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Completed

NCT Number: NCT04671147

Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis

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

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Key information

Conditions

Scoliosis Idiopathic

Age range

10 year–40 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative traction

Procedure

Compare two methods of preoperative traction (Cotrel traction exercises and skull tongs femoral traction)

Primary outcomes

  1. Radiologic change

    Time frame: - Baseline - Immediately after 2 weeks of preoperative traction - immediately after the correction surgery

    Preoperative, post traction and postoperative xray

Secondary outcomes

  1. Blood loss

    Time frame: Intraoperative

    The amount of blood loss during the correction surgery

  2. Duration of surgery

    Time frame: Intraoperative

    The time required to perform the correction surgery

  3. Number of instrumented levels

    Time frame: Intraoperative

    the number of vertebrae instrumented during the correction surgery

Sponsors and collaborators

Lead sponsor

Indonesian Orthopaedic Association

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 17, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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