Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.

November 5, 2024 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40136
        • IRCCS Itituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adolescents with idiopathic scoliosis treatable by surgical procedure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline (Day0)
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
at baseline (Day0)
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
at baseline (Day0)
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.
at baseline (Day0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical and clinical outcome
Time Frame: at baseline (Day0)
evaluation of the hemocytometric examination (performed as per normal clinical practice).
at baseline (Day0)
Surgical and clinical outcome
Time Frame: at baseline (Day0)
evaluation of the main circulating inflammatory mediators.
at baseline (Day0)
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.
at baseline (Day0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2021

Primary Completion (Actual)

February 5, 2024

Study Completion (Actual)

February 6, 2024

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

August 13, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAST-TRACK-IOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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