Surgical applications of three-dimensional printing: a review of the current literature & how to get started.
Don Hoang, David Perrault, Milan Stevanovic...
https://pubmed.ncbi.nlm.nih.gov/28090512Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06603831
Randomized, Prospective and Multicenter Clinical Study for the Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology and Orthopedic Surgery
Led by Corporacion Parc Tauli · Updated on 2024-11-12
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Corporacion Parc Tauli
Lead Sponsor
H
Hospital Clinic of Barcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 3D digital surgery compared to conventional 2D surgery in traumatology and orthopedic surgery. This study aims to assess the clinical benefits and cost-effectiveness of digital surgery, which uses patient-specific instruments and personalized implants to potentially improve surgical outcomes and reduce complications. The trial focuses on three surgical procedures: distal radius osteotomy, acetabular arthroplasty, and spinal arthrodesis. Participants are randomly assigned to either the 3D digital surgery group, which involves 3D surgical planning, personalized surgical guides, and implants made through 3D printing, or the conventional surgery group, which uses 2D imaging, free-hand surgery, and generic implants. The surgery types studied are radius osteotomy, acetabular arthroplasty, and spinal arthrodesis. This is a prospective, multi-center, randomized clinical trial with double masking. Participants will undergo CT scans before surgery and 21 days after surgery to measure implant accuracy and positioning. Pain, quality of life, and functionality are assessed before surgery, 21 days after, and 12 months after surgery using specific questionnaires. Surgical time, materials used, fluoroscopy time, complications, and follow-up visits are also monitored. The study aims to provide evidence on both clinical outcomes and economic impact, with a planned end date in 2027.
CONDITIONS
Brief Title
Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients requiring one of these surgeries: radius osteotomy due to non-articular metaphyseal malunion, complex acetabular arthroplasty, or thoracic-lumbar spine arthrodesis.
- Patients able to read, understand, and sign the consent form.
You will not qualify if you...
- Patients unable to read, understand, or sign the consent form.
- Patients without support to complete the clinical trial.
- Patients with complex deformities or complications requiring mandatory personalized digital surgery treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Up to 1 day
Participants undergo one of three surgical procedures: distal radius osteotomy, acetabular arthroplasty, or spinal arthrodesis using either 3D digital surgery with personalized instruments and implants or conventional 2D planning and generic implants. Post-operative care lasts up to 1 day.
1 surgery visit and immediate post-operative care
Post-operative Follow-up
Duration - 12 months
Participants have follow-up visits to assess pain, quality of life, functionality, and monitor complications and recovery after surgery.
Visits before surgery, at 21 days after surgery, and at 12 months after surgery
Trial Site Locations
Total: 1 location
1
Hospital Parc Taulí
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
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Research Team
X
Xavier Garcia-Ruz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Zhicheng Song, Wenpei Dong, Dongchao Yang...
https://pubmed.ncbi.nlm.nih.gov/34140800Current trends in three-dimensional visualization and real-time navigation as well as robot-assisted technologies in hepatobiliary surgery.
Yun Wang, Di Cao, Si-Lin Chen...
https://pubmed.ncbi.nlm.nih.gov/346214693D Printing and Virtual Surgical Planning in Oral and Maxillofacial Surgery.
Adeeb Zoabi, Idan Redenski, Daniel Oren...
https://pubmed.ncbi.nlm.nih.gov/355665113D printing and its applications in orthopaedic trauma: A technological marvel.
Hitesh Lal, Mohit Kumar Patralekh
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Ferran Fillat-Gomà, Francesc Antoni Marcano-Fernández, Sergi Coderch-Navarro...
https://pubmed.ncbi.nlm.nih.gov/33632605Errors in Implant Positioning Due to Lack of Planning: A Clinical Case Report of New Prosthetic Materials and Solutions.
Marco Tallarico, Roberto Scrascia, Marco Annucci...
https://pubmed.ncbi.nlm.nih.gov/32316361The impact of hip implant alignment on muscle and joint loading during dynamic activities.
Casey A Myers, Peter J Laz, Kevin B Shelburne...
https://pubmed.ncbi.nlm.nih.gov/29482087The relationship between the survival of total knee arthroplasty and postoperative coronal, sagittal and rotational alignment of knee prosthesis.
Young-Hoo Kim, Jang-Won Park, Jun-Shik Kim...
https://pubmed.ncbi.nlm.nih.gov/24173677Corrective osteotomy of distal radius malunions using three-dimensional computer simulation and patient-specific guides to achieve anatomic reduction.
Maartje Michielsen, Annemieke Van Haver, Veronique Bertrand...
https://pubmed.ncbi.nlm.nih.gov/29926244