{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,25]],"date-time":"2026-01-25T08:31:33Z","timestamp":1769329893324,"version":"3.49.0"},"reference-count":41,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["SPI"],"published-print":{"date-parts":[[2016,9]]},"abstract":"\nOBJECTIVE<\/jats:title>\nHeterotopic ossification (HO) has been reported following total hip, knee, cervical, and lumbar arthroplasty, as well as following posterolateral lumbar fusion using recombinant human bone morphogenetic protein\u20132 (rhBMP-2). Data regarding HO following anterior cervical discectomy and fusion (ACDF) with rhBMP-2 are sparse. A subanalysis was done of the prospective, multicenter, investigational device exemption trial that compared rhBMP-2 on an absorbable collagen sponge (ACS) versus allograft in ACDF for patients with symptomatic single-level cervical degenerative disc disease.<\/jats:p><\/jats:sec>\n\nMETHODS<\/jats:title>\nTo assess differences in types of HO observed in the treatment groups and effects of HO on functional and efficacy outcomes, clinical outcomes from previous disc replacement studies were compared between patients who received rhBMP-2\/ACS versus allograft. Rate, location, grade, and size of ossifications were assessed preoperatively and at 24 months, and correlated with clinical outcomes.<\/jats:p><\/jats:sec>\n\nRESULTS<\/jats:title>\nHeterotopic ossification was primarily anterior in both groups. Preoperatively in both groups, and including osteophytes in the target regions, HO rates were high at 40.9% and 36.9% for the rhBMP-2\/ACS and allograft groups, respectively (p = 0.350). At 24 months, the rate of HO in the rhBMP-2\/ACS group was higher than in the allograft group (78.6% vs 59.2%, respectively; p < 0.001). At 24 months, the rate of superior-anterior adjacent-level Park Grade 3 HO was 4.2% in both groups, whereas the rate of Park Grade 2 HO was 19.0% in the rhBMP-2\/ACS group compared with 9.8% in the allograft group. At 24 months, the rate of inferior-anterior adjacent-level Park Grade 2\/3 HO was 11.9% in the rhBMP-2\/ACS group compared with 5.9% in the allograft group. At 24 months, HO rates at the target implant level were similar (p = 0.963). At 24 months, the mean length and anteroposterior diameter of HO were significantly greater in the rhBMP-2\/ACS group compared with the allograft group (p = 0.033 and 0.012, respectively). Regarding clinical correlation, at 24 months in both groups, Park Grade 3 HO at superior adjacent-level disc spaces significantly reduced range of motion, more so in the rhBMP-2\/ACS group. At 24 months, HO negatively affected Neck Disability Index scores (excluding neck\/arm pain scores), neurological status, and overall success in patients in the rhBMP-2\/ACS group, but not in patients in the allograft group.<\/jats:p><\/jats:sec>\n\nCONCLUSIONS<\/jats:title>\nImplantation of rhBMP-2\/ACS at 1.5 mg\/ml with polyetheretherketone spacer and titanium plate is effective in inducing fusion and improving pain and function in patients undergoing ACDF for symptomatic single-level cervical degenerative disc disease. At 24 months, the rate and dimensions (length and anteroposterior diameter) of HO were higher in the rhBMP-2\/ACS group. At 24 months, range of motion was reduced, with Park Grade 3 HO in both treatment groups. The impact of Park Grades 2 and 3 HO on Neck Disability Index success, neurological status, and overall success was not consistent among the treatment groups. The study data may offer a deeper understanding of HO after ACDF and may pave the way for improved device designs.<\/jats:p>\nClinical trial registration no.: IDE# G060021; data compared with pooled data from control arms of IDE# G010188\/NCT00642876 and IDE# G000123\/NCT00437190 (www.clinicaltrials.gov<\/jats:ext-link>).<\/jats:p><\/jats:sec>","DOI":"10.3171\/2016.1.spine15798","type":"journal-article","created":{"date-parts":[[2016,4,29]],"date-time":"2016-04-29T14:10:29Z","timestamp":1461939029000},"page":"292-302","source":"Crossref","is-referenced-by-count":18,"title":["Heterotopic ossification following single-level anterior cervical discectomy and fusion: results from the prospective, multicenter, historically controlled trial comparing allograft to an optimized dose of rhBMP-2"],"prefix":"10.3171","volume":"25","author":[{"given":"Paul M.","family":"Arnold","sequence":"first","affiliation":[{"name":"Department of Neurosurgery, University of Kansas Medical Center, Kansas City, Kansas;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen K.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, University of Kansas Medical Center, Kansas City, Kansas;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abdulhafez","family":"Selim","sequence":"additional","affiliation":[{"name":"Medtronic Spinal and Biologics, Memphis, Tennessee;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Randall F.","family":"Dryer","sequence":"additional","affiliation":[{"name":"Central Texas Spine Institute, Austin, Texas;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Kenneth Burkus","sequence":"additional","affiliation":[{"name":"The Hughston Clinic; and"},{"name":"Wilderness Spine Services, Columbus, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1754","reference":[{"key":"b1-spine15798","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"E502","DOI":"10.1097\/BRS.0b013e318238870b","article-title":"Heterotopic ossification associated with recombinant human bone morphogenetic protein-2 (infuse) in posterolateral lumbar spine fusion: a case report","volume":"37","author":"Anderson","year":"2012"},{"key":"b2-spine15798","series-title":"Spinal Cord","doi-asserted-by":"publisher","first-page":"370","DOI":"10.1038\/sj.sc.3101166","article-title":"Prevention of heterotopic ossification after spinal cord injury with indomethacin","volume":"39","author":"Banovac","year":"2001"},{"key":"b3-spine15798","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1219","DOI":"10.1097\/01.BRS.0000065486.22141.CA","article-title":"A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate","volume":"28","author":"Baskin","year":"2003"},{"key":"b4-spine15798","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"841","DOI":"10.1007\/s00586-009-1017-6","article-title":"Intermediate clinical and radiological results of cervical TDR (Mobi-C) with up to 2 years of follow-up","volume":"18","author":"Beaurain","year":"2009"},{"key":"b5-spine15798","series-title":"J Neurosurg Spine","doi-asserted-by":"publisher","first-page":"141","DOI":"10.3171\/2012.4.SPINE12223","article-title":"High prevalence of heterotopic ossification after cervical disc arthroplasty: outcome and intraoperative findings following explantation of 22 cervical disc prostheses","volume":"17","author":"Brenke","year":"2012"},{"key":"b6-spine15798","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"E653","DOI":"10.1097\/BRS.0b013e31817c4f1c","article-title":"A case of psoas ossification from the use of BMP-2 for posterolateral fusion at L4\u2013L5","volume":"33","author":"Brower","year":"2008"},{"key":"b7-spine15798","series-title":"J Bone Joint Surg Br","first-page":"700","article-title":"Heterotopic ossification prophylaxis with indomethacin increases the risk of long-bone nonunion","volume":"85","author":"Burd","year":"2003"},{"key":"b8-spine15798","series-title":"Arch Orthop Trauma Surg","doi-asserted-by":"publisher","first-page":"473","DOI":"10.1007\/s00402-013-1689-6","article-title":"Clinical and radiological follow-up of single-level Prestige LP cervical disc replacement","volume":"133","author":"Chen","year":"2013"},{"key":"b9-spine15798","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"674","DOI":"10.1007\/s00586-011-2094-x","article-title":"Prevalence of heterotopic ossification after cervical total disc arthroplasty: a meta-analysis","volume":"21","author":"Chen","year":"2012"},{"key":"b10-spine15798","series-title":"Clin Orthop Relat Res","doi-asserted-by":"publisher","first-page":"3408","DOI":"10.1007\/s11999-011-2039-z","article-title":"Superiority of the Bryan\u00ae disc prosthesis for cervical myelopathy: a randomized study with 3-year followup","volume":"469","author":"Cheng","year":"2011"},{"key":"b11-spine15798","series-title":"Acta Neurochir (Wien)","doi-asserted-by":"publisher","first-page":"1017","DOI":"10.1007\/s00701-012-1309-1","article-title":"Uncovertebral hypertrophy is a significant risk factor for the occurrence of heterotopic ossification after cervical disc replacement: survivorship analysis of Bryan disc for single-level cervical arthroplasty","volume":"154","author":"Chung","year":"2012"},{"key":"b12-spine15798","series-title":"J Neurosurg Spine","doi-asserted-by":"publisher","first-page":"715","DOI":"10.3171\/2010.5.SPINE09852","article-title":"Prospective study of cervical arthroplasty in 98 patients involved in 1 of 3 separate investigational device exemption studies from a single investigational site with a minimum 2-year follow-up. 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