interventions: Radius osteotomy due to non-articular metaphyseal malunion Complex acetabular arthroplasty Thoracic-lumbar spine arthrodesis.

-Patients that can understand the clinical study and that are able to read, understand and sign the consent form

Exclusion criteria

• Patients that are not able to read, understand or sign the consent form.
• Patients that can't or have no support to complete the clinical trial.
• Patients with complex deformities or complications that would require mandatory personalized digital surgery treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Parc Taulí — Sabadell

Publications

• Hoang D, Perrault D, Stevanovic M, Ghiassi A. Surgical applications of three-dimensional printing: a review of the current literature & how to get started. Ann Transl Med. 2016 Dec;4(23):456. doi: 10.21037/atm.2016.12.18. PMID 28090512
• Song Z, Dong W, Yang D, Yang J, Wu J, Wang Y, Gu Y. Application of 3D Visualization Technology in Complex Abdominal Wall Defects. Int J Gen Med. 2021 Jun 10;14:2449-2457. doi: 10.2147/IJGM.S310170. eCollection 2021. PMID 34140800
• Wang Y, Cao D, Chen SL, Li YM, Zheng YW, Ohkohchi N. Current trends in three-dimensional visualization and real-time navigation as well as robot-assisted technologies in hepatobiliary surgery. World J Gastrointest Surg. 2021 Sep 27;13(9):904-922. doi: 10.4240/wjgs.v13.i9.904. PMID 34621469
• Zoabi A, Redenski I, Oren D, Kasem A, Zigron A, Daoud S, Moskovich L, Kablan F, Srouji S. 3D Printing and Virtual Surgical Planning in Oral and Maxillofacial Surgery. J Clin Med. 2022 Apr 24;11(9):2385. doi: 10.3390/jcm11092385. PMID 35566511
• Lal H, Patralekh MK. 3D printing and its applications in orthopaedic trauma: A technological marvel. J Clin Orthop Trauma. 2018 Jul-Sep;9(3):260-268. doi: 10.1016/j.jcot.2018.07.022. Epub 2018 Aug 3. PMID 30202159
• Fillat-Goma F, Marcano-Fernandez FA, Coderch-Navarro S, Martinez-Carreres L, Berenguer A. 3D printing innovation: New insights into upper extremity surgery planning. Injury. 2021 Jul;52 Suppl 4:S117-S124. doi: 10.1016/j.injury.2021.01.048. Epub 2021 Feb 13. PMID 33632605
• Tallarico M, Scrascia R, Annucci M, Meloni SM, Lumbau AI, Koshovari A, Xhanari E, Martinolli M. Errors in Implant Positioning Due to Lack of Planning: A Clinical Case Report of New Prosthetic Materials and Solutions. Materials (Basel). 2020 Apr 16;13(8):1883. doi: 10.3390/ma13081883. PMID 32316361
• Myers CA, Laz PJ, Shelburne KB, Judd DL, Huff DN, Winters JD, Stevens-Lapsley JE, Rullkoetter PJ. The impact of hip implant alignment on muscle and joint loading during dynamic activities. Clin Biomech (Bristol). 2018 Mar;53:93-100. doi: 10.1016/j.clinbiomech.2018.02.010. Epub 2018 Feb 14. PMID 29482087

Identifiers

NCT: NCT06603831 · 3DAdopt

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗