NCT03152916

Brief Summary

This study aims to use 3D printing personalized plate to locate the position in which the K-wires would be drilled to save operation time and decrease the number of times that the K-wires are drilled.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2014

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

4.7 years

First QC Date

May 5, 2017

Last Update Submit

November 18, 2018

Conditions

Ankle Injuries

Keywords

subtalar jointarthrodesis3d printing

Outcome Measures

Primary Outcomes (1)

  • Operation time

    Operation time for internal fixation

    Intraoperative

Secondary Outcomes (2)

  • Postoperative subtalar VAS score

    Postoperative 1,6,12 months

  • Fusion rate

    Postoperative 1,6,12 months

Study Arms (1)

3D printing personalized plate

EXPERIMENTAL

3D printing personalized plate will be used to guide the Kirschner wires in the joint fusion surgery.

Device: 3d printing personalized plate

Interventions

3d printing personalized plateDEVICE

3d printing personalized plate will be used in the subtalar arthrodensis

3D printing personalized plate

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who receive subtalar arthrodesis and consider internal fixation with screws

You may not qualify if:

  • Patients who receive subtalar arthrodesis but do not consider internal fixation with screws

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Related Publications (1)

  • Zhang C, Cao J, Zhu H, Fan H, Yang L, Duan X. Endoscopic Treatment of Symptomatic Foot and Ankle Bone Cyst with 3D Printing Application. Biomed Res Int. 2020 Dec 26;2020:8323658. doi: 10.1155/2020/8323658. eCollection 2020.

    PMID: 33426066DERIVED

MeSH Terms

Conditions

Ankle InjuriesAnkylosis

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Xiaojun Duan, MD

    Southwest Hospital, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojun Duan, MD

CONTACT

86-23-68765290duanxiaojun@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of the Center for Joint Surgery

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 15, 2017

Study Start

January 1, 2014

Primary Completion

August 30, 2018

Study Completion

December 31, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)