Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis

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

Study Overview

• Status: Completed
• Conditions: Scoliosis Idiopathic
• Intervention / Treatment: Procedure: Preoperative traction

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 36 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Skull tong femoral traction	Procedure: Preoperative traction; Compare two methods of preoperative traction (Cotrel traction exercises and skull tongs femoral traction)
Cotrell longitudinal traction	Procedure: Preoperative traction; Compare two methods of preoperative traction (Cotrel traction exercises and skull tongs femoral traction)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	Intraoperative
Number of instrumented levels	the number of vertebrae instrumented during the correction surgery	Intraoperative

Collaborators and Investigators

• Sponsor: Indonesian Orthopaedic Association

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: November 28, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: IndonesianOrthopaedic

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No