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
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.
Exclusion Criteria:
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
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Hospices Civils de Lyon