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

NCT06603831 | Recruiting

• 1 other identifier: 3DAdopt
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Radius; Deformity; Hip Osteoarthritis; Hip Arthritis; Hip Arthropathy; Spine Injury; Radius; Anomaly; Vertebra; Degeneration; Vertebral Fracture; Hip Prosthesis Infection; Spinal Fusion; Spine Osteoarthritis; Spinal Deformity

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  This outcome will be measured before surgery, 21 days after surgery and 12 months after surgery

Study Arms (2)

3D digital surgery group

EXPERIMENTAL

Procedure: patients treated using 3D technology and Patient-Specific Instrumentation

2D conventional surgery group

ACTIVE COMPARATOR

Procedure: Patients treated with conventional surgery, without using 3D technology

Interventions

patients treated using 3D technology and Patient-Specific Instrumentation PROCEDURE

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

3D digital surgery group

Patients treated with conventional surgery, without using 3D technology PROCEDURE

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

2D conventional surgery group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Hospital Clinic of Barcelona: collaborator
• Hospital de Granollers: collaborator
• Fundació Hospital d'Olot i Comarcal de la Garrotxa: collaborator
• Hospital de la Santa creu i Sant Pau - Barcelona: collaborator
• Consorci Hospitalari de Vic: collaborator
• Corporació de Salut del Maresme i la Selva: collaborator

Study Sites (1)

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

Congenital Abnormalities; Osteoarthritis, Hip; Spinal Injuries; Spinal Fractures; Osteoarthritis, Spine

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Back Injuries; Wounds and Injuries; Fractures, Bone; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases

Study Officials

• Ferran Fillat-Gomà

  Corporacion PT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Garcia-Ruz

CONTACT

644685674; xgarcia@tauli.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: September 19, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Data will be available when the study is completed and will be shared for a minimum of 25 years

Locations

ES (1)