NCT03166917

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

4.1 years

First QC Date

May 24, 2017

Last Update Submit

May 24, 2017

Conditions

Defect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone Graft

Outcome Measures

Primary Outcomes (1)

  • operative time

    3 years

Study Arms (2)

3D printing implant

EXPERIMENTAL

3D printing implant in bone defect

Procedure: 3D printing implant

Autogenous bone grafting

PLACEBO COMPARATOR

autogenous bone grafting in bone defect

Procedure: autogenous bone grafting

Interventions

3D printing implantPROCEDURE

3D printing implants in bone defect

3D printing implant
autogenous bone graftingPROCEDURE

3D printing implants in bone defect

Autogenous bone grafting

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who can not tolerate anesthesia and surgery due to severe impairment of heart and lung function
  • Systemic or local infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nanfang Hospital of Southern Medical University

Guangzhou, China

RECRUITING

Zhujing hospital of southern medical university

Guanzhou, China

RECRUITING

Shenzhen Hospital of Southern Medical University

Shenzhen, China

RECRUITING

Related Publications (4)

  • Li X, Wang Y, Zhao Y, Liu J, Xiao S, Mao K. Multilevel 3D Printing Implant for Reconstructing Cervical Spine With Metastatic Papillary Thyroid Carcinoma. Spine (Phila Pa 1976). 2017 Nov 15;42(22):E1326-E1330. doi: 10.1097/BRS.0000000000002229.

    PMID: 28498291BACKGROUND

  • Yang F, Chen C, Zhou Q, Gong Y, Li R, Li C, Klampfl F, Freund S, Wu X, Sun Y, Li X, Schmidt M, Ma D, Yu Y. Laser beam melting 3D printing of Ti6Al4V based porous structured dental implants: fabrication, biocompatibility analysis and photoelastic study. Sci Rep. 2017 Mar 28;7:45360. doi: 10.1038/srep45360.

    PMID: 28350007BACKGROUND

  • Mustafa SF, Evans PL, Sugar AW, Key SJ. Streamlining the manufacture of custom titanium orbital plates with a stereolithographic three-dimensional printed model. Br J Oral Maxillofac Surg. 2017 Jun;55(5):546-547. doi: 10.1016/j.bjoms.2016.03.003. Epub 2017 Apr 6. No abstract available.

    PMID: 28392025BACKGROUND

  • Tan XP, Tan YJ, Chow CSL, Tor SB, Yeong WY. Metallic powder-bed based 3D printing of cellular scaffolds for orthopaedic implants: A state-of-the-art review on manufacturing, topological design, mechanical properties and biocompatibility. Mater Sci Eng C Mater Biol Appl. 2017 Jul 1;76:1328-1343. doi: 10.1016/j.msec.2017.02.094. Epub 2017 Feb 24.

    PMID: 28482501BACKGROUND

MeSH Terms

Interventions

Printing, Three-Dimensional

Intervention Hierarchy (Ancestors)

TechnologyTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Shenzhen Hospital of Southern Medical University

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 25, 2017

Study Start

July 1, 2017

Primary Completion

August 1, 2021

Study Completion

December 31, 2021

Last Updated

May 25, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Locations

CN(3)