Congenital Scoliosis Due to Bony MalformationNCT05190393
Comparison of Techniques Between Concave Distraction and Convex Resection in the Treatment of Congenital Cervical Scoliosis
An observational study of Congenital Scoliosis Due to Bony Malformation and Cervical Scoliosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
To treat congenital cervical scoliosis, previous literature introduced surgical technique, like hemivertebra resection by anterior and posterior approach. Although this technique is effective, it has a lot of disadvantages. So investigators introduce another surgical technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Scoliosis Due to Bony Malformation, Cervical Scoliosis
- What is being tested?
- hemivertebra resection on convex side and concave distraction group
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 1 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with congenital cervical scoliosis were enrolled.
Who may be able to join
- the presence of torticollis caused by congenital cervical scoliosis (defined as a Cobb angle of >10°)
- operation and follow-up were performed in our hospital
Who cannot join
- Patients with other causes of torticollis appearance, such as muscular torticollis, ocular torticollis, neurogenic torticollis, etc.
- Patients with other spinal deformity or disease, such as cervical kyphosis or kyphoscoliosis, congenital deformity of middle and lower thoracic vertebra, lumbar vertebra, ankylosing spondylitis, severe ossification of cervical posterior longitudinal ligament, etc.
- Cervical infectious diseases, cervical primary or metastatic tumor
- Have a history of spinal trauma or surgery
- Imaging data are incomplete or of poor quality.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
To treat congenital cervical scoliosis, previous literature introduced surgical technique, like hemivertebra resection by anterior and posterior approach. Although this technique is effective, it has a lot of disadvantages. So investigators introduce another surgical technique.
Read the detailed description
Although hemivertebra resection technique can obtain satisfactory clinical outcome, it has its disadvantages. Because of the presence of vertebral arteries, the procedure of cervical hemivertebra resection is not only difficult and risky, but also time and labor consuming. The operation is a great challenge to the skill, physical strength and energy of the surgical team. Meanwhile, hemivertebra resection and compression on convex side may lead to iatrogenic foraminal stenosis and increase the incidence of nerve root palsy at the corresponding segment after surgery. The shortening of the convex side may further aggravate the patient's existing short neck deformity, which is not conducive to the recovery of patient's appearance. Therefore, our department pioneer a new surgical technique to avoid hemivertebra resection in 2015, which is distraction and lateral opening on concave side. This technique extends the concave side through intervertebral space where the concave apex locates or adjacent intervertebral space to achieve the purpose of scoliosis correction. The avoidance of hemivertebra resection significantly reduces the difficulty and risk of the surgery. This procedure tries to make up for the patient's congenital anatomical deficiency and lengthen the concave side. Although there is no need to expose vertebral artery, preoperative CTA(computed tomography angiography) should be performed routinely to determine whether there is abnormality in vertebral artery and whether it will interfere with the distraction on concave side and the placement of prosthesis.
- Being tested
- hemivertebra resection on convex side, concave distraction group
- Keywords
- Congenital cervical scoliosis, hemivertebra resection, distraction and lateral opening, spinal fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemivertebra resection on convex sideProcedure or surgery
Patients were used hemivertebra resection procedure to treat congenital cervical scoliosis.
concave distraction groupProcedure or surgery
Patients were used distraction and lateral opening procedure to treat congenital cervical scoliosis.
| Study group | Role | What they receive |
|---|---|---|
| Convex resection group | Patients were used hemivertebra resection procedure on convex side to treat congenital cervical scoliosis. Receives: Procedure: hemivertebra resection on convex side | |
| Concave distraction group | Patients were used distraction and lateral opening procedure on concave side to treat congenital cervical scoliosis, without hemivertebra resection. Receives: Procedure: concave distraction group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the structural Cobb angle
the large curve in the segments with vertebral deformities causing clinical asymmetry or head deviation and needs to be surgically corrected
Measured: one week pre operation
the structural Cobb angle
the large curve in the segments with vertebral deformities causing clinical asymmetry or head deviation and needs to be surgically corrected
Measured: one week after surgery
the structural Cobb angle
the large curve in the segments with vertebral deformities causing clinical asymmetry or head deviation and needs to be surgically corrected
Measured: through study completion, an average of 1 year
distal compensatory Cobb angle
the small curve without vertebral deformities
Measured: one week pre operation
distal compensatory Cobb angle
the small curve without vertebral deformities
Measured: one week after surgery
distal compensatory Cobb angle
the small curve without vertebral deformities
Measured: through study completion, an average of 1 year
mandibular incline
the angle between the horizontal line and the line through the mandibular angles on both sides
Measured: one week pre operation
mandibular incline
the angle between the horizontal line and the line through the mandibular angles on both sides
Measured: one week after surgery
mandibular incline
the angle between the horizontal line and the line through the mandibular angles on both sides
Measured: through study completion, an average of 1 year
clavicle angle
the angle between the horizontal line and the line through the clavicular distal end on both sides
Measured: one week pre operation
clavicle angle
the angle between the horizontal line and the line through the clavicular distal end on both sides
Measured: one week after surgery
clavicle angle
the angle between the horizontal line and the line through the clavicular distal end on both sides
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
blood loss
blood loss during operation
Measured: during operation
surgical time duration
surgical time duration during operation
Measured: during operation
complications
complications during and after operation
Measured: peroperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Jan 2016
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Scoliosis Due to Bony MalformationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Sun, MD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190393
- Sponsor's protocol ID
- PUTHCCS
- Status last verified
- Jan 2016
- First submitted
- 6 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- 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 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Techniques Between Concave Distraction and Convex Resection in the Treatment of Congenital Cervical Scoliosis
- ClinicalTrials.gov ID
- NCT05190393
- Acronym / sponsor ID
- PUTHCCS
- Keywords
- Congenital cervical scoliosis, hemivertebra resection, distraction and lateral opening, spinal fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 13 Jan 2022 (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.
To treat congenital cervical scoliosis, previous literature introduced surgical technique, like hemivertebra resection by anterior and posterior approach. Although this technique is effective, it has a lot of disadvantages. So investigators introduce another surgical technique.
Detailed description
Although hemivertebra resection technique can obtain satisfactory clinical outcome, it has its disadvantages. Because of the presence of vertebral arteries, the procedure of cervical hemivertebra resection is not only difficult and risky, but also time and labor consuming. The operation is a great challenge to the skill, physical strength and energy of the surgical team. Meanwhile, hemivertebra resection and compression on convex side may lead to iatrogenic foraminal stenosis and increase the incidence of nerve root palsy at the corresponding segment after surgery. The shortening of the convex side may further aggravate the patient's existing short neck deformity, which is not conducive to the recovery of patient's appearance. Therefore, our department pioneer a new surgical technique to avoid hemivertebra resection in 2015, which is distraction and lateral opening on concave side. This technique extends the concave side through intervertebral space where the concave apex locates or adjacent intervertebral space to achieve the purpose of scoliosis correction. The avoidance of hemivertebra resection significantly reduces the difficulty and risk of the surgery. This procedure tries to make up for the patient's congenital anatomical deficiency and lengthen the concave side. Although there is no need to expose vertebral artery, preoperative CTA(computed tomography angiography) should be performed routinely to determine whether there is abnormality in vertebral artery and whether it will interfere with the distraction on concave side and the placement of prosthesis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convex resection group | – | Procedure: hemivertebra resection on convex sidePatients were used hemivertebra resection procedure on convex side to treat congenital cervical scoliosis. |
| Concave distraction group | – | Procedure: concave distraction groupPatients were used distraction and lateral opening procedure on concave side to treat congenital cervical scoliosis, without hemivertebra resection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with congenital cervical scoliosis were enrolled.
Key inclusion criteria (2 listed)
- the presence of torticollis caused by congenital cervical scoliosis (defined as a Cobb angle of >10°)
- operation and follow-up were performed in our hospital
Key exclusion criteria (5 listed)
- Patients with other causes of torticollis appearance, such as muscular torticollis, ocular torticollis, neurogenic torticollis, etc.
- Patients with other spinal deformity or disease, such as cervical kyphosis or kyphoscoliosis, congenital deformity of middle and lower thoracic vertebra, lumbar vertebra, ankylosing spondylitis, severe ossification of cervical posterior longitudinal ligament, etc.
- Cervical infectious diseases, cervical primary or metastatic tumor
- Have a history of spinal trauma or surgery
- Imaging data are incomplete or of poor quality.
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 |
|---|---|---|
| hemivertebra resection on convex sidePatients were used hemivertebra resection procedure to treat congenital cervical scoliosis. | Procedure or surgery | Convex resection group |
| concave distraction groupPatients were used distraction and lateral opening procedure to treat congenital cervical scoliosis. | Procedure or surgery | Concave distraction group |
Primary outcome
the structural Cobb angle
Time frame: one week pre operation
the large curve in the segments with vertebral deformities causing clinical asymmetry or head deviation and needs to be surgically corrected
the structural Cobb angle
Time frame: one week after surgery
the large curve in the segments with vertebral deformities causing clinical asymmetry or head deviation and needs to be surgically corrected
the structural Cobb angle
Time frame: through study completion, an average of 1 year
the large curve in the segments with vertebral deformities causing clinical asymmetry or head deviation and needs to be surgically corrected
distal compensatory Cobb angle
Time frame: one week pre operation
the small curve without vertebral deformities
distal compensatory Cobb angle
Time frame: one week after surgery
the small curve without vertebral deformities
distal compensatory Cobb angle
Time frame: through study completion, an average of 1 year
the small curve without vertebral deformities
mandibular incline
Time frame: one week pre operation
the angle between the horizontal line and the line through the mandibular angles on both sides
mandibular incline
Time frame: one week after surgery
the angle between the horizontal line and the line through the mandibular angles on both sides
mandibular incline
Time frame: through study completion, an average of 1 year
the angle between the horizontal line and the line through the mandibular angles on both sides
clavicle angle
Time frame: one week pre operation
the angle between the horizontal line and the line through the clavicular distal end on both sides
clavicle angle
Time frame: one week after surgery
the angle between the horizontal line and the line through the clavicular distal end on both sides
clavicle angle
Time frame: through study completion, an average of 1 year
the angle between the horizontal line and the line through the clavicular distal end on both sides
3 secondary outcomes
blood loss
Time frame: during operation
surgical time duration
Time frame: during operation
complications
Time frame: peroperative period
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 13 Jan 2022.
- Individual participant dataSharing planned: No
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.
Yu Sun, MD study chair
Peking University Third Hospital
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 Congenital Scoliosis Due to Bony Malformation and Cervical Scoliosis, run by Peking University Third 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 2 inclusion and 5 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 13 Jan 2022. 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?
the structural Cobb angle (time frame: one week pre operation). The study lists 12 primary outcomes in all. 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 13 Jan 2022.