Repair of the Large Bone Defects Through 3D Printed Individualized Porous Implant

• Conditions: Large Bone Defects
• Interventions: Device: 3D printed individualized porous implants

• Registration Number: NCT04466397
• Lead Sponsor: Peking University Third Hospital

Brief Summary

The aim of this study was to investigate the simply use of three-dimensional (3D) printed individualized porous implants in the absence of autogenous/allogeneic bone graft or any osteoinductive agents to treat the large bone defects caused by varies of pathogenesis and systematically study its long-term therapeutic effect and osseointegration characteristics.

Detailed Description

A selection of fifty-eight patients with large bone defects caused by tumor, infection or trauma received the individualized porous implants treatment, and two typical cases were chosen for detailed study. Further, the large segmental femur defect model of sheep was utilized to study the osseointegration characteristics of the individualized porous implants in 1, 3, 6 months after implantation.

Study Timeline

• Study Start: 2018-06-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-28
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-10
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Large bone defects (>4cm) in spine, limb bone and hip joint caused by tumor, infection or other pathogenesis received the individualized porous implants treatment.

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Exclusion Criteria

• Bone defects less than 4cm long.
• Bone defects treated by other methods ,such as ilizarov technique, masquelet technique or Ti mesh.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3D printed implants reconstruction group	3D printed individualized porous implants	The patients with large bone defects who treated by 3D printed individualized porous implants

Primary Outcome Measures

Name	Time	Method
Biomechanical stability	20 months after the bone defect reconstruction.	Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.

Secondary Outcome Measures

Name	Time	Method
Osseointegration	20 months after the bone defect reconstruction.	Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China