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Clinical Trials/NCT05011734
NCT05011734
Completed
Not Applicable

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

Istituto Ortopedico Rizzoli1 site in 1 country16 target enrollmentNovember 3, 2021
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ConditionsScoliosis Idiopathic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scoliosis Idiopathic
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
16
Locations
1
Primary Endpoint
Evaluation of the Fast track protocol
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 3, 2021
End Date
February 6, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Surgical and clinical outcome(at baseline (Day0))

Study Sites (1)

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