Clinical Effects of Large Segmental Bone Defects With 3D Printed Titanium Implant

NCT ID: NCT03941028

Last Updated: 2019-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-12

Study Completion Date

2021-12-30

Brief Summary

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The investigators apply 3D printed titanium implant to treat bone defects. Without using bone grafts and growth factors, the investigators anticipate the titanium implant alone can help bone reconstruction.

Detailed Description

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The investigators treat large segmental bone defects caused by three reasons, including trauma, infection and tumor. In this study, polyporous 3D printed titanium implant is applied to reconstruct the bone defects and the investigators will follow up patients' function and bone regeneration.

Conditions

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Large Segmental Bone Defect

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bone defects caused by trauma

Large bone defects (\>6cm) caused by trauma

Group Type EXPERIMENTAL

3D printed titanium implant

Intervention Type DEVICE

The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.

bone defects caused by infection

Large bone defects caused by chronic osteomyelitis

Group Type EXPERIMENTAL

3D printed titanium implant

Intervention Type DEVICE

The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.

bone defects caused by tumor

Large bone defects caused by benign tumor

Group Type EXPERIMENTAL

3D printed titanium implant

Intervention Type DEVICE

The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.

Interventions

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3D printed titanium implant

The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* bone defects caused by trauma or infection or tumor
* the length of bone defect is more than 6cm
* more than 18 years old

Exclusion Criteria

* malignant tumor
* patients with bad conditions failing to tolerate surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yun Tian, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bingchuan Liu, MD

Role: CONTACT

+86-18310188678

Facility Contacts

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Yun Tian, MD

Role: primary

+8610-82267010

Other Identifiers

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Z181100001718195

Identifier Type: -

Identifier Source: org_study_id

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