Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.

Completed

• Conditions: Scoliosis Idiopathic

• Registration Number: NCT05011734
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-18
• Study Start: 2021-11-03
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the Fast track protocol	at baseline (Day0)	Evaluation of an intra- and post-operative fast-track protocol in terms of patient education in early recovery of function.

Secondary Outcome Measures

Name	Time	Method
Surgical and clinical outcome	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.

Trial Locations

Locations (1)

IRCCS Itituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy