The lateral borders of the disc were exposed along with the traversing and exiting nerve roots. An open posterior interbody lumbar fusion procedure and a partial laminectomy with facetectomies were performed in each patient. Patients were anesthetized, placed in a prone position on a Jackson spinal frame, with extension of the lumbar spine and legs to preserve lumbar lordosis, prepped, and draped. Complications and adverse events were recorded. Fusion was defined as an absence of radiolucent lines adjacent to interbody implant and evidence of bridging trabecular bone within the cages. Fusion was evaluated for material within the control (autograft) and study (ABM/P-15) cages. Two independent, blinded radiologists interpreted all radiographs and CTs. Radiographs (3, 6, 12 and 24 months) and CT (6, 12 and 24 month) were used to assess fusion. VAS scale for back pain and leg pain, Oswestry Disability Index were conducted preoperatively, post-treatment, and at the 3, 6, 12, and 24 month intervals. Patients had to be between 18 to 70 years of age, and psychosocially, mentally, and physically able to comply with the protocol, including follow-up schedules and requirements.Įxclusion criteria were sensitivity to components of the P-15 bone putty, active infection at the operative site, operative site subject to excessive impact or stress, significant vascular impairment proximal to the graft site, use of graft in direct contact with articular spaces, presence of segmental defects, metabolic or systemic bone disorders that affect bone or wound healing, pregnancy/nursing, compromised renal function, compromised immunological system, inability to follow postoperative protocol, history of substance abuse, prisoner, or currently participating in another research project. Inclusion criteria were the presence of disc pathology, spinal stenosis, maximum grade 1 isthmic or degenerative spondylolisthesis, and revision of non-union, adjacent level degeneration, or post-discectomy revision between L2 and S1. Local autograft bone was placed inside one cage and ABM/P-15Bone Graft in the other cage for each vertebral level treated. With the patient as control, each patient received two paired coLigne ostaPek cages (coLigne, Zurich, Switzerland). Patients were screened for eligibility, provided informed consent, and randomized according to birthdate (odd, left even, right). The study received ethics committee approval of the Hospital and the University of Antwerp. The study hypothesized non-inferiority of ABM/P-15 efficacy and safety compared to autograft for use in PLIF.īetween June 2009 and February 2010, forty patients with varying indications unresponsive to conservative care underwent PLIF surgery with pedicle screw instrumentation performed by an experienced investigator at a single center (Regionaal Ziekenhuis Sint-Trudo, Sint-Truiden, Belgium).
Ifactor bone graft trial#
This study is the first prospective, controlled, long-term trial performed to date on ABM/ P-15 for use in PLIF. 14ġ5 ABM/P-15 was originally developed and approved by the FDA for use in dental applications, with demonstrated clinical superiority to both demineralized bone matrix and allograft 18ġ9 and a solid safety profile and it has been in human clinical use in periodontal osseous defects for more than a decade. This study seeks to add to the dialogue by evaluating the clinical results, safety, and efficacy of a novel osteobiologic peptide enhanced bone graft material (i-FACTOR, Cerapedics Inc., Westminster, Colorado USA) for use in PLIF.ĪBM/P-15 combines anorganic bone mineral (ABM, a natural defect hydroxyapatite) and P-15, a synthetic 15 amino acid polypeptide which acts as an attachment factor for osteogenic cells 13– 17 and which stimulates new bone formation. 8– 12 Clinicians and researchers continue to explore bone graft alternatives that are safe, economical, and comparably effective to autologous bone. 6ħ One promising alternative, rhBMP-2, has recently come under increased scrutiny.
There are a variety of bone graft substitutes available.
2 While autologous bone remains the gold standard for bone graft material in PLIF, associated risks of graft site morbidity ranging up to 25.3%, including chronic pain and other complications, have been well documented. 1 When degenerative disease is the cause and unresponsive to conservative therapies, posterior lumbar interbody fusion (PLIF) is an effective surgical technique to address chronic pain. Low back pain is common, with a lifetime incidence of 85%.
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