Congenital Pseudarthrosis of TibiaNCT03257826
The Effect of Percutaneous Kirschner Wire Technique in Management of CPT Under One Year Old
A study testing kirschner wire in people with Congenital Pseudarthrosis of Tibia, run by Hunan Children's Hospital at 1 site in China.
Trial summary
The aim of this study was to investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. This study was to determine the union rates of congenital pseudarthrosis in children operated before 1 year of age to identify growth… Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Congenital Pseudarthrosis of Tibia
- What is being tested?
- kirschner wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2015to 1 Dec 2022
- 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 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All patients did not undergo procedures
- Patients with Crawford type IV CPT treated with Percutaneous Kirschner wire techniques
- The age during surgery was less than 12 months old
Who cannot join
- Patients with pseudarthrosis of tibia caused by trauma,infection, etc
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Kun Liu
Changsha, Hunan, 417000
Kun Liu, MD, 008615084796158, lk998@sina.com
About this study
Official title: The Effect of Percutaneous Kirschner Wire Technique in Management of Congenital Pseudarthrosis of Tibia Under One Year Old
The aim of this study was to investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. This study was to determine the union rates of congenital pseudarthrosis in children operated before 1 year of age to identify growth abnormalities in the affected limb ,including ankle valgus,tibia valgus,and shortening.
Read the detailed description
Currently, the timing of surgery for congenital pseudarthrosis of the tibia is a controversial issue. The investigators use percutaneous kirschner wire technique to manage the Congenital Pseudarthrosis of Tibia in children younger than 1 year of age.To investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. Bone uion rate,average time of healing, ankle valgus, limb length discrepancy, tibia axis alignment are recorded and evaluated.
- Conditions
- Congenital Pseudarthrosis of Tibia
- Being tested
- kirschner wire
- Keywords
- congenital pseudarthrosis of the tibia, age of surgery, Percutaneous Kirschner wire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kirschner wireDevice
retrograde percutaneous kirschner wire was applied to stabilize the tibia.
| Study group | Role | What they receive |
|---|---|---|
| surgery | Experimental | Percutaneous Kirschner wire Receives: Device: kirschner wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary union score (range,4-12 score)
X ray score from tibia pseudarthrosis in anterior and posterior (AP )and lateral X ray. ("RUST" score:radiographic union scoring system for tibial fracture healing)
Measured: 9 months post-operation
Secondary outcomes (4)
Refracture（Cortical discontinuity)
Refracture was defined as an obvious fracture（Cortical discontinuity) on a plain radiograph,following the union at the site of the tibia.
Measured: 0.5 , 1,2,3,4,5,6,7,8,9,10 years after the fracture is healed
Residual Deformity-proximal tibia angulation(range,0°-90°)
measurement of the angulation of proximal tibia in anterior and posterior (AP )and lateral X ray.Proximal tibial valgus is created by the intersection of a line parallel to the proximal physis and another line along the axis of the proximal third of diaphysis in the tibia.
Measured: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]
Residual Deformity-Limb length discrepancy
measurement of the length difference of both tibia in AP and lateral X ray.Picture Archiving and Communication System (PACS) is used to measure the length of the tibia (The investigators measure the distance between the midpoint of the proximal tibial epiphyseal plate and the midpoint of distal tibia epiphyseal plate).
Measured: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Residual Deformity-ankle valgus angulation(range,0°-90°)
measurement of the angulation between the distal tibia and ankle joint.Ankle valgus is assessed by the tibiotalar angle measured at the intersection of the mid-diaphyseal line of the tibia and a line drawn across the flat subchondral line of the talar dome.
Measured: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 Aug 2015
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Pseudarthrosis of TibiaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Guangzhou Women and Children's Medical Center, Shenzhen Children's Hospital, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Women and Children's Medical Center, Foshan Hospital of Traditional Chinese Medicine, Dalian Children's Hospital, Children's Hospital of Chongqing Medical University, Kunming Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Haibo Mei, MD, Study director, Hunan Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257826
- Sponsor's protocol ID
- HN04
- Status last verified
- Oct 2020
- First submitted
- 15 Aug 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Percutaneous Kirschner Wire Technique in Management of Congenital Pseudarthrosis of Tibia Under One Year Old
- ClinicalTrials.gov ID
- NCT03257826
- Acronym / sponsor ID
- HN04
- Conditions
- Congenital Pseudarthrosis of Tibia
- Keywords
- congenital pseudarthrosis of the tibia, age of surgery, Percutaneous Kirschner wire
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hunan Children's HospitalOther government
- Collaborators
- Guangzhou Women and Children's Medical Center, Shenzhen Children's Hospital, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan Women and Children's Medical Center, Foshan Hospital of Traditional Chinese Medicine, Dalian Children's Hospital, Children's Hospital of Chongqing Medical University, Kunming Children's Hospital
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 22 Aug 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.
The aim of this study was to investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. This study was to determine the union rates of congenital pseudarthrosis in children operated before 1 year of age to identify growth abnormalities in the affected limb ,including ankle valgus,tibia valgus,and shortening.
Detailed description
Currently, the timing of surgery for congenital pseudarthrosis of the tibia is a controversial issue. The investigators use percutaneous kirschner wire technique to manage the Congenital Pseudarthrosis of Tibia in children younger than 1 year of age.To investigate the effect of percutaneous kirschner wire in management of Congenital Pseudarthrosis of Tibia in children younger than 1 year of age. Bone uion rate,average time of healing, ankle valgus, limb length discrepancy, tibia axis alignment are recorded and evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery | Experimental | Device: kirschner wirePercutaneous Kirschner wire |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All patients did not undergo procedures
- Patients with Crawford type IV CPT treated with Percutaneous Kirschner wire techniques
- The age during surgery was less than 12 months old
Key exclusion criteria (1 listed)
- Patients with pseudarthrosis of tibia caused by trauma,infection, etc
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 |
|---|---|---|
| kirschner wireretrograde percutaneous kirschner wire was applied to stabilize the tibia. | Device | surgery |
Primary outcome
Primary union score (range,4-12 score)
Time frame: 9 months post-operation
X ray score from tibia pseudarthrosis in anterior and posterior (AP )and lateral X ray. ("RUST" score:radiographic union scoring system for tibial fracture healing)
4 secondary outcomes
Refracture（Cortical discontinuity)
Time frame: 0.5 , 1,2,3,4,5,6,7,8,9,10 years after the fracture is healed
Residual Deformity-proximal tibia angulation(range,0°-90°)
Time frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation ]
Residual Deformity-Limb length discrepancy
Time frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Residual Deformity-ankle valgus angulation(range,0°-90°)
Time frame: pre-operation and 0.5 , 1,2,3,4,5,6,7,8,9,10 years post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
Related trials for Congenital Pseudarthrosis of Tibia
RecruitingPhase 3
A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
Congenital Pseudarthrosis of Tibia
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.
Haibo Mei, MD study director
Hunan Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kirschner wire in people with Congenital Pseudarthrosis of Tibia, run by Hunan Children's Hospital 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 3 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 22 Oct 2020. 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 Kun Liu, MD (008615084796158, lk998@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary union score (range,4-12 score) (time frame: 9 months post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2020.