Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)

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.

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