Deformity; BoneNCT04423835
Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children
An observational study of Deformity; Bone, run by Children's Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Humeral osteotomy is the most effective method for evident cubitus varus correction in children. Several osteotomy methods and fixation materials have been developed in the past. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Deformity; Bone
- What is being tested?
- Paley's Principle osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 Jan 2020
- Phase
- Observational
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: All the patients were performed surgery between July 2015 and October 2017
Who may be able to join
- surgery performed over 6 months after the occurrence of SHFs
- difference in flexion angles of the affected and unaffected limbs of >15 degrees
- recovery of elbow function pre-ostomy
Who cannot join
- any other surgical approach used
- consent not obtained from the patient's guardians
- incomplete follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
About this study
Official title: Applying Paley's Principles to Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children
Humeral osteotomy is the most effective method for evident cubitus varus correction in children. Several osteotomy methods and fixation materials have been developed in the past. By applying the principles of deformity correction described by Paley, the investigators describe a novel corrective technique for cubitus varus involving lateral osteotomy using Kirschner wires.
Read the detailed description
Supracondylar humerus fractures (SHFs) account for approximately 10% of all pediatric fractures in children. Poorly treated SHFs can lead to the most common cubitus varus deformity especially in patients treated conservatively. The cosmetic aspect of this deformity is the main concern of patients, together with reduced remodeling ability. Inevitably, surgery is the first choice for such patients. Several osteotomy techniques and fixation materials have been developed in the last several decades. With the advent of three-dimensional printing techniques and computed tomography reconstruction methods, more accurate computing designs have been applied in the correction of cubitus varus. These techniques make the surgery more complex and require the performance of computed tomography (CT), resulting in high radiation exposure in children. Paley described the principles of deformity correction that are widely used for the lower limbs. These principles represent an alternative with easy application without the need of CT, with less occurrence of prominence and good cosmetic outcome. According to the Paley principles, all the vertex of the triangular osteotomy should site on the center of rotation of angulation (CORA) line, by doing this, the gun-butt deformity was corrected perfectly. More importantly, they help to accurately correct the anatomic axis of the upper limb. According to our knowledge, this is the first study describes the lateral closing wedge osteotomy for correction cubitus varus deformity in children by applying Paley's principles and fixation with K-wires.
Taken together, the investigators aimed at verifying the feasibility of Paley's principles for deformity correction to treat cubitus varus in children.
- Conditions
- Deformity; Bone
- Being tested
- Paley's Principle osteotomy
- Keywords
- cubitus varus, supracondylar humerus fracture, osteotomy
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paley's Principle osteotomyProcedure or surgery
Also called Applying Paley's Principles to Lateral Closing Wedge Osteotomy
. The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs. An isosceles triangle template was used for osteotomy, and the medial cortex was left intact. K-wires were used to fix the osteotomy laterally.
| Study group | Role | What they receive |
|---|---|---|
| lateral closing osteotomy for cubitus varus deformity | The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs. Receives: Procedure: Paley's Principle osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow appearance
elbows were evaluated using radiography and appearence
Measured: 3th month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jan 2015
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deformity; BoneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuxi Su, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423835
- Sponsor's protocol ID
- CQMU20200026
- Status last verified
- Jun 2020
- First submitted
- 6 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Paley's Principles to Lateral Closing Wedge Osteotomy for Cubitus Varus Deformity in Children
- ClinicalTrials.gov ID
- NCT04423835
- Acronym / sponsor ID
- CQMU20200026
- Conditions
- Deformity; Bone
- Keywords
- cubitus varus, supracondylar humerus fracture, osteotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 9 Jun 2020 (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.
Humeral osteotomy is the most effective method for evident cubitus varus correction in children. Several osteotomy methods and fixation materials have been developed in the past. By applying the principles of deformity correction described by Paley, the investigators describe a novel corrective technique for cubitus varus involving lateral osteotomy using Kirschner wires.
Detailed description
Supracondylar humerus fractures (SHFs) account for approximately 10% of all pediatric fractures in children. Poorly treated SHFs can lead to the most common cubitus varus deformity especially in patients treated conservatively. The cosmetic aspect of this deformity is the main concern of patients, together with reduced remodeling ability. Inevitably, surgery is the first choice for such patients. Several osteotomy techniques and fixation materials have been developed in the last several decades. With the advent of three-dimensional printing techniques and computed tomography reconstruction methods, more accurate computing designs have been applied in the correction of cubitus varus. These techniques make the surgery more complex and require the performance of computed tomography (CT), resulting in high radiation exposure in children. Paley described the principles of deformity correction that are widely used for the lower limbs. These principles represent an alternative with easy application without the need of CT, with less occurrence of prominence and good cosmetic outcome. According to the Paley principles, all the vertex of the triangular osteotomy should site on the center of rotation of angulation (CORA) line, by doing this, the gun-butt deformity was corrected perfectly. More importantly, they help to accurately correct the anatomic axis of the upper limb. According to our knowledge, this is the first study describes the lateral closing wedge osteotomy for correction cubitus varus deformity in children by applying Paley's principles and fixation with K-wires.
Taken together, the investigators aimed at verifying the feasibility of Paley's principles for deformity correction to treat cubitus varus in children.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lateral closing osteotomy for cubitus varus deformity | – | Procedure: Paley's Principle osteotomyThe osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All the patients were performed surgery between July 2015 and October 2017
Key inclusion criteria (3 listed)
- surgery performed over 6 months after the occurrence of SHFs
- difference in flexion angles of the affected and unaffected limbs of >15 degrees
- recovery of elbow function pre-ostomy
Key exclusion criteria (3 listed)
- any other surgical approach used
- consent not obtained from the patient's guardians
- incomplete follow-up
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 |
|---|---|---|
| Paley's Principle osteotomyAlso: Applying Paley's Principles to Lateral Closing Wedge Osteotomy. The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs. An isosceles triangle template was used for osteotomy, and the medial cortex was left intact. K-wires were used to fix the osteotomy laterally. | Procedure or surgery | lateral closing osteotomy for cubitus varus deformity |
Primary outcome
Elbow appearance
Time frame: 3th month after surgery
elbows were evaluated using radiography and appearence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deformity; Bone, run by Children's Hospital of Chongqing Medical University 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 3 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: finished, as of the sponsor's last update on 11 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elbow appearance (time frame: 3th month after surgery). 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 11 Jun 2020.