Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)

N/ANot Yet RecruitingNCT07775729

Isto Biologics280 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of Fusion Success (via Computed Tomography (CT) analysis)

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.

Time frame: 12 months

Patient Reported Outcome: Oswestry Disability Index (ODI)

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.

Time frame: 12 Months

Patient Reported Outcome: Neurological

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).

Time frame: 12 Months

Patient Reported Outcome: Visual Analog Scale (VAS)

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.

Time frame: 12 Months

Secondary Outcomes

Fusion (via Computed Tomography (CT))

Time frame: 6 and 24 months

Fusion (x ray)

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.

Time frame: 3, 6, 12, 24 months

Adverse Events

Nature (descriptive) and frequency (number) of procedure and biologic related Adverse Events and Serious Adverse Events

Time frame: 24 months

Patient Reported Outcome: Visual Analog Scale (VAS)

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.

Time frame: 3, 6, 24 Months

Patient Reported Outcome: Neurological

Time frame: 3, 6, 24 Months

Patient Reported Outcome: Oswestry Disability Index (ODI)

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.

Time frame: 3, 6, 24 Months

Healthcare utilization: Frequency of Hospital Visits

Number of hospital visits per participant, up to 24 months.

Time frame: Up to 24 months

Healthcare Utilization: Length of Hospital Stay

Duration of hospital stay per participant, in days, up to 24 months.

Time frame: Up to 24 months

Healthcare Utilization: ICU Time

Duration of ICU stay per participant, in days, up to 24 months.

Time frame: Up to 24 Months

Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes