Clinical trial NCT06908213: Multicentric Evaluation of Enhanced Recovery After Surgery Protocol in Adolescent Idiopathic Scoliosis Surgery
Official title: Multicentric Evaluation of Enhanced Recovery After Surgery Protocol in Adolescent Idiopathic Scoliosis Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Idiopathic Scoliosis
Keywords: Idiopathic scoliosis
adolescents
Enhanced recovery after surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 316
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, RIPH2
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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:

* 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Demonstrate that ERAS in adolescent idiopathic scoliosis compared to standard of care procedure
timeFrame: At Month 3 (Collected on the day of discharge from surgery hospitalization)
Secondary outcomes:
measure: Improvement of quality of life at one day after return at home
timeFrame: Day 1 (VT1) after discharge from surgery hospitalization
measure: Improvement of quality of life at 5 days, 45 days and 12 months after return at home
timeFrame: Day 1 (VT1), day 45 (V4) and month 12 (V5) after discharge from surgery hospitalization
measure: Changing post-surgical pain during hospitalization
timeFrame: Day 0 (V3), day 1 (VT1), day 5 (VT3); day 45 (V4) and month 12 (V5) after discharge from surgery hospitalization]
measure: Changing post-surgical pain at day 1, day 5, day 45 and month 12 after return at home
timeFrame: Day 1 (VT1), day 5 (VT1), day 45 (V4) and month 12 (V5) after discharge from surgery hospitalization
measure: Changing post-surgical complications at day 45 and month 12
timeFrame: Day 45 (V4) and month 12 (V5)
measure: Changing the rate of re-hospitalization during the 12 months following surgery
timeFrame: From day of surgery day 0 (V3) to month 12 (V5)
measure: Describe the acceptability of the early discharge date from hospitalization in the two arms by patients and their parents
timeFrame: Day of surgery day 0 (V3)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens Site Sud
city: Besançon
country: France
facility: CHU de Besançon Hopital Jean Minjoz
city: Bron
country: France
facility: Pediatric orthopedic surgery unit Hôpital femme Mère Enfant (HFME)
city: La Tronche
country: France
facility: CHU de Grenoble Hôpital Couple Enfant
city: Lyon
country: France
facility: Centre Medico-Chirurgical de Réadaptation des Massues Croix-Rouge
city: Marseille
country: France
facility: AP-HM Hôpital de la Timone
city: Nice
country: France
facility: Fondation LENVAL
city: Saint-priest-en-jarez
country: France
facility: CHU de Saint-Etienne Hôpital Nord
city: Toulouse
country: France
facility: CHU de Toulouse
city: Toulouse
country: France
facility: Clinique Médipôle Garonne
city: Trelaze
country: France
facility: Clinique St Leonard
Study officials:
References: