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Completed

NCT Number: NCT05011734

Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.

the study will evaluate the clinical outcomes of an intra- and postoperative fast-track protocol in patients undergoing instrumented posterior arthrodesis surgery for adolescent idiopathic scoliosis.

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Key information

Conditions

Scoliosis Idiopathic Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Itituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages 14-18 years
  • iagnosis of adolescent idiopathic scoliosis requiring an instrumented posterior arthrodesis surgical procedure
  • Males and females.

Exclusion criteria

  • spinal infection
  • neoplastic diseases
  • heart disease
  • hypersensitivity to tranexamic acid
  • history of coagulopathy and/or previous thromboembolic events
  • severe renal failure

Treatment and study plan

Fast Track recovery pathway

Other

Multidisciplinary approach alongside the orthopedic surgeon

Primary outcomes

  1. Evaluation of the Fast track protocol

    Time frame: at baseline (Day0)

    Evaluation of an intra- and post-operative fast-track protocol in terms of postoperative pain management.

  2. Evaluation of the Fast track protocol

    Time frame: at baseline (Day0)

    Evaluation of an intra- and post-operative fast-track protocol in terms of duration/times of hospitalization

  3. Evaluation of the Fast track protocol

    Time frame: at baseline (Day0)

    Evaluation of an intra- and post-operative fast-track protocol in terms of blood loss

  4. Evaluation of the Fast track protocol

    Time frame: at baseline (Day0)

    Evaluation of an intra- and post-operative fast-track protocol in terms of patient education in early recovery of function.

Secondary outcomes

  1. Surgical and clinical outcome

    Time frame: at baseline (Day0)

    evaluation of the hemocytometric examination (performed as per normal clinical practice).

  2. Surgical and clinical outcome

    Time frame: at baseline (Day0)

    evaluation of the main circulating inflammatory mediators.

  3. Surgical and clinical outcome

    Time frame: at baseline (Day0)

    evaluation of culture examinations on the surgical wound drainage fluid and microstructural analysis of the surgical drainage tube by scanning electron microscope.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Rapid Postoperative Recovery (Fast-track) Pathway in Adolescent Idiopathic Scoliosis: a Pilot Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2021
Registry last updated
Nov 6, 2024

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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