Scoliosis IdiopathicNCT04671147
Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis
An observational study of Scoliosis Idiopathic, run by Indonesian Orthopaedic Association.
Trial summary
The investigators collected retrospective data of severe (>80o) and rigid scoliosis patients who underwent preoperative traction before correction surgery from 2016 to 2018. The first group consisted of patients who underwent Cotrel traction exercises and second group underwent continuous-progressively increasing… Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Preoperative traction
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2019
- 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 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: severe (>80o) and rigid scoliosis patients who underwent preoperative traction before correction surgery from 2016 to 2018
Who may be able to join
- adolescence/adult idiopathic scoliosis;
- severe and rigid scoliosis (defined as Cobb angle more than 80° and flexibility index less than 25%);
- either skull tongs-femoral traction or Cotrel longitudinal traction used in the preoperative time period
Who cannot join
- other types of scoliosis (neuromuscular scoliosis, congenital scoliosis, etc.)
- intradural abnormalities (diastomatomyelia, tethered cord, etc)
- history of previous spine surgery
About this study
Official title: Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis: A Comparison Between Skull Tongs-Femoral Traction and Cotrel Longitudinal Traction
The investigators collected retrospective data of severe (>80o) and rigid scoliosis patients who underwent preoperative traction before correction surgery from 2016 to 2018. The first group consisted of patients who underwent Cotrel traction exercises and second group underwent continuous-progressively increasing Skull Tongs Femoral Traction (STFT) traction. Posterior fusion was performed in all patients. Intraoperative parameters (blood loss, operation time and level instrumented) and radiologic change (initial, post-traction and postoperative Cobb Angle) was evaluated and analyzed
- Conditions
- Scoliosis Idiopathic
- Being tested
- Preoperative traction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative tractionProcedure or surgery
Compare two methods of preoperative traction (Cotrel traction exercises and skull tongs femoral traction)
| Study group | Role | What they receive |
|---|---|---|
| Skull tong femoral traction | Not described Receives: Procedure: Preoperative traction | |
| Cotrell longitudinal traction | Not described Receives: Procedure: Preoperative traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic change
Preoperative, post traction and postoperative xray
Measured: - Baseline - Immediately after 2 weeks of preoperative traction - immediately after the correction surgery
Secondary outcomes (3)
Blood loss
The amount of blood loss during the correction surgery
Measured: Intraoperative
Duration of surgery
The time required to perform the correction surgery
Measured: Intraoperative
Number of instrumented levels
the number of vertebrae instrumented during the correction surgery
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indonesian Orthopaedic Association
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshi Pratama Djaja, Indonesian Orthopaedic Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671147
- Sponsor's protocol ID
- IndonesianOrthopaedic
- Status last verified
- Dec 2020
- First submitted
- 28 Nov 2020
- Last updated
- 17 Dec 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 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis: A Comparison Between Skull Tongs-Femoral Traction and Cotrel Longitudinal Traction
- ClinicalTrials.gov ID
- NCT04671147
- Acronym / sponsor ID
- IndonesianOrthopaedic
- Conditions
- Scoliosis Idiopathic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indonesian Orthopaedic AssociationUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Dec 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.
The investigators collected retrospective data of severe (>80o) and rigid scoliosis patients who underwent preoperative traction before correction surgery from 2016 to 2018. The first group consisted of patients who underwent Cotrel traction exercises and second group underwent continuous-progressively increasing Skull Tongs Femoral Traction (STFT) traction. Posterior fusion was performed in all patients. Intraoperative parameters (blood loss, operation time and level instrumented) and radiologic change (initial, post-traction and postoperative Cobb Angle) was evaluated and analyzed
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skull tong femoral traction | – | Procedure: Preoperative traction |
| Cotrell longitudinal traction | – | Procedure: Preoperative traction |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- severe (>80o) and rigid scoliosis patients who underwent preoperative traction before correction surgery from 2016 to 2018
Key inclusion criteria (3 listed)
- adolescence/adult idiopathic scoliosis;
- severe and rigid scoliosis (defined as Cobb angle more than 80° and flexibility index less than 25%);
- either skull tongs-femoral traction or Cotrel longitudinal traction used in the preoperative time period
Key exclusion criteria (3 listed)
- other types of scoliosis (neuromuscular scoliosis, congenital scoliosis, etc.)
- intradural abnormalities (diastomatomyelia, tethered cord, etc)
- history of previous spine surgery
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 |
|---|---|---|
| Preoperative tractionCompare two methods of preoperative traction (Cotrel traction exercises and skull tongs femoral traction) | Procedure or surgery | Cotrell longitudinal traction, Skull tong femoral traction |
Primary outcome
Radiologic change
Time frame: - Baseline - Immediately after 2 weeks of preoperative traction - immediately after the correction surgery
Preoperative, post traction and postoperative xray
3 secondary outcomes
Blood loss
Time frame: Intraoperative
Duration of surgery
Time frame: Intraoperative
Number of instrumented levels
Time frame: Intraoperative
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 17 Dec 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic, run by Indonesian Orthopaedic Association.
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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Radiologic change (time frame: - Baseline - Immediately after 2 weeks of preoperative traction - immediately after the correction 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 17 Dec 2020.