An interventional study of Posterior vertebral fusion surgery with Enhanced Recovery After Surgery (ERAS) procedure and Posterior vertebral fusion surgery with standard of care procedure in Idiopathic Scoliosis, sponsored by Hospices Civils de Lyon. Recruiting at 11 sites in France. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Supportive care
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Among 57 studies in Scoliosis with a site in France — 18 open to participants now, 20 under way, 1 of them phase 3. Scoliosis · France.
Among the 57 studies in Scoliosis with a site in France, this one is the 2nd largest by planned enrollment of the 25 interventional ones that give a count, is one of 7 that started in 2026, is one of 24 with no phase, reaches primary completion later than 18 of the 19 other live ones, and was the 48th registered.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
Browse Scoliosis studies →18 of the 57 studies in Scoliosis with a site in France are open now. Recruiting first, the newest first:
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française · Sites in France
Ages 11–18 · Healthy volunteers
University Hospital, Limoges · Sites in France
Ages 8–16
EUROS · Sites in France
Ages 5–17
Centre Hospitalier Universitaire, Amiens · Sites in France
Ages 5+
Clinique Bizet · Sites in France
Ages 18+ · Healthy volunteers
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 117 Scoliosis studies recruiting now, 23 (20%) set no upper age limit and 88 (75%) stop at 75 or younger; 98 take children under 18; 14 take healthy volunteers.
This study: 11 Years to 17 Years · all sexes · no healthy volunteers.
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57 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 7 started in 2026.
This study's planned enrollment of 316 is above the median of 45 across 386 interventional studies indexed under Scoliosis.
Median enrollment 60 across the 25 interventional studies, 84 across the 32 observational. Of the 28 that completed or were terminated, 0 (0%) have results posted.
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4 of 57 have an industry lead sponsor. The 10 most frequent:
Hospices Civils de Lyon is the lead sponsor of 1,867 studies on the registry; 448 are open to participants now.
Hospices Civils de Lyon has 2 studies filed under Scoliosis — fewer than ten, so there is no comparison to draw.
3 of the studies in Scoliosis with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07135765Assistance Publique - Hôpitaux de ParisParavertebral Muscles Assessment Using High-resolution MRI in Idiopathic or Neuromuscular Scoliosis Children | 2027-08 |
| NCT07356999Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge FrançaiseCharacterization of Visual Perception Impairments in Patients With Idiopathic Scoliosis | 2027-09-01 |
| NCT07421752Centre Hospitalier Universitaire, AmiensEvaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery | 2027-11 |
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Among the 57 studies in Scoliosis with a site in France, from their registry updates:
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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.
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:
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients 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.
Procedure: Posterior vertebral fusion surgery with Enhanced Recovery After Surgery (ERAS) procedure
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.
Procedure: Posterior vertebral fusion surgery with standard of care procedure
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 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.
Demonstrate that ERAS in adolescent idiopathic scoliosis compared to standard of care procedure
Hospitalization duration measured in days
Time frame: At Month 3 (Collected on the day of discharge from surgery hospitalization)
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
Time frame: Day 1 (VT1) after discharge from surgery hospitalization
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
Time frame: Day 1 (VT1), day 45 (V4) and month 12 (V5) after discharge from surgery hospitalization
Changing post-surgical pain during hospitalization
Visual analog pain scale during surgery hospitalization 10-point scale: 0: no pain 10: uncontrollable pain
Time frame: Day 0 (V3), day 1 (VT1), day 5 (VT3); day 45 (V4) and month 12 (V5) after discharge from surgery hospitalization]
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
Time frame: Day 1 (VT1), day 5 (VT1), day 45 (V4) and month 12 (V5) after discharge from surgery hospitalization
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
Time frame: Day 45 (V4) and month 12 (V5)
Changing the rate of re-hospitalization during the 12 months following surgery
Re-hospitalization rate during the 12 monts following surgery
Time frame: From day of surgery day 0 (V3) to month 12 (V5)
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
Time frame: Day of surgery day 0 (V3)
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Aug 2030, 47 months after the start.
Of 223 non-industry interventional studies with no phase under Scoliosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 58. This study's planned 47 months is above that.
Counting every sponsor, half of 233 studies reached it within 22 months; a quarter within 8 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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