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Efficacy of Sub-laminar and/or Interspinous Tethers to Prevent Proximal Junctional Kyphosis After Surgical Correction of Adult Spinal Deformity (TRANSITION)

28 de mayo de 2026 actualizado por: Hospices Civils de Lyon

Efficacy of Sub-laminar and/or Interspinous Tethers to Prevent Proximal Junctional Kyphosis After Surgical Correction of Adult Spinal Deformity - Randomized Multicentric Single Blind Controlled Trial

PJK (proximal junctional kyphosis) at the upper end of spinal fusions after surgical correction of adult spinal deformity is not uncommon. Two-thirds of cases are observed within the first 3 months after surgery and 80% within the first 18 months. PJK is consequently a common problem after surgery for adult spinal deformity, representing one of the most frequent complications following this kind of procedure. Although the first-line treatment of this event is conservative, surgery may be necessary in around 30-40% of cases. Revision surgery generally consists of extending the posterior spinal instrumentation.

Prophylactic vertebroplasty has been proposed to reduce the risk of PJK and PJF, with promising results but with the limitation of reinforcing only the bony structures, with no action on the soft tissues. In this context, some authors have reported that the use of tethers, creating a transitional zone at the upper end of the construct between the fused and the non-instrumented spine, could reduce the occurrence of this complication (PJK). One of the hypotheses is that the use of a topping-off system results in a transitional zone reducing stresses at the junctional spine and may reduce the occurrence of both PJK and the need for reoperation.

Compared with other topping-off systems, such as hooks, the surface of contact provided by the bands on the posterior arches is much greater and the primary stability much better. In addition, the risk of malposition is extremely low.

The aim of this study is therefore to compare the occurrence of PJK and PJF in patients for whom tethers were implanted at the upper end of the instrumentation versus patients for whom no tether system was used.

In a retrospective study conducted in the neurosurgery department of the HCL on 38 patients undergoing multilevel spine instrumentation with junctional tethers, PJK occurred in 8 of them (21%) after 24 months of follow-up.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

128

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Francia
      • Lyon, Francia, 69394
        • Hôpital Pierre Wertheimer - Hospices Civils de Lyon, Service de Neurochirurgie - Chirurgie du Rachis et de la Moëlle Epinière
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Cédric BARREY, Ph

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Patient men and women older than 18
  • Patient indicated spinal posterior fusion and instrumentation with the upper end (UIV with screws) between T9 and L2 and the lower end between L5 and iliac
  • Constructs ≥4 levels (i.e., ≥4 discs included)
  • Patient able to signed a consent form
  • Patient able to fill a self-administered questionnaire
  • Patient affiliated to health care insurance (social security in France

Exclusion Criteria:

  • Allergy to metal
  • Cimentoplasty at the junctional zone (UIV, UIV+1 and/or UIV+2)
  • Bone metabolism disorders that potentially compromise the mechanical support expected from this type of implant.
  • Morbid obesity (BMI > 40)
  • Patients with infection (in particularly osteomyelitis)
  • Cancer of lesss than 5 years or currently treated
  • Acute trauma
  • Immunodepression
  • Parkinson
  • Chronic inflammatory disease
  • Severe psychological disorders
  • Pregnancy or women breastfeeding
  • Inadequate tissue coverage of implant site,
  • Interference with other critical anatomical structures.
  • Patient not being able to understand the objectives of the study or refusing to comply with postoperative instructions
  • Patient participating in an ongoing study that may interfere with this study
  • Patient under legal protection

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Patient instrumented with a tether
Sub-laminar and/or interspinous tethers
Dispositivo: Tether strategy
During spine surgery sub-laminar or interspinous bands are utilized in combination with standard posterior rigid instrumentation (i.e. screws and metallic rods). They are typically implanted at the upper vertebral level, above the cranial screws, and then connected to the rods. Their implantation is based on standard surgical techniques for spine surgeons.
Comparador activo: Reference strategy
Standard surgery
Procedimiento: Reference
Patient will undergo the spine surgery as the standard of care, using only standard posterior rigid instrumentation (i.e. screws and metallic rods).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sub-laminar and/or interspinous tethers efficacy to prevent PJK
Periodo de tiempo: From enrollment to 24 months post-surgery

Percentage of patients with PJK during the first post-operative 24 months with PJK defined as :

  • a proximal junctional sagittal Cobb angle (PJA) between the lower endplate of uppermost instrumented vertebra (UIV) with screws and the upper endplate of 2 supra-adjacent vertebra ≥15
  • a 15° delta between 24months post operative PJA and preoperative PJA These 2 parameters will be assessed by an independent committee using radiographic images preop and 24 months postop
From enrollment to 24 months post-surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sub-laminar and/or interspinous tethers efficacy to prevent PJF
Periodo de tiempo: From enrollment to 24 months post-surgery
Comparison between the 2 randomized groups with or without tethers at 24 months: Percentage of patients with PJF, defined as a progressive process in the spectrum of PJK with structural failures such as vertebral body fracture and/or posterior ligament complex, and vertebral subluxation
From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent surgery revision
Periodo de tiempo: From enrollment to 24 months post-surgery
Percentage of patients with an indication of revision surgery
From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent the level of disabilty
Periodo de tiempo: From enrollment to 24 months post-surgery
Disability assed with Oswestry Disability Index questionnaire. It is composed of questions on the following items : pain intensity, personal care (washing, dressing), lifting objects, moving around, sitting or standing, sleeping, sex life, social life, and travel/transportation. Each items is scored from 0 to 5, 0 being absence of disability and 5 the most severe disability. The final score range from 0 to 50 and there is 6 level of disability according to final score categories: 0-4 no disability, 5-14 light disability, 15-24 moderate disability, 25-34 severe disability and 35-50 complete disability.
From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent pain
Periodo de tiempo: From enrollment to 24 months post-surgery
Evolution of radicular and lumbar Pain assessed with a Visual Analogic Scale rated from 0 to 10, 0 being the absence of pain and 10 the worst pain ever experienced.
From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to enhance quality of life
Periodo de tiempo: From enrollment to 24 months post-surgery
Evolution of the mean Quality-of-Life score will be assessed using the EQ-5D-5L questionnaire. The EQ-5D-5L, developed by the EuroQol Group to improve sensitivity and reduce ceiling effects, includes two components: the descriptive system and the visual analogue scale (EQ VAS). The descriptive system covers five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each rated on five levels from no problems to extreme problems, generating a 5-digit health state code. The EQ VAS records the patient's self-rated health on a vertical scale ranging from the best to the worst imaginable health, providing a quantitative measure based on the patient's own judgement.
From enrollment to 24 months post-surgery
Sub-laminar and/or interspinous tethers efficacy to prevent post-operative complications
Periodo de tiempo: From enrollment to 24 months post-surgery
The number of peri- and post-operative complications including mechanical complication due to the device, infections, neurological and general complications.
From enrollment to 24 months post-surgery
Assess the efficiency of implanting tethers at the upper part of the construct in patient with an indication for spinal posterior fusion performing cost-utility and cost-effectiveness analyses
Periodo de tiempo: From enrollment to 24 months post-surgery
Incremental cost-utility and cost-effectiveness ratios of implanting tethers at the upper part of the construct (tethers group) compare to the standard procedure without tethers at 24 months post-surgery.
From enrollment to 24 months post-surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hospices Civils de Lyon

Investigadores

  • Investigador principal: Cédric BARREY, Ph, Hospices Civiles de Lyon

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

22 de junio de 2026

Finalización primaria (Estimado)

22 de junio de 2030

Finalización del estudio (Estimado)

22 de junio de 2030

Fechas de registro del estudio

Enviado por primera vez

13 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de mayo de 2026

Publicado por primera vez (Actual)

1 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 69HCL24_0720
  • 2026-A00732-49 (Otro identificador: ID-RCB)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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