CLINICAL EVIDENCE
Summary Overview
Validated performance in spinal fusion cases
TriForm™ has been evaluated in multiple independent clinical series and preclinical studies. Across both lumbar and cervical fusion procedures, TriForm™ has consistently demonstrated high fusion rates, excellent handling, and predictable remodeling into natural bone without complications. Preclinical data further confirm TriForm’s ability to stimulate bone formation through osteoblast activation and collagen-rich matrix development.
2023 Posterolateral Lumbar Fusion Case Series
Introduction
Amid rising rates of degenerative lumbar disease, Dr. Stephen Robbins, MD, conducted a prospective case series evaluating TriForm™ in Posterolateral Lumbar Fusion (PLF) procedures. The study sought to measure fusion success, safety, and new bone formation when TriForm™ was combined with autograft and bone marrow aspirate.
Methods
Thirteen patients (average age 64) diagnosed with lumbar spondylosis or degenerative disc disease were enrolled. Each underwent PLF using a standard posterior approach with transpedicular screw fixation. TriForm™ was hydrated, mixed with autograft and bone marrow aspirate, and placed into the fusion site. Placement was confirmed fluoroscopically. Radiographic follow-ups were obtained at 6 weeks, 6 months, and 12 months.
Results
• 100% fusion rate achieved at 12 months
• New bone formation observed between 5–12 months
• No complications or adverse events reported
• Radiographs demonstrated progressive bone consolidation:
– 6 weeks: Early callus formation
– 6 months: Robust bridging bone visible
– 12 months: Complete arthrodesis confirmed
Conclusion
This study confirmed TriForm™ as a safe, reliable, and effective graft option for PLF procedures. The 100% fusion success underscores TriForm’s ability to deliver predictable outcomes in complex lumbar fusion cases.
2020 Cervical & Lumbar Fusion Case Series
Introduction
Dr. Jean Louis Benae, MD, FAANS, FICS conducted a case series to assess the efficacy of TriForm™ in cervical and lumbar spinal fusions for patients with advanced degenerative conditions unresponsive to conservative care.
Methods
Seventeen patients (ages 37–61) underwent minimally invasive posterior cervical or lumbar fusion procedures. TriForm™ was mixed with bone marrow aspirate and placed into the surgical site. Radiographic and clinical assessments were performed at 1, 3, and 6 months.
Results
• Successful arthrodesis confirmed in all patients by 6 months
• Symptomatic improvement reported across the cohort
• Radiographs demonstrated clear heterotopic bone formation:
– 1 month: Initial integration visible
– 3 months: Substantial bone progression
– 6 months: Complete fusion achieved
Conclusion
The study demonstrated TriForm™’s reliability in both cervical and lumbar fusion applications. Patients achieved rapid symptomatic relief and radiographic evidence of fusion, positioning TriForm™ as a trusted biologic solution across multiple spinal indications.
Preclinical Histology & Animal Studies
Overview
TriForm™’s performance has been validated in ovine (sheep) animal models. These studies assessed bone-particle integration, osteoblast activity, and collagen matrix formation over time.
Findings
• 3 months: Excellent bone-particle contact observed, with active osteoblasts producing new bone matrix and early collagen deposition.
• 12 months: Strong remodeling confirmed, with positive staining for type I collagen in mineralized bone matrix and osteoblasts actively producing bone. TriForm™ particles showed excellent resorption and replacement with host bone.
Conclusion
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Preclinical histology confirms TriForm™’s ability to support rapid bone ingrowth and remodeling. The combination of β-TCP, silicate, and collagen creates an ideal environment for osteogenesis, validating its role as a next-generation biosynthetic graft.
Clinical Takeaway
Across human case series and preclinical models, TriForm™ has consistently delivered safe, predictable, and complete fusion outcomes. Surgeons can trust TriForm™ to remodel into strong, healthy bone while offering best-in-class handling and reliable patient results.