Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)
18 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Interventionnel
Inscription (Estimé)
280
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Comparateur actif: 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
|
|
Expérimental: 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
|
|
Comparateur actif: ALIF - Control
Same control graft composition as TLIF control arm
|
Local autograft with optional mineralized cancellous allograft chip augmentation
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of Fusion Success (via Computed Tomography (CT) analysis)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fusion (via Computed Tomography (CT))
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: Up to 24 months
|
Number of hospital visits per participant, up to 24 months.
|
Up to 24 months
|
|
Healthcare Utilization: Length of Hospital Stay
Délai: Up to 24 months
|
Duration of hospital stay per participant, in days, up to 24 months.
|
Up to 24 months
|
|
Healthcare Utilization: ICU Time
Délai: Up to 24 Months
|
Duration of ICU stay per participant, in days, up to 24 months.
|
Up to 24 Months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 décembre 2026
Achèvement primaire (Estimé)
1 décembre 2029
Achèvement de l'étude (Estimé)
1 janvier 2030
Dates d'inscription aux études
Première soumission
11 août 2026
Première soumission répondant aux critères de contrôle qualité
18 août 2026
Première publication (Réel)
20 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies osseuses
- Maladies musculo-squelettiques
- Maladies de la colonne vertébrale
- Spondylolyse
- Spondylose
- Sténose spinale
- Spondylolisthésis
- Dégénérescence des disques intervertébraux
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Qualité des soins de santé
- Indicateurs de qualité, soins de santé
- Standard de soins
Autres numéros d'identification d'étude
- CS-07
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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