Osteocel Plus cellular allograft in anterior cervical discectomy and fusion: evaluation of clinical and radiographic outcomes from a prospective multicenter study

Prospective, multicenter, nonrandomized, institutional review board-approved clinical and radiographic study. To evaluate and summarize the 2-year outcomes of patients treated with Osteocel Plus cellular allograft as part of an anterior cervical discectomy and fusion procedure. Osteocel Plus is an a...

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Veröffentlicht in:	Spine (Philadelphia, Pa. 1976) Jg. 39; H. 22; S. E1331
Hauptverfasser:	Eastlack, Robert K, Garfin, Steven R, Brown, Christopher R, Meyer, S Craig
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States 15.10.2014
Schlagworte:	Allografts Blood Loss, Surgical Bone Matrix - transplantation Cervical Vertebrae - diagnostic imaging Cervical Vertebrae - surgery Disability Evaluation Diskectomy - methods Female Humans Length of Stay Male Mental Health Mesenchymal Stem Cell Transplantation Middle Aged Neck Pain - etiology Operative Time Pain Measurement Patient Satisfaction Prospective Studies Radiography Range of Motion, Articular Spinal Diseases - complications Spinal Diseases - diagnostic imaging Spinal Diseases - surgery Spinal Fusion - methods Treatment Outcome
ISSN:	1528-1159, 1528-1159
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Abstract	Prospective, multicenter, nonrandomized, institutional review board-approved clinical and radiographic study. To evaluate and summarize the 2-year outcomes of patients treated with Osteocel Plus cellular allograft as part of an anterior cervical discectomy and fusion procedure. Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells and osteoprogenitor cells that is intended to mimic the performance of iliac crest autograft without the morbidity associated with its harvest. A total of 182 patients were treated with anterior cervical discectomy and fusion using Osteocel Plus in a polyetheretherketone cage and anterior plating at 1 or 2 consecutive levels. Clinical outcomes included visual analogue scale for neck and arm pain, neck disability index, and SF-12 physical and mental component scores. Computed tomography and plain film radiographic measures included assessment of bridging bone, disc height, disc angle, and segmental range of motion. A total of 249 levels were treated in 182 patients. Mean procedure time was 100 minutes, blood loss was less than 50 mL in 93% of patients, and hospital stay was 1 day or less in 84% of patients. Significant (P<0.05) average improvements in clinical outcomes from preoperatively to 24 months included the following: neck disability index: 21.5%; visual analogue scale neck: 34 mm; visual analogue scale arm: 35 mm; SF-12 physical component score: 11.2; SF-12 mental component score: 6.8. At 24 months, 93% of patients were satisfied with their outcome. In patients treated at a single level with a minimum of 24-month follow-up, 92% (79/86) of levels achieved solid bridging and 95% of levels demonstrated range of motion of less than 3°. In combined single- and 2-level procedures, 87% (157/180) of levels achieved solid bridging and 92% (148/161) had range of motion of less than 3° at 24 months. No patient required revision for pseudarthrosis. Improvements in clinical results at 2 years, high patient satisfaction, and high radiographic and clinical fusion rates provide confidence in Osteocel Plus as an effective alternative to structural allograft or autograft in anterior cervical discectomy and fusion procedures. 4.
AbstractList	Prospective, multicenter, nonrandomized, institutional review board-approved clinical and radiographic study.STUDY DESIGNProspective, multicenter, nonrandomized, institutional review board-approved clinical and radiographic study.To evaluate and summarize the 2-year outcomes of patients treated with Osteocel Plus cellular allograft as part of an anterior cervical discectomy and fusion procedure.OBJECTIVETo evaluate and summarize the 2-year outcomes of patients treated with Osteocel Plus cellular allograft as part of an anterior cervical discectomy and fusion procedure.Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells and osteoprogenitor cells that is intended to mimic the performance of iliac crest autograft without the morbidity associated with its harvest.SUMMARY OF BACKGROUND DATAOsteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells and osteoprogenitor cells that is intended to mimic the performance of iliac crest autograft without the morbidity associated with its harvest.A total of 182 patients were treated with anterior cervical discectomy and fusion using Osteocel Plus in a polyetheretherketone cage and anterior plating at 1 or 2 consecutive levels. Clinical outcomes included visual analogue scale for neck and arm pain, neck disability index, and SF-12 physical and mental component scores. Computed tomography and plain film radiographic measures included assessment of bridging bone, disc height, disc angle, and segmental range of motion.METHODSA total of 182 patients were treated with anterior cervical discectomy and fusion using Osteocel Plus in a polyetheretherketone cage and anterior plating at 1 or 2 consecutive levels. Clinical outcomes included visual analogue scale for neck and arm pain, neck disability index, and SF-12 physical and mental component scores. Computed tomography and plain film radiographic measures included assessment of bridging bone, disc height, disc angle, and segmental range of motion.A total of 249 levels were treated in 182 patients. Mean procedure time was 100 minutes, blood loss was less than 50 mL in 93% of patients, and hospital stay was 1 day or less in 84% of patients. Significant (P<0.05) average improvements in clinical outcomes from preoperatively to 24 months included the following: neck disability index: 21.5%; visual analogue scale neck: 34 mm; visual analogue scale arm: 35 mm; SF-12 physical component score: 11.2; SF-12 mental component score: 6.8. At 24 months, 93% of patients were satisfied with their outcome. In patients treated at a single level with a minimum of 24-month follow-up, 92% (79/86) of levels achieved solid bridging and 95% of levels demonstrated range of motion of less than 3°. In combined single- and 2-level procedures, 87% (157/180) of levels achieved solid bridging and 92% (148/161) had range of motion of less than 3° at 24 months. No patient required revision for pseudarthrosis.RESULTSA total of 249 levels were treated in 182 patients. Mean procedure time was 100 minutes, blood loss was less than 50 mL in 93% of patients, and hospital stay was 1 day or less in 84% of patients. Significant (P<0.05) average improvements in clinical outcomes from preoperatively to 24 months included the following: neck disability index: 21.5%; visual analogue scale neck: 34 mm; visual analogue scale arm: 35 mm; SF-12 physical component score: 11.2; SF-12 mental component score: 6.8. At 24 months, 93% of patients were satisfied with their outcome. In patients treated at a single level with a minimum of 24-month follow-up, 92% (79/86) of levels achieved solid bridging and 95% of levels demonstrated range of motion of less than 3°. In combined single- and 2-level procedures, 87% (157/180) of levels achieved solid bridging and 92% (148/161) had range of motion of less than 3° at 24 months. No patient required revision for pseudarthrosis.Improvements in clinical results at 2 years, high patient satisfaction, and high radiographic and clinical fusion rates provide confidence in Osteocel Plus as an effective alternative to structural allograft or autograft in anterior cervical discectomy and fusion procedures.CONCLUSIONImprovements in clinical results at 2 years, high patient satisfaction, and high radiographic and clinical fusion rates provide confidence in Osteocel Plus as an effective alternative to structural allograft or autograft in anterior cervical discectomy and fusion procedures.4.LEVEL OF EVIDENCE4. Prospective, multicenter, nonrandomized, institutional review board-approved clinical and radiographic study. To evaluate and summarize the 2-year outcomes of patients treated with Osteocel Plus cellular allograft as part of an anterior cervical discectomy and fusion procedure. Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells and osteoprogenitor cells that is intended to mimic the performance of iliac crest autograft without the morbidity associated with its harvest. A total of 182 patients were treated with anterior cervical discectomy and fusion using Osteocel Plus in a polyetheretherketone cage and anterior plating at 1 or 2 consecutive levels. Clinical outcomes included visual analogue scale for neck and arm pain, neck disability index, and SF-12 physical and mental component scores. Computed tomography and plain film radiographic measures included assessment of bridging bone, disc height, disc angle, and segmental range of motion. A total of 249 levels were treated in 182 patients. Mean procedure time was 100 minutes, blood loss was less than 50 mL in 93% of patients, and hospital stay was 1 day or less in 84% of patients. Significant (P<0.05) average improvements in clinical outcomes from preoperatively to 24 months included the following: neck disability index: 21.5%; visual analogue scale neck: 34 mm; visual analogue scale arm: 35 mm; SF-12 physical component score: 11.2; SF-12 mental component score: 6.8. At 24 months, 93% of patients were satisfied with their outcome. In patients treated at a single level with a minimum of 24-month follow-up, 92% (79/86) of levels achieved solid bridging and 95% of levels demonstrated range of motion of less than 3°. In combined single- and 2-level procedures, 87% (157/180) of levels achieved solid bridging and 92% (148/161) had range of motion of less than 3° at 24 months. No patient required revision for pseudarthrosis. Improvements in clinical results at 2 years, high patient satisfaction, and high radiographic and clinical fusion rates provide confidence in Osteocel Plus as an effective alternative to structural allograft or autograft in anterior cervical discectomy and fusion procedures. 4.
Author	Eastlack, Robert K Meyer, S Craig Brown, Christopher R Garfin, Steven R
Author_xml	– sequence: 1 givenname: Robert K surname: Eastlack fullname: Eastlack, Robert K organization: Scripps Health, La Jolla, CA †University of California San Diego, San Diego, CA ‡Duke University Medical Center, Durham, NC; and §Columbia Orthopaedic Group, Columbia, MO – sequence: 2 givenname: Steven R surname: Garfin fullname: Garfin, Steven R – sequence: 3 givenname: Christopher R surname: Brown fullname: Brown, Christopher R – sequence: 4 givenname: S Craig surname: Meyer fullname: Meyer, S Craig
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SubjectTerms	Allografts Blood Loss, Surgical Bone Matrix - transplantation Cervical Vertebrae - diagnostic imaging Cervical Vertebrae - surgery Disability Evaluation Diskectomy - methods Female Humans Length of Stay Male Mental Health Mesenchymal Stem Cell Transplantation Middle Aged Neck Pain - etiology Operative Time Pain Measurement Patient Satisfaction Prospective Studies Radiography Range of Motion, Articular Spinal Diseases - complications Spinal Diseases - diagnostic imaging Spinal Diseases - surgery Spinal Fusion - methods Treatment Outcome
Title	Osteocel Plus cellular allograft in anterior cervical discectomy and fusion: evaluation of clinical and radiographic outcomes from a prospective multicenter study
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