NCT03185286

Brief Summary

This study aims to use 3D-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

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

December 31, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

June 9, 2017

Last Update Submit

June 12, 2017

Conditions

Bone Diseases

Keywords

3D printing, metal implant, bone defect

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    The decrease in VAS score from baseline

    Postoperative 24 months

Secondary Outcomes (4)

  • American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale

    Postoperative 24 months

  • Lower limb alignment

    Postoperative 24 months

  • Osteotylus growth

    Postoperative 24 months

  • Implant displacement

    Postoperative 24 months

Study Arms (1)

3D-printed personalized metal implant

EXPERIMENTAL

3D-printed personalized metal implant will be used in bone defect surgeries.

Device: 3d-printed personalized metal implant

Interventions

3d-printed personalized metal implantDEVICE

3d-printed personalized metal implant will be used in subtalar arthrodesis.

3D-printed personalized metal implant

Eligibility Criteria

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

You may qualify if:

  • Receive ankle or subtalar arthrodesis;
  • Refuse to use autologous bone graft or allogeneic bone graft.

You may not qualify if:

  • The local defect area is small;
  • Refuse to use permanent metal metal implant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

MeSH Terms

Conditions

Bone Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal 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
TREATMENT
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

June 9, 2017

First Posted

June 14, 2017

Study Start

December 31, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

June 14, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)