Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)

NCT07775729 | Not Yet Recruiting

• 1 other identifier: CS-07
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Degenerative Disc Disease; Spinal Stenosis Lumbar; Lumbar Spine Fusion; Spondylolisthesis; Spinal Stenosis, Lumbar Region; Transforaminal Lumbar Interbody Fusion

Keywords

ProteiOS; HCT/P; bone graft; spinal fusion; lumbar interbody fusion; growth factor; allograft; TLIF

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  12 Months

Secondary Outcomes (9)

• Fusion (via Computed Tomography (CT))

  6 and 24 months

• Fusion (x ray)

  3, 6, 12, 24 months

• Adverse Events

  24 months

• Patient Reported Outcome: Visual Analog Scale (VAS)

  3, 6, 24 Months

• Patient Reported Outcome: Neurological

  3, 6, 24 Months

Study Arms (4)

TLIF - ProteiOS (Treatment)

EXPERIMENTAL

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.

Other: Allograft-derived growth factor (ProteiOS®)

TLIF - Control

ACTIVE COMPARATOR

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.

Other: Standard of Care (SOC)

ALIF - ProteiOS (Treatment)

EXPERIMENTAL

Same ProteiOS-based mixture as TLIF treatment arm

Other: Allograft-derived growth factor (ProteiOS®)

ALIF - Control

ACTIVE COMPARATOR

Same control graft composition as TLIF control arm

Other: Standard of Care (SOC)

Interventions

Allograft-derived growth factor (ProteiOS®) OTHER

Allograft-derived growth factor product (ProteiOS®) containing endogenous osteoinductive, angiogenic, and chemoattractant proteins bound to a scaffold of choice

ALIF - ProteiOS (Treatment); TLIF - ProteiOS (Treatment)

Standard of Care (SOC) OTHER

Local autograft with optional mineralized cancellous allograft chip augmentation

ALIF - Control; TLIF - Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isto Biologics: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Spinal Stenosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and investigators/surgeons are not blinded (surgeon must know which graft material to use intraoperatively). The central imaging core laboratory (independent, board-certified musculoskeletal/neuroradiologists performing BSF fusion grading) is blinded to treatment arm, site identity, clinical status, and prior imaging.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 randomization to ProteiOS (treatment) vs. control within each of two surgical cohorts (TLIF, ALIF)

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 20, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share