Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603831
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 casesThe 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 implantsDespite 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 patients 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 surgeons 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 theres 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 its a cost-effective methodology For this reason a multi-centre randomized and prospective study is proposed to evaluate digital surgerys 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
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 surgeons 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 theres 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 its a cost-effective methodology For this reason a multi-centre randomized and prospective study is proposed to evaluate digital surgerys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None