Short-Term Preoperative Traction Method for Rigid and Sev... | NCT04671147

Studies
Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis

NCT04671147

Sponsor

Indonesian Orthopaedic Association

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Scoliosis Idiopathic

Interventions

Preoperative traction

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Nov 28, 2020

First Submission Date that Met QC Criteria

Dec 15, 2020

First Posted Date

Dec 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2020

Last Update Posted Date

Dec 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yoshi Pratama Djaja, Principal Investigator, Indonesian Orthopaedic AssociationPrincipal Investigator

Lead Sponsor

Indonesian Orthopaedic AssociationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Skull tong femoral traction			Procedure: Preoperative traction
Cotrell longitudinal traction			Procedure: Preoperative traction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preoperative traction	Procedure	Compare two methods of preoperative traction (Cotrel traction exercises and skull tongs femoral traction)	Cotrell longitudinal traction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiologic change	Preoperative, post traction and postoperative xray	- Baseline - Immediately after 2 weeks of preoperative traction - immediately after the correction surgery

Secondary Outcomes

Measure	Description	Time Frame
Blood loss	The amount of blood loss during the correction surgery	Intraoperative
Duration of surgery	The time required to perform the correction surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

other types of scoliosis (neuromuscular scoliosis, congenital scoliosis, etc.)
intradural abnormalities (diastomatomyelia, tethered cord, etc)
history of previous spine surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

severe (>80o) and rigid scoliosis patients who underwent preoperative traction before correction surgery from 2016 to 2018

Sampling Method

Non-Probability Sample