Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.

NCT05011734 | Completed

• 1 other identifier: FAST-TRACK-IOR
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scoliosis Idiopathic

Keywords

Scoliosis

Outcome Measures

Primary Outcomes (4)

• Evaluation of the Fast track protocol

  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

  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

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

  at baseline (Day0)

• Evaluation of the Fast track protocol

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

  at baseline (Day0)

Secondary Outcomes (3)

• Surgical and clinical outcome

  at baseline (Day0)

• Surgical and clinical outcome

  at baseline (Day0)

• Surgical and clinical outcome

  at baseline (Day0)

Interventions

Fast Track recovery pathway OTHER

Multidisciplinary approach alongside the orthopedic surgeon

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with idiopathic scoliosis treatable by surgical procedure

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Itituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

Related Publications (3)

• Wang H, Tetteroo D, Arts JJC, Markopoulos P, Ito K. Quality of life of adolescent idiopathic scoliosis patients under brace treatment: a brief communication of literature review. Qual Life Res. 2021 Mar;30(3):703-711. doi: 10.1007/s11136-020-02671-7. Epub 2020 Oct 24.

  PMID: 33098493 RESULT

• Lee CS, Merchant S, Chidambaran V. Postoperative Pain Management in Pediatric Spinal Fusion Surgery for Idiopathic Scoliosis. Paediatr Drugs. 2020 Dec;22(6):575-601. doi: 10.1007/s40272-020-00423-1. Epub 2020 Oct 23.

  PMID: 33094437 RESULT

• Seki H, Ideno S, Ishihara T, Watanabe K, Matsumoto M, Morisaki H. Postoperative pain management in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis: a narrative review. Scoliosis Spinal Disord. 2018 Sep 12;13:17. doi: 10.1186/s13013-018-0165-z. eCollection 2018.

  PMID: 30214945 RESULT

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 18, 2021
• Study Start: November 3, 2021
• Primary Completion: February 5, 2024
• Study Completion: February 6, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)