Radius; DeformityNCT06603831
Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology
A study testing patients treated using 3D technology and Patient-Specific Instrumentation and Patients treated with conventional surgery, without using 3D technology in people with Radius; Deformity and Hip Osteoarthritis, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radius; Deformity, Hip Osteoarthritis, Hip Arthritis
- What is being tested?
- patients treated using 3D technology and Patient-Specific Instrumentation and Patients treated with conventional surgery, without using 3D technology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 21 Oct 2024to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Parc Taulí
Sabadell, Barcelona, 08208
Mireia Montserrat Viñas, 610523153, mmvinas@tauli.cat
Xavier Garcia, 644685674, xgarciar@tauli.cat
About this study
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
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.
Read the 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.
- Conditions
- Radius; Deformity, Hip Osteoarthritis, Hip Arthritis, Hip Arthropathy, Spine Injury, Radius; Anomaly
- Being tested
- patients treated using 3D technology and Patient-Specific Instrumentation, Patients treated with conventional surgery, without using 3D technology
- Medical subject headings
- Congenital Abnormalities, Osteoarthritis, Hip, Spinal Injuries, Spinal Fractures, Osteoarthritis, Spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients treated using 3D technology and Patient-Specific InstrumentationProcedure or surgery
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
Patients treated with conventional surgery, without using 3D technologyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 3D digital surgery group | Experimental | Not described Receives: Procedure: patients treated using 3D technology and Patient-Specific Instrumentation |
| 2D conventional surgery group | Active comparator | Not described Receives: Procedure: Patients treated with conventional surgery, without using 3D technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (14)
Demographic
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: During surgery
surgical time. Length of time for the whole surgical intervention
Outcome associated with surgery cost
Measured: During surgery
Post-operative time. Length of time for the whole post-operative procedure.
Outcome associated with surgery cost
Measured: up to 1 day
number of surgical sets and sterilized material that has been used during surgery
Outcome associated with surgery cost
Measured: During surgery
Complications that the patient can suffer during surgery
Any incidence that can happen to the patient during the whole intervention
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Radius; DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital de Granollers, Fundació Hospital d'Olot i Comarcal de la Garrotxa, Hospital de la Santa creu i Sant Pau - Barcelona, Consorci Hospitalari de Vic, Corporació de Salut del Maresme i la Selva
- Responsible party
- Principal investigator, Ferran Fillat Gomà, Corporacion Parc Tauli
- Investigators
- Ferran Fillat-Gomà, Principal investigator, Corporacion PT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603831
- Sponsor's protocol ID
- 3DAdopt
- Status last verified
- Nov 2024
- First submitted
- 22 Jul 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 28090512Song 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.
PubMed 34140800Wang 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.
PubMed 34621469Zoabi 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.
PubMed 35566511Lal 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.
PubMed 30202159Fillat-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.
PubMed 33632605Tallarico 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.
PubMed 32316361Myers 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.
PubMed 29482087Kim YH, Park JW, Kim JS, Park SD. The relationship between the survival of total knee arthroplasty and postoperative coronal, sagittal and rotational alignment of knee prosthesis. Int Orthop. 2014 Feb;38(2):379-85. doi: 10.1007/s00264-013-2097-9. Epub 2013 Sep 10.
PubMed 24173677Michielsen M, Van Haver A, Bertrand V, Vanhees M, Verstreken F. Corrective osteotomy of distal radius malunions using three-dimensional computer simulation and patient-specific guides to achieve anatomic reduction. Eur J Orthop Surg Traumatol. 2018 Dec;28(8):1531-1535. doi: 10.1007/s00590-018-2265-0. Epub 2018 Jun 20.
PubMed 29926244Coakley M, Hurt DE. 3D Printing in the Laboratory: Maximize Time and Funds with Customized and Open-Source Labware. J Lab Autom. 2016 Aug;21(4):489-95. doi: 10.1177/2211068216649578. Epub 2016 May 19.
PubMed 27197798Ballard DH, Mills P, Duszak R Jr, Weisman JA, Rybicki FJ, Woodard PK. Medical 3D Printing Cost-Savings in Orthopedic and Maxillofacial Surgery: Cost Analysis of Operating Room Time Saved with 3D Printed Anatomic Models and Surgical Guides. Acad Radiol. 2020 Aug;27(8):1103-1113. doi: 10.1016/j.acra.2019.08.011. Epub 2019 Sep 18.
PubMed 31542197Levesque JN, Shah A, Ekhtiari S, Yan JR, Thornley P, Williams DS. Three-dimensional printing in orthopaedic surgery: a scoping review. EFORT Open Rev. 2020 Aug 1;5(7):430-441. doi: 10.1302/2058-5241.5.190024. eCollection 2020 Jul.
PubMed 32818070von Campe A, Nagy L, Arbab D, Dumont CE. Corrective osteotomies in malunions of the distal radius: do we get what we planned? Clin Orthop Relat Res. 2006 Sep;450:179-85. doi: 10.1097/01.blo.0000223994.79894.17.
PubMed 16721354Delbruck H, Weber DC, Eschweiler J, Hildebrand F. 3D accuracy and clinical outcomes of corrective osteotomies with patient-specific instruments in complex upper extremity deformities: an approach for investigation and correlation. Eur J Med Res. 2022 Oct 8;27(1):197. doi: 10.1186/s40001-022-00830-9.
PubMed 36209123