CClinicalTrials.gg
Status unknownNCT03941028Updated May 7, 2019

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

An interventional study of 3D printed titanium implant in Large Segmental Bone Defect, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-07.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2019, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Large Segmental Bone Defect
03

In context

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • malignant tumor
  • patients with bad conditions failing to tolerate surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    bone defects caused by trauma

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

    Device: 3D printed titanium implant

  • Experimental
    bone defects caused by infection

    Large bone defects caused by chronic osteomyelitis

    Device: 3D printed titanium implant

  • Experimental
    bone defects caused by tumor

    Large bone defects caused by benign tumor

    Device: 3D printed titanium implant

Interventions

  • Device3D 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.

06

What researchers measure

Primary outcomes

  1. Bone reconstruction

    X-rays and CT scans are used to evaluate the bone reconstruction

    Time frame: 1 year

Secondary outcomes

  1. Questionnaire of limb function

    Restoration of limb function.

    Time frame: 1 year

Other outcomes

  1. Questionnaire of patients' satisfaction degree

    VAS score is used to evaluate the satisfaction degree. The score ranges from 0 to 10, 0 means very dissatisfied and 10 means very satisfied.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03941028
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
May 7, 2019
Start date
Jan 12, 2019
Primary completion
Jun 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
May 7, 2019

Study contacts

Bingchuan Liu, MD
Contact
liubc@bjmu.edu.cn
+86-18310188678
Yun Tian, MD
principal investigator · Peking University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion