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CompletedNCT04671147Updated Dec 17, 2020

Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis

An observational study in Scoliosis Idiopathic, sponsored by Indonesian Orthopaedic Association. Completed. Open to participants aged 10 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by Indonesian Orthopaedic Association · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
10 Years to 40 Years
Sex
All
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Study 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

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Conditions studied

  • Scoliosis Idiopathic

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03

In context

Scoliosis

594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.

This study's enrollment of 30 is below the median of 89 across 233 observational studies indexed under Scoliosis.

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Lead sponsor

This is the only study on the registry with Indonesian Orthopaedic Association as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Skull tong femoral traction

    Procedure: Preoperative traction

  • Cotrell longitudinal traction

    Procedure: Preoperative traction

Interventions

  • ProcedurePreoperative traction

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

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What researchers measure

Primary outcomes

  1. Radiologic change

    Preoperative, post traction and postoperative xray

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

Secondary outcomes

  1. Blood loss

    The amount of blood loss during the correction surgery

    Time frame: Intraoperative

  2. Duration of surgery

    The time required to perform the correction surgery

    Time frame: Intraoperative

  3. Number of instrumented levels

    the number of vertebrae instrumented during the correction surgery

    Time frame: Intraoperative

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04671147
Lead sponsor
Indonesian Orthopaedic Association
Responsible party
Yoshi Pratama Djaja (Principal Investigator, Indonesian Orthopaedic Association) — Principal investigator
First posted
Dec 17, 2020
Start date
Jan 1, 2016
Primary completion
Dec 31, 2018
Completion
Dec 31, 2019
Last update
Dec 17, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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