Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.

Scoliosis Idiopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05011734
• Other study ID #: FAST-TRACK-IOR
• Status: Recruiting
• Start date: November 3, 2021
• Est. completion date: May 6, 2024

Study information

• Verified date: March 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Konstantinos Martikos, MD
• Phone: 051-6366
• Email: konstantinos.martikos[@]ior.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 6, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic

Intervention

Other:
• Fast Track recovery pathway
Multidisciplinary approach alongside the orthopedic surgeon

Locations

Country	Name	City	State
Italy	IRCCS Itituto Ortopedico Rizzoli	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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: 10.118 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Evaluation of the Fast track protocol	Evaluation of an intra- and post-operative fast-track protocol in terms of blood loss	at baseline (Day0)
Primary	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	Surgical and clinical outcome	evaluation of the hemocytometric examination (performed as per normal clinical practice).	at baseline (Day0)
Secondary	Surgical and clinical outcome	evaluation of the main circulating inflammatory mediators.	at baseline (Day0)
Secondary	Surgical and clinical outcome	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)