Ankle InjuriesNCT03152916
Application of 3D Printing Technology in Subtalar Arthrodesis
A study testing 3d printing personalized plate in people with Ankle Injuries, run by Southwest Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- 3d printing personalized plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who receive subtalar arthrodesis and consider internal fixation with screws
Who cannot join
- Patients who receive subtalar arthrodesis but do not consider internal fixation with screws
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400030
Xiaojun Duan, MD, 86-23-68765290, duanxiaojun@hotmail.com
About this study
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.
Read the detailed description
Subtalar arthrodesis is a standard procedure for treating joint injuries in terminal stage. In this study, in order to improve efficacy and shorten the operation time, personalized plate is prepared before surgery. During the surgery, the articular cartilage is scraped, then the fusion joint is reset to the functional position; the 2-2mm Kirschner wires are drilled with the assistance of the personalized plate,then the position of the fusion joint as well as the Kirschner wires are confirmed under the C-arm; lastly, cannulated screws are screwed in along the Kirschner wires for effective fixation.
In the past surgeries without personalized plate, surgeons could only rely on their experience to locate the position for drilling and then confirm under the C-arm. This would prolong the operation time and be more traumatic to the patients. Using 3D printing personalized plate can solve this problem.
The preparation procedure for the personalized plate: firstly, ankle model are established according to the patient's CT scan data, then select modular pieces to prepare the personalized plate, sterilize it for future use. Apply conventional surgical treatment to the subtalar surface, reset the fusion joint to the functional position, and drill 2-2mm Kirschner wires with the guidance of the plate. If the locations of the fusion joint and the Kirschner wires are satisfying under the C-arm inspection, drill the hollow screw for final fixation.
- Conditions
- Ankle Injuries
- Being tested
- 3d printing personalized plate
- Keywords
- subtalar joint, arthrodesis, 3d printing
- Medical subject headings
- Ankle Injuries, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d printing personalized plateDevice
3d printing personalized plate will be used in the subtalar arthrodensis
| Study group | Role | What they receive |
|---|---|---|
| 3D printing personalized plate | Experimental | 3D printing personalized plate will be used to guide the Kirschner wires in the joint fusion surgery. Receives: Device: 3d printing personalized plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
Operation time for internal fixation
Measured: Intraoperative
Secondary outcomes (2)
Postoperative subtalar VAS score
Postoperative subtalar VAS score of the patients
Measured: Postoperative 1,6,12 months
Fusion rate
Fusion rate of the subtalar joint
Measured: Postoperative 1,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Jan 2014
- Primary completion30 Aug 2018
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Duan, Southwest Hospital, China
- Investigators
- Xiaojun Duan, MD, Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152916
- Sponsor's protocol ID
- CfJSSouthwestH
- Status last verified
- Nov 2018
- First submitted
- 5 May 2017
- Last updated
- 20 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33426066
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 3D Printing Technology in Subtalar Arthrodesis
- ClinicalTrials.gov ID
- NCT03152916
- Acronym / sponsor ID
- CfJSSouthwestH
- Conditions
- Ankle Injuries
- Keywords
- subtalar joint, arthrodesis, 3d printing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subtalar arthrodesis is a standard procedure for treating joint injuries in terminal stage. In this study, in order to improve efficacy and shorten the operation time, personalized plate is prepared before surgery. During the surgery, the articular cartilage is scraped, then the fusion joint is reset to the functional position; the 2-2mm Kirschner wires are drilled with the assistance of the personalized plate,then the position of the fusion joint as well as the Kirschner wires are confirmed under the C-arm; lastly, cannulated screws are screwed in along the Kirschner wires for effective fixation.
In the past surgeries without personalized plate, surgeons could only rely on their experience to locate the position for drilling and then confirm under the C-arm. This would prolong the operation time and be more traumatic to the patients. Using 3D printing personalized plate can solve this problem.
The preparation procedure for the personalized plate: firstly, ankle model are established according to the patient's CT scan data, then select modular pieces to prepare the personalized plate, sterilize it for future use. Apply conventional surgical treatment to the subtalar surface, reset the fusion joint to the functional position, and drill 2-2mm Kirschner wires with the guidance of the plate. If the locations of the fusion joint and the Kirschner wires are satisfying under the C-arm inspection, drill the hollow screw for final fixation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D printing personalized plate | Experimental | Device: 3d printing personalized plate3D printing personalized plate will be used to guide the Kirschner wires in the joint fusion surgery. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who receive subtalar arthrodesis and consider internal fixation with screws
Key exclusion criteria (1 listed)
- Patients who receive subtalar arthrodesis but do not consider internal fixation with screws
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3d printing personalized plate3d printing personalized plate will be used in the subtalar arthrodensis | Device | 3D printing personalized plate |
Primary outcome
Operation time
Time frame: Intraoperative
Operation time for internal fixation
2 secondary outcomes
Postoperative subtalar VAS score
Time frame: Postoperative 1,6,12 months
Fusion rate
Time frame: Postoperative 1,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 33426066Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojun Duan, MD principal investigator
Southwest Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3d printing personalized plate in people with Ankle Injuries, run by Southwest Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojun Duan, MD (86-23-68765290, duanxiaojun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03152916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.