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OpenTrials
Completed

NCT Number: NCT03947541

Utility of Postoperative Bracing

The study is being done to assess if the use of bracing helps improve quality of life of patients that are undergoing a spinal fusion for deformity.

If the participant agrees to be in this trial they will be randomly assigned (like the flip of a coin) to receive either brace treatment or non-brace treatment.

Regardless of what treatment group the participants are in, they will undergo surgery as planned. After surgery, patients in both groups will be treated per standard of care.

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Key information

Conditions

Postoperative Bracing for Spinal Deformity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The principal investigator's new or returning patients
  • Adults 18 to 80 years of old
  • Undergoing a spinal fusion procedure of greater than or equal to 5 levels for the purpose of correcting idiopathic spinal deformity

Exclusion criteria

  • Patients who are undergoing a spinal fusion for other reasons besides deformity
  • Patients who are unable to provide consent or fill out survey questionnaires
  • Patients who have brace-prohibitive body habitus
  • Patients who are unable to obtain standing AP and lateral 3-foot standing scoliosis x-rays

Treatment and study plan

Thoracolumbosacral (TLSO) brace

Other

Patients will be required to wear the TLSO brace when out of bed, beginning on postoperative day 2 through 6 week follow-up period.

No Bracing

Other

Participants will not wear a brace in the study.

Primary outcomes

  1. Change in Oswestry Disability Index (ODI) score

    Time frame: Baseline, 3 months, 6 months, 12 months and 24 months

    Scores from 0 to 5, and the total is added and multiplied by 2. Therefore, the ODI ranges from 0 to 100. A higher score on the ODI indicates a more severe disability.

Secondary outcomes

  1. Changes in Scoliosis Research Society Outcomes Questionnaire (SRS-22 and SRS-30)

    Time frame: Baseline, 3 months, 6 months, 12 months and 24 months

    Measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The maximum score in each domain is 5 and minimum score is 1, with higher scores representing greater patient quality of life.

  2. Change in Visual Analogue Scale (VAS)

    Time frame: Baseline, 3 months, 6 months, 12 months and 24 months

    Scale from 0 to 10, 0 being no pain and 10 being worst pain imaginable.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Utility of Postoperative Bracing: A Single-institution, Randomized-control Trial Comparing Brace to No-brace for Patients Undergoing Long-segment Fusion for Spinal Deformity

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 13, 2019
Registry last updated
Feb 23, 2022

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.