Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis

Scoliosis Idiopathic Clinical Trial

Official title:

Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis: A Comparison Between Skull Tongs-Femoral Traction and Cotrel Longitudinal Traction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671147
• Other study ID #: IndonesianOrthopaedic
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2020
• Source: Indonesian Orthopaedic Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic

Intervention

Procedure:
• Preoperative traction
Compare two methods of preoperative traction (Cotrel traction exercises and skull tongs femoral traction)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesian Orthopaedic Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiologic change	Preoperative, post traction and postoperative xray	- Baseline - Immediately after 2 weeks of preoperative traction - immediately after the correction surgery
Secondary	Blood loss	The amount of blood loss during the correction surgery	Intraoperative
Secondary	Duration of surgery	The time required to perform the correction surgery	Intraoperative
Secondary	Number of instrumented levels	the number of vertebrae instrumented during the correction surgery	Intraoperative