Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)
18 de agosto de 2026 actualizado por: Isto Biologics
Prospective, Multicenter Evaluation of ProteiOS® Allograft Derived Growth Factor in Transforaminal Lumbar Interbody Fusion (TLIF)
This is a prospective, multicenter, randomized, controlled study evaluating Influx™ ProteiOS®, an allograft-derived growth factor product, in transforaminal lumbar interbody fusion (TLIF).
Participants undergoing 1- to 2-level TLIF (L2-S1) are randomized 2:1 to receive ProteiOS or a control graft (local bone with optional cancellous chip augmentation, no ProteiOS).
The primary objective is to determine whether the 12-month interbody fusion rate (assessed by CT using the Brantigan-Steffee-Fraser classification) with ProteiOS is non-inferior to control, using a 5-percentage-point non-inferiority margin.
Patient-reported outcomes (ODI, VAS, EQ-5D-5L), safety, and healthcare utilization are also assessed.
A separate exploratory cohort at one study site will evaluate the same outcomes in participants undergoing anterior lumbar interbody fusion (ALIF) with or without ProteiOS, without formal hypothesis testing.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Transforaminal lumbar interbody fusion (TLIF) is a widely used technique for degenerative lumbar spine pathology.
Prospective, randomized evidence on fusion outcomes, patient-reported outcomes, safety, and healthcare utilization for ProteiOS in TLIF is currently limited to retrospective data.
This study randomizes participants 2:1 to ProteiOS versus a within-category control (standard graft material, no ProteiOS), with central, blinded, independent radiographic review of CT and X-ray fusion outcomes.
The primary endpoint is CT-confirmed interbody fusion (BSF-3) at 12 months, tested for non-inferiority (margin = 5 percentage points, assumed fusion rates 95% ProteiOS vs. 89% control, 80% power, one-sided α = 0.025, Farrington-Manning likelihood score method).
Secondary endpoints include fusion at 6 and 24 months, X-ray-based interbody and posterolateral fusion assessment (Lenke classification for PLF), patient-reported outcomes at 3, 6, and 24 months, adverse events, and healthcare utilization
Tipo de estudio
Intervencionista
Inscripción (Estimado)
280
Fase
- No aplica
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
- Age 18-75 years, skeletally mature at time of surgery
- Degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented TLIF, with or without posterolateral fusion, as determined by the treating surgeon
- For the ALIF study site only: degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented ALIF
- Radiographic evidence of degenerative lumbar disease on CT, MRI, or plain radiograph (decreased disc height, herniated nucleus pulposus, ligamentum flavum/annulus hypertrophy, facet arthrosis/osteophyte, spinal canal or foraminal stenosis, or vertebral translation >3 mm)
- Symptoms of low back pain, radiculopathy, or neurogenic claudication consistent with radiographic findings
- Preoperative back pain ≥4 on a 0-10 VAS
- Preoperative leg pain ≥3 on a 0-10 VAS, consistent with radiculopathy or neurogenic claudication
- Preoperative ODI score ≥30
- Failure of ≥6 months non-operative treatment (may be waived for progressive neurological deficit, new/worsening motor weakness, bowel/bladder dysfunction, or cauda equina syndrome)
- Willing and able to comply with follow-up schedule and provide written informed consent
Exclusion Criteria:
- Scheduled for surgery with synthetic bone grafts containing hydroxyapatite, tricalcium phosphate, or other radio-opaque material
- BMI >40
- Prior lumbar spine fusion surgery at a level currently scheduled for surgery
- Malignancy or treatment for malignancy within the last 5 years (benign skin cancer permitted)
- Osteoporosis/osteopenia (≤2.5 SD below age-matched mean)
- Use of rhBMP-2 (Infuse) or other active biologics
- Active or systemic infection, malignancy, or severe metabolic bone disease
- Chronic steroid use (>10 days)
- Revision fusion at index levels
- Participation in another interventional clinical study within 30 days of consent
- Known pregnancy or intent to become pregnant during the study
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: TLIF - ProteiOS (Treatment)
Influx™ demineralized cortical fibers combined 1:1 with ProteiOS®, ≥50% of total graft volume per level (5-15 cc total), optional cancellous allograft chip augmentation.
If PLF indicated: 100% cortical fiber graft + ProteiOS + local bone in Fibrant PAK containment bag.
|
Allograft-derived growth factor product (ProteiOS®) containing endogenous osteoinductive, angiogenic, and chemoattractant proteins bound to a scaffold of choice
|
|
Comparador activo: TLIF - Control
5-15 cc locally harvested autograft, optional mineralized cancellous allograft chip augmentation, no ProteiOS.
If PLF indicated: cortical fiber graft + local bone in Fibrant PAK containment bag.
|
Local autograft with optional mineralized cancellous allograft chip augmentation
|
|
Experimental: ALIF - ProteiOS (Treatment)
Same ProteiOS-based mixture as TLIF treatment arm
|
Allograft-derived growth factor product (ProteiOS®) containing endogenous osteoinductive, angiogenic, and chemoattractant proteins bound to a scaffold of choice
|
|
Comparador activo: ALIF - Control
Same control graft composition as TLIF control arm
|
Local autograft with optional mineralized cancellous allograft chip augmentation
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of Fusion Success (via Computed Tomography (CT) analysis)
Periodo de tiempo: 12 months
|
Percentage of participants achieving fusion success, defined as Brantigan-Steffee-Fraser (BSF) classification Grade 3 (solid fusion: trabecular bone bridging across ≥50% of the interbody fusion area) at the treated level(s), assessed by CT scan.
BSF is a 3-grade classification ranging from Grade 1 (pseudarthrosis) to Grade 3 (solid fusion), with higher grade indicating better fusion status.
|
12 months
|
|
Patient Reported Outcome: Oswestry Disability Index (ODI)
Periodo de tiempo: 12 Months
|
Oswestry Disability Index (ODI), a 10-item questionnaire assessing functional disability due to low back pain (raw score converted to a percentage, range 0-100%; 0 = no disability, 100 = maximum disability; higher score = worse disability), assessed at 12 months; mean scores compared between treatment and control arms.
|
12 Months
|
|
Patient Reported Outcome: Neurological
Periodo de tiempo: 12 Months
|
Neurological status: Percentage of participants with no new or worsening neurological deficit from baseline, assessed across three components: motor function (Medical Research Council [MRC] grading scale, range 0-5, higher score indicates greater strength), sensory function (graded as intact, diminished, or absent), and deep tendon reflexes (graded as absent, diminished, normal, or hyperreflexic).
|
12 Months
|
|
Patient Reported Outcome: Visual Analog Scale (VAS)
Periodo de tiempo: 12 Months
|
Visual Analog Scale (VAS) for leg and back pain (range 0-10; 0 = no pain, 10 = worst pain imaginable; higher score = worse pain), assessed at 12 months; mean scores compared between treatment and control arms.
|
12 Months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fusion (via Computed Tomography (CT))
Periodo de tiempo: 6 and 24 months
|
Percentage of participants achieving fusion success, defined as Brantigan-Steffee-Fraser (BSF) classification Grade 3 (solid fusion: trabecular bone bridging across ≥50% of the interbody fusion area) at the treated level(s), assessed by CT scan.
BSF is a 3-grade classification ranging from Grade 1 (pseudarthrosis) to Grade 3 (solid fusion), with higher grade indicating better fusion status.
|
6 and 24 months
|
|
Fusion (x ray)
Periodo de tiempo: 3, 6, 12, 24 months
|
Percentage of participants achieving fusion by X-ray.
Interbody fusion (all participants): Brantigan-Steffee-Fraser (BSF) classification, Grade 1 (pseudarthrosis) to Grade 3 (solid fusion); success = Grade 3; higher grade = better.
|
3, 6, 12, 24 months
|
|
Adverse Events
Periodo de tiempo: 24 months
|
Nature (descriptive) and frequency (number) of procedure and biologic related Adverse Events and Serious Adverse Events
|
24 months
|
|
Patient Reported Outcome: Visual Analog Scale (VAS)
Periodo de tiempo: 3, 6, 24 Months
|
Visual Analog Scale (VAS) for leg and back pain (range 0-10; 0 = no pain, 10 = worst pain imaginable; higher score = worse pain); mean scores compared between treatment and control arms.
|
3, 6, 24 Months
|
|
Patient Reported Outcome: Neurological
Periodo de tiempo: 3, 6, 24 Months
|
Neurological status: Percentage of participants with no new or worsening neurological deficit from baseline, assessed across three components: motor function (Medical Research Council [MRC] grading scale, range 0-5, higher score indicates greater strength), sensory function (graded as intact, diminished, or absent), and deep tendon reflexes (graded as absent, diminished, normal, or hyperreflexic).
|
3, 6, 24 Months
|
|
Patient Reported Outcome: Oswestry Disability Index (ODI)
Periodo de tiempo: 3, 6, 24 Months
|
Oswestry Disability Index (ODI), a 10-item questionnaire assessing functional disability due to low back pain (raw score converted to a percentage, range 0-100%; 0 = no disability, 100 = maximum disability; higher score = worse disability); mean scores compared between treatment and control arms.
|
3, 6, 24 Months
|
|
Healthcare utilization: Frequency of Hospital Visits
Periodo de tiempo: Up to 24 months
|
Number of hospital visits per participant, up to 24 months.
|
Up to 24 months
|
|
Healthcare Utilization: Length of Hospital Stay
Periodo de tiempo: Up to 24 months
|
Duration of hospital stay per participant, in days, up to 24 months.
|
Up to 24 months
|
|
Healthcare Utilization: ICU Time
Periodo de tiempo: Up to 24 Months
|
Duration of ICU stay per participant, in days, up to 24 months.
|
Up to 24 Months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
1 de diciembre de 2026
Finalización primaria (Estimado)
1 de diciembre de 2029
Finalización del estudio (Estimado)
1 de enero de 2030
Fechas de registro del estudio
Enviado por primera vez
11 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de agosto de 2026
Publicado por primera vez (Actual)
20 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Enfermedades de la columna
- Espondilólisis
- Espondilosis
- Estenosis espinal
- Espondilolistesis
- Degeneración del disco intervertebral
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- CS-07
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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