title: A prospective, multi-center clinical and radiographic outcomes evaluation of ChronOS strip for lumbar spine fusion.
abstract: This prospective clinical study evaluated the use of a composite bone void filler (ChronOS Strip, DePuy Synthes, West Chester, PA, USA), combined with bone marrow aspirate plus local autologous bone, in a series of patients undergoing instrumented posterolateral spinal fusion with interbody support. Seventy-six patients were enrolled and treated per protocol at 13 clinical sites. At 24 months, 55/76 patients (72%) were evaluated, with 49/76 (65%) having sufficient data to determine the primary endpoint. The primary endpoint, posterolateral fusion success, was achieved in 48/54 (88.9%) patients at 12 months and in 45/49 (91.8%) patients at 24 months. At all follow-up time points, statistically significant improvements were observed when compared to baseline in back and leg pain and functional status as measured by visual analog scale, Oswestry Disability Index and 12-Item Short Form health surveys. This prospective multi-center series provides evidence that the composite bone void filler, when applied posterolaterally with instrumentation, bone marrow aspirate and/or local autologous bone and concomitant interbody support, can be used to achieve a successful posterolateral fusion, resulting in improvements in clinical outcomes in patients with degenerative disc disease.
authors.affiliation: Department of Neurosurgery, University of Pittsburgh Medical Center, Suite B-400, 200 Lothrop Street, Pittsburgh, PA 15213, USA.
authors.forename: Adam S
authors.initials: AS
authors.lastname: Kanter
authors.affiliation: Department of Neurosurgery, University of Pittsburgh Medical Center, Suite B-400, 200 Lothrop Street, Pittsburgh, PA 15213, USA. Electronic address: gandhokegs@upmc.edu.
authors.forename: Gurpreet S
authors.initials: GS
authors.lastname: Gandhoke
authors.affiliation: Department of Neurosurgery, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: William C
authors.initials: WC
authors.lastname: Welch
authors.affiliation: Department of Neurosurgery, University of Kansas Medical Center, Kansas City, KS, USA.
authors.forename: Paul M
authors.initials: PM
authors.lastname: Arnold
authors.affiliation: Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, TN, USA.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Cheng
authors.affiliation: Department of Neurosurgery, University of Pittsburgh Medical Center, Suite B-400, 200 Lothrop Street, Pittsburgh, PA 15213, USA.
authors.forename: David O
authors.initials: DO
authors.lastname: Okonkwo
mesh_terms: D000328:Adult; D016025:Bone Transplantation; D005260:Female; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D013123:Spinal Fusion / Q000379:methods*; D014182:Transplantation, Autologous; D016896:Treatment Outcome
keywords: Beta-tricalcium phosphates; Bone marrow aspirate; Posterolateral fusion