Shenzhen Hospital of Southern Medical University
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 300
- Locations
- 3
- Primary Endpoint
- operative time
Study Overview
Brief Summary
Objective: Clinical application of 3D printing implant in bone defect treatment.
Study design: multicenter randomized controlled study . Methods:patients randomly grouped according to register number into internal fixation and bone graft group and 3D printing group. Reconstruct 3D models ,evaluate models preoperatively , simulate surgery in computer,design 3D implant, and 3D print implants,perform surgery with 3D implants to achieve the greatest degree of physiological reconstruction.Evaluate surgical efficacy .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Open fracture with bone defect
- •Burst fracture of spine with bone defect
- •Bone tumor with bone defect
- •Bone tuberculosis with bone defect
- •Nonunion with bone defect
Exclusion Criteria
- •Patients who can not tolerate anesthesia and surgery due to severe impairment of heart and lung function
- •Systemic or local infection
Arms & Interventions
3D printing implant
3D printing implant in bone defect
Intervention: 3D printing implant (Procedure)
Autogenous bone grafting
autogenous bone grafting in bone defect
Intervention: autogenous bone grafting (Procedure)
Outcomes
Primary Outcomes
operative time
Time Frame: 3 years
Secondary Outcomes
No secondary outcomes reported
Investigators
fang guofang
Shenzhen Hospital of Southern Medical University
Shenzhen Hospital of Southern Medical University