NCT03626935

Brief Summary

This study applies 3D-printed customized guide plate in assisting the accurate drilling of Kirschner wire in ankle arthrodesis. This technique can shorten the operation time, reduce the intra-operative radiation, and do not affect the surgical outcome.

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
4.6 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

4.8 years

First QC Date

August 8, 2018

Last Update Submit

March 20, 2019

Conditions

Ankle Injuries

Keywords

ankle jointarthrodesis3d printingcustomized guide

Outcome Measures

Primary Outcomes (1)

  • Operation time

    Operation time for internal fixation

    Intraoperative

Secondary Outcomes (2)

  • Postoperative ankle AOFAS scale

    Postoperative 1,6,12 months

  • Fusion rate

    Postoperative 1,6,12 months

Study Arms (1)

3D-printed customized guide plate

EXPERIMENTAL

3D-printed customized guide plate will be used to guide the Kirschner wires in ankle arthrodesis.

Device: 3D-printed customized guide plate

Interventions

3D-printed customized guide plateDEVICE

3D-printed customized guide plate will be used in the ankle arthrodesis to help reduce operation time and reduce intra-operative radiation.

3D-printed customized guide 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 ankle arthrodesis and consider internal fixation with screws

You may not qualify if:

  • Patients who receive ankle 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

Location

Related Publications (1)

  • Duan X, He P, Fan H, Zhang C, Wang F, Yang L. Application of 3D-Printed Personalized Guide in Arthroscopic Ankle Arthrodesis. Biomed Res Int. 2018 Sep 12;2018:3531293. doi: 10.1155/2018/3531293. eCollection 2018.

    PMID: 30276205DERIVED

MeSH Terms

Conditions

Ankle InjuriesAnkylosis

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Xiaojun Duan, M.D.

    Southwest Hospital, China

    PRINCIPAL INVESTIGATOR

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

August 8, 2018

First Posted

August 13, 2018

Study Start

January 1, 2014

Primary Completion

October 31, 2018

Study Completion

July 31, 2019

Last Updated

March 22, 2019

Record last verified: 2019-03

Locations

CN(1)