NCT05159505

Brief Summary

The aim of this study is to compare the outcomes after scoliosis surgery before and after the implementation of an interdisciplinary juvenile scoliosis correction program in teenager based on ERAS (enhanced recovery after surgery) principles.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

December 2, 2021

Last Update Submit

December 2, 2021

Conditions

Scoliosis IdiopathicScoliosis; JuvenileScoliosisERASComplication,PostoperativeComplication of Surgical Procedure

Outcome Measures

Primary Outcomes (1)

  • type of complications

    surgery and anaesthesia complications

    up to 4 weeks after surgery

Secondary Outcomes (4)

  • Postoperative length of hospital stay

    up to 4 weeks after surgery

  • Number of Analgetics consumption

    up to 6 days after surgery

  • Time to first bowel motion

    up to 6 days after surgery

  • Time to first verticalization

    up to 6 days after surgery

Study Arms (3)

"the before" group

40 teenagers after scoliosis surgery before interdisciplinary program implementation

"the after" group 1

40 teenagers after scoliosis surgery after ERAS program implementation

"the after" group 2

40 teenagers after scoliosis surgery after ERAS and educational program implementation

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Caucasian children undergoing orthopedics surgery (e.g. spine surgery for adolescent idiopathic scoliosis).

You may qualify if:

  • patient with age \< 18 years
  • patient scheduled for idiopatic scoliosis surgery

You may not qualify if:

  • patient with age \> 18years others type of scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pomeranian Medical University

Szczecin, 70-204, Poland

RECRUITING

MeSH Terms

Conditions

ScoliosisPostoperative Complications

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jowita Biernawska, MD PhD

CONTACT

501337073lisienko@wp.pl

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 16, 2021

Study Start

December 1, 2021

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

December 16, 2021

Record last verified: 2021-12

Locations

PL(1)