An interventional study of patients treated using 3D technology and Patient-Specific Instrumentation and Patients treated with conventional surgery, without using 3D technology in Radius; Deformity, Hip Osteoarthritis and Hip Arthritis, sponsored by Corporacion Parc Tauli. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Treatment
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.
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.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's planned enrollment of 180 is above the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Corporacion Parc Tauli is the lead sponsor of 167 studies on the registry; 25 are open to participants now.
Compared within Osteoarthritis, Hip, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Congenital Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-Patients that can understand the clinical study and that are able to read, understand and sign the consent form
Exclusion Criteria:
Procedure: patients treated using 3D technology and Patient-Specific Instrumentation
Procedure: Patients treated with conventional surgery, without using 3D technology
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
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
Accuracy of implants location, screw positioning and correction angles in regards the previous clinical planning and positioning reference standards.
CT scan will be performed before and after surgery. Digital Planning will be performed in all cases to determine the right positioning of implants and screws (and deformity angle correction if needed) that the surgeon should achieve. Implant location and screw positioning from post-surgery CT will be measured and accuracy will be obtained by comparing the final positioning and correction with the previous planning and goals. Positioning and corrections measurements in post-surgery CT Scan will also be compared to positioning reference standards to determine the number of cases where the reference safe zone positioning and corrections have been achieved in both, digital and conventional surgery.
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.
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
Pain will be assessed by BPI-SF before and after surgery and results will be compared between digital and conventional surgery to determine if there are significant results in these clinical outcomes.
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
Quality of life will be assessed by SF-36 before and after surgery and results will be compared between digital and conventional surgery to determine if there are significant results in these clinical outcomes.
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
Quality of life will be assessed by EQ5D-5L before and after surgery and results will be compared between digital and conventional surgery to determine if there are significant results in these clinical outcomes.
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
PRWE it's a patient reported outcome measures (PROMs) designed to measure wrist pain and disability in activities of daily living used for specific wrist problems
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
HOOS it's a patient reported outcome measures (PROMs) designed to evaluate symptoms and limitations for patients with hip pain.
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
Oswerty scale it's a patient reported outcome measure (PROMs) designed to evaluate pain and disability for patients that undergo arthrodesis and it's the gold standard of low back functional outcome tools.
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
Outcome associated with surgery cost
Time frame: During surgery
surgical time. Length of time for the whole surgical intervention
Outcome associated with surgery cost
Time frame: During surgery
Post-operative time. Length of time for the whole post-operative procedure.
Outcome associated with surgery cost
Time frame: up to 1 day
number of surgical sets and sterilized material that has been used during surgery
Outcome associated with surgery cost
Time frame: During surgery
Complications that the patient can suffer during surgery
Any incidence that can happen to the patient during the whole intervention
Time frame: During surgery
Amount of fluoroscopies measured in fluoroscopy scan time that is used during surgery
measure the amount of fluoroscopies that the surgeon needed during the intervention.
Time frame: During surgery
number of medical follow-up visits or hospital resources
medical visits that the patient needs after surgery. this outcome is associated with cost.
Time frame: 1 year
Plan to share: Yes — The plan is to create a data repository with all the outcomes obtained during this study for each patient. Study results will be also published in scientific reviews.
Supporting information: Statistical analysis plan, Clinical study report
Time frame: Data will be available when the study is completed and will be shared for a minimum of 25 years
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