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Idiopathic ScoliosisEMRACSIANCT06908213

Multicentric Evaluation of Enhanced Recovery After Surgery Protocol in Adolescent Idiopathic Scoliosis Surgery

A study testing Posterior vertebral fusion surgery with Enhanced Recovery After Surgery (ERAS) procedure in people with Idiopathic Scoliosis, run by Hospices Civils de Lyon at 11 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Adolescent idiopathic scoliosis is a deformation of the spine affecting 2 to 4% of under 18 years old population. This can have severe physical or psychological impact during adulthood. The deformation causes mechanical constraints resulting in early osteoarthritis, which results in adulthood disability. Read more about this study

Who is it for?
Ages 11 to 17 years
Conditions the study is for
Idiopathic Scoliosis
What is being tested?
Posterior vertebral fusion surgery with Enhanced Recovery After Surgery (ERAS) procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
11 sitesFrance
Study dates
21 Sep 2026to 21 Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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 11 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Adolescents between 11 and 17 years old
  • Adolescent idiopathic scoliosis diagnosis
  • Posterior vertebral fusion surgery indicated to treat the patient
  • Informed consent signed by both parents / legal guardians

Who cannot join

  • Comorbidities that might influence the duration of hospitalization (e.g. respiratory failure, diabetes…)
  • Previous spine surgery
  • Patient not benefiting from an health insurance plan
  • Pregnant, parturient or breastfeeding woman
  • Patient benefiting of psychiatric care
  • Patient subject to a legal protection measure (guardianship, curatorship)

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

11 sites in 1 country

France11 sites, 11 recruiting
  • CHU d'Amiens Site Sud

    Amiens, 80054

    Richard GOURON, MD, 03 22 08 75 50 ext. +33, Gouron.Richard@chu-amiens.fr

    Richard GOURON, MD

    Recruiting
  • CHU de Besançon Hopital Jean Minjoz

    Besançon, 25000

    Jeremie NALLET, MD, 03 81 21 94 01 ext. +33, jnallet@chu-besancon.fr

    Jeremie NALLET, MD

    Recruiting
  • Pediatric orthopedic surgery unit Hôpital femme Mère Enfant (HFME)

    Bron, 69677

    Vincent CUNIN, MD, 04 27 85 51 32 ext. +33, vincent.cunin@chu-lyon.fr

    Vincent CUNIN, MD

    Recruiting
  • CHU de Grenoble Hôpital Couple Enfant

    La Tronche, 38700

    Aurélien COURVOISIER, MD, 04 76 76 59 00 ext. +33, aurelien.courvoisier@gmail.com

    Aurélien COURVOISIER, MD

    Recruiting
  • Centre Medico-Chirurgical de Réadaptation des Massues Croix-Rouge

    Lyon, 69322

    Kariman ABELIN-GENEVOIS, MD, 04 72 38 48 58 ext. +33, Kariman.abelin-genevois@croix-rouge.fr

    Kariman ABELIN-GENEVOIS, MD

    Recruiting
  • AP-HM Hôpital de la Timone

    Marseille, 13005

    Sebastien PESENTI, MD, 04 91 38 86 56 ext. +33, Seb.pesenti@gmail.com

    Sebastien PESENTI, MD

    Recruiting
  • Fondation LENVAL

    Nice, 06200

    Frederico SOLLA, MD, 04 92 03 04 91 ext. +33, SOLLA.F@pediatrie-chulenval-nice.fr

    Frederico SOLLA, MD

    Recruiting
  • CHU de Saint-Etienne Hôpital Nord

    Saint-Priest-en-Jarez, 42270

    Elie HADDAD, MD, 04 77 82 80 37 ext. +33, Elie.haddad@chu-st-etienne.fr

    Elie HADDAD, MD

    Recruiting
  • CHU de Toulouse

    Toulouse, 31059

    Tristan LANGLAIS, MD, 05 34 55 85 24 ext. +33, Langlais.t@chu-toulouse.fr

    Tristan LANGLAIS, MD

    Recruiting
  • Clinique Médipôle Garonne

    Toulouse, 31100

    Roxane COMPAGNON, MD, 05 62 13 28 52 ext. +33, roxane.compagnon@gmail.com

    Roxane COMPAGNON, MD

    Recruiting
  • Clinique St Leonard

    Trélazé, 49800

    Audrey ANGELLIAUME, MD, 02 41 41 73 73 ext. +33, dr.audrey.angelliaume@gmail.com

    Audrey ANGELLIAUME, MD

    Recruiting

Other trials in France

About this study

Adolescent idiopathic scoliosis is a deformation of the spine affecting 2 to 4% of under 18 years old population. This can have severe physical or psychological impact during adulthood. The deformation causes mechanical constraints resulting in early osteoarthritis, which results in adulthood disability.

There is also an impact on the respiratory function in most severe cases of idiopathic scoliosis. Adolescents affected by a scoliosis with an angle of 40° of more undergo a surgery called posterior fusion during adolescence to limit these impacts.

Read more

In France, more than 1000 adolescent patients undergo a surgery called posterior spinal fusion for their severe scoliosis.

This aims to straighten the spine by bone grafting all the vertebras included in the scoliosis. Two metal rods are implanted to favour osteosynthesis of the straight spine.

This intervention suffer of a bad image and worries the patients and their parents, as it needs metal implants near the spinal cord.

The worry comes from the most severe complication that may happen exceptionally following this surgery, which is a definitive paraplegia. The scar is quite large and the surgery reduces the mobility of a part of the spine. The intervention produces a quite large haemorrhage, which leads to a diminution in haemoglobin level, resulting in a fatigue during the following weeks.

On the following days, the patient will need a specific protocol of pain management including morphine-based and anti-inflammatory drugs.

This intervention will often require a 5 to 7 days hospitalization with a 1 to 2 month convalescence period at home or in rehabilitation centre.

This intervention is performed on adolescent patients without comorbidities. Moreover, the surgical approach is not profound passing between the para-vertebral muscles with no close large blood vessels or major organs. The pain is caused by correction tensions and the access to the vertebras during the surgery.

Surgical techniques have considerably evolved allowing shorter interventions and to reduce the loss of blood.

The association between morphine-based treatments and grade I analgesics enables an effective pain management.

This intervention appears to perfectly suit to an enhanced recovery after surgery procedure (ERAS).

ERAS is a set of procedure meant to enhance its tolerance and to reduce its morbidity and the hospitalization duration after surgery and the recovery duration.

ERAS is well developed in adult patients undergoing surgery, it is also well described in paediatric patient especially on adolescent scoliosis surgeries.

As the pain is well controlled during the hospitalization as well when the patient get back home, there are very few obstacles to an ERAS procedure in this indication for a patient without comorbidities.

Numerous articles report experiences of medical staff with ERAS protocols.

Generally, the set of measures includes:

  • Before surgery: Providing information and therapeutic patient education, iron supplementation, physiotherapy, skin disinfection, digestive preparation against constipation
  • During surgery: recuperations of blood cells to limit blood loss, use of modern tools to facilitate the positioning of pedicle screws, surgery performed by 2 surgeons
  • After surgery: Pain management until stopping of analgesics by patient and maintenance of a link between the patient at home and the hospital staff after end of hospitalization The articles published about ERAS reports a favourable experience of such protocols with an efficient pain management, reduced hospitalization durations without increasing morbidity or re-hospitalizations. However, no studies have studied and proved by a robust scientific method the benefits of ERAS in adolescent scoliosis.

No studies evaluate the patients' quality of life or follow the patient for more than 6 months after surgery (limiting the assessment of long term complications e.g. infectious complications).

The link between hospital staff and the patient after his return back home is not described as well.

This research project aims to confirm with a robust scientific approach that ERAS protocols in idiopathic scoliosis in adolescents allow to reduce the duration of hospitalization compared to standard of care procedures while improving quality of life after surgery.

Being tested
Posterior vertebral fusion surgery with Enhanced Recovery After Surgery (ERAS) procedure, Posterior vertebral fusion surgery with standard of care procedure
Keywords
Idiopathic scoliosis, adolescents, Enhanced recovery after surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Posterior vertebral fusion surgery with Enhanced Recovery After Surgery (ERAS) procedureProcedure or surgery

    This will include at least:

    • A one-day hospitalization to visit the surgical unit and to provide therapeutic education to patients and their parents.
    • A transition to morphine based treatments per os from intravenous morphine on the second day following surgery
    • Phone calls from a surgery unit nurse 2 times a day during 5 days
    • A teleconsultation with the surgeon between D3 and D5 following surgery
  • Posterior vertebral fusion surgery with standard of care procedureProcedure or surgery

    Patients in this group will undergo posterior vertebral fusion surgery without the set of procedures for ERAS.

    They will have a first consultation with the anesthesist and the surgeon then the surgery will be planned. The discharge from hospital after surgery will not happen early and the standard of care procedures will be followed during and after surgery.

    Patients will receive 2 phone calls at D1 and D5 after surgery. The patient will also have 2 appointments at the hospital for post-surgical follow-up at D45 and M12.

Study groups in NCT06908213
Study groupRoleWhat they receive
Experimental group : Improved Recovery After SurgeryExperimentalPatients in this group will undergo vertebral posterior fusion surgery with the Enhanced recovery after surgery protocol. This will include at least: * A one-day hospitalization to visit the surgical unit and to provide therapeutic education to patients and their parents. * A transition to morphine based treatments per os from intravenous morphine on the second day following surgery * Phone calls from a surgery unit nurse 2 times a day during 5 days * A teleconsultation with the surgeon between D3 and D5 following surgery Patients will also have a first consultation with the anesthesist and the surgeon then the surgery will be planned. They will also have 2 appointments at the hospital for post-surgical follow-up at D45 and M12.
Receives: Procedure: Posterior vertebral fusion surgery with Enhanced Recovery After Surgery (ERAS) procedure
Control groupExperimentalPatients in this group will undergo posterior vertebral fusion surgery without the set of procedures for ERAS. They will have a first consultation with the anesthesist and the surgeon then the surgery will be planned. The discharge from hospital after surgery will not happen early and the standard of care procedures will be followed during and after surgery. Patients will receive 2 phone calls at D1 and D5 after surgery. The patient will also have 2 appointments at the hospital for post-surgical follow-up at D45 and M12.
Receives: Procedure: Posterior vertebral fusion surgery with standard of care procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demonstrate that ERAS in adolescent idiopathic scoliosis compared to standard of care procedure

    Hospitalization duration measured in days

    Measured: At Month 3 (Collected on the day of discharge from surgery hospitalization)

Secondary outcomes (7)
  1. Improvement of quality of life at one day after return at home

    Quality of life questionnaires (PedsQL) at day 1 after return at home 4-point scale : 0 if it's never a problem

    1. if it's almost never a problem
    2. if it's sometimes a problem
    3. if it's often a problem
    4. if it's almost always a problem

    Measured: Day 1 (VT1) after discharge from surgery hospitalization

  2. Improvement of quality of life at 5 days, 45 days and 12 months after return at home

    Quality of life questionnaires (PedsQL) at day 5, day 45 and month 12 after return at home 4-point scale : 0 if it's never a problem

    1. if it's almost never a problem
    2. if it's sometimes a problem
    3. if it's often a problem
    4. if it's almost always a problem

    Measured: Day 1 (VT1), day 45 (V4) and month 12 (V5) after discharge from surgery hospitalization

  3. Changing post-surgical pain during hospitalization

    Visual analog pain scale during surgery hospitalization 10-point scale: 0: no pain 10: uncontrollable pain

    Measured: Day 0 (V3), day 1 (VT1), day 5 (VT3); day 45 (V4) and month 12 (V5) after discharge from surgery hospitalization]

  4. Changing post-surgical pain at day 1, day 5, day 45 and month 12 after return at home

    Visual analog pain scale 10-point scale: 0: no pain 10: uncontrollable pain

    Measured: Day 1 (VT1), day 5 (VT1), day 45 (V4) and month 12 (V5) after discharge from surgery hospitalization

  5. Changing post-surgical complications at day 45 and month 12

    Complications after surgery at day 45 and month 12 10-point scale: 0: no pain 10: uncontrollable pain

    Measured: Day 45 (V4) and month 12 (V5)

  6. Changing the rate of re-hospitalization during the 12 months following surgery

    Re-hospitalization rate during the 12 monts following surgery

    Measured: From day of surgery day 0 (V3) to month 12 (V5)

  7. Describe the acceptability of the early discharge date from hospitalization in the two arms by patients and their parents

    Percentage of parents refusal for early discharge date

    Measured: Day of surgery day 0 (V3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2025
  2. Study start21 Sep 2026
  3. Primary completion21 Aug 2030 (estimated)
  4. Study completion21 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, multicenter, RIPH2
Masking
None (open label)
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06908213
Sponsor's protocol ID
69HCL23_0742
Acronym
EMRACSIA
Status last verified
Sep 2026
First submitted
7 Mar 2025
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Posterior vertebral fusion surgery with Enhanced Recovery After Surgery (ERAS) procedure in people with Idiopathic Scoliosis, run by Hospices Civils de Lyon at 11 sites in France.

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 4 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vincent CUNIN (04 27 85 51 32 ext. +33, vincent.cunin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demonstrate that ERAS in adolescent idiopathic scoliosis compared to standard of care procedure (time frame: At Month 3 (Collected on the day of discharge from surgery hospitalization)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 24 Sep 2026.

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