Scoliosis IdiopathicNCT05011734
Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.
An observational study of Scoliosis Idiopathic, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Fast Track recovery pathway
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 3 Nov 2021to 6 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents with idiopathic scoliosis treatable by surgical procedure
Who may be able to join
- Ages 14-18 years
- iagnosis of adolescent idiopathic scoliosis requiring an instrumented posterior arthrodesis surgical procedure
- Males and females.
Who cannot join
- spinal infection
- neoplastic diseases
- heart disease
- hypersensitivity to tranexamic acid
- history of coagulopathy and/or previous thromboembolic events
- severe renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Postoperative Recovery (Fast-track) Pathway in Adolescent Idiopathic Scoliosis: a Pilot Study
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
- Being tested
- Fast Track recovery pathway
- Keywords
- Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Track recovery pathwayOther
Multidisciplinary approach alongside the orthopedic surgeon
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Fast track protocol
Evaluation of an intra- and post-operative fast-track protocol in terms of postoperative pain management.
Measured: 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
Measured: at baseline (Day0)
Evaluation of the Fast track protocol
Evaluation of an intra- and post-operative fast-track protocol in terms of blood loss
Measured: 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.
Measured: at baseline (Day0)
Secondary outcomes (3)
Surgical and clinical outcome
evaluation of the hemocytometric examination (performed as per normal clinical practice).
Measured: at baseline (Day0)
Surgical and clinical outcome
evaluation of the main circulating inflammatory mediators.
Measured: at baseline (Day0)
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.
Measured: at baseline (Day0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start3 Nov 2021
- Primary completion5 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011734
- Sponsor's protocol ID
- FAST-TRACK-IOR
- Status last verified
- Nov 2024
- First submitted
- 28 Jul 2021
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33098493Lee 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.
PubMed 33094437Seki 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.
PubMed 30214945
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Postoperative Recovery (Fast-track) Pathway in Adolescent Idiopathic Scoliosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT05011734
- Acronym / sponsor ID
- FAST-TRACK-IOR
- Conditions
- Scoliosis Idiopathic
- Keywords
- Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with idiopathic scoliosis treatable by surgical procedure
Key inclusion criteria (3 listed)
- Ages 14-18 years
- iagnosis of adolescent idiopathic scoliosis requiring an instrumented posterior arthrodesis surgical procedure
- Males and females.
Key exclusion criteria (6 listed)
- spinal infection
- neoplastic diseases
- heart disease
- hypersensitivity to tranexamic acid
- history of coagulopathy and/or previous thromboembolic events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast Track recovery pathwayMultidisciplinary approach alongside the orthopedic surgeon | Other | – |
Primary outcome
Evaluation of the Fast track protocol
Time frame: at baseline (Day0)
Evaluation of an intra- and post-operative fast-track protocol in terms of postoperative pain management.
Evaluation of the Fast track protocol
Time frame: at baseline (Day0)
Evaluation of an intra- and post-operative fast-track protocol in terms of duration/times of hospitalization
Evaluation of the Fast track protocol
Time frame: at baseline (Day0)
Evaluation of an intra- and post-operative fast-track protocol in terms of blood loss
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.
3 secondary outcomes
Surgical and clinical outcome
Time frame: at baseline (Day0)
Surgical and clinical outcome
Time frame: at baseline (Day0)
Surgical and clinical outcome
Time frame: at baseline (Day0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Results publication: PubMed 33098493Wang 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.
- Results publication: PubMed 33094437Lee 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.
- Results publication: PubMed 30214945Seki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the Fast track protocol (time frame: at baseline (Day0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05011734, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.