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The purpose of this trial was to investigate the safety and efficacy of fuser lateral bone grafting in ACDF. By observing the intervertebral bony fusion rate and clinical outcome scores of patients after fusion device lateral bone grafting, it was verified whether the fusion device lateral bone grafting approach could improve the bony fusion rate and clinical outcome of ACDF.
The study will include patients who underwent 1-2 segment ACDF surgery, in addition to conventional surgical operations, the appropriate amount of allograft bone was implanted in the joint space of the hook vertebrae lateral to the fusion device, and X-rays and CTs were reviewed in the immediate postoperative period, March, June, and December, to verify intervertebral osseous fusion, as well as to observe the patient's clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added. |
| |
| control group | Conventional bone grafting in the center of the fusion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Addition of fusion device lateral bone graft | Procedure | In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intervertebral bone fusion rate | primary Indicator | 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| JOA | Japanese Orthopaedic Association Scores | Preoperative, 7 days postoperative, 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) |
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Inclusion Criteria:
Exclusion Criteria:
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Between the ages of 18-60 years; patients with cervical spondylosis about to undergo 1-2 segment ACDF surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fengzeng Jian, MD, PhD | Contact | 135 5206 7268 | fengzengjian@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fengzeng Jian, MD, PhD | Xuanwu Hospital, Beijing | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31528438 | Result | Epstein NE. A Review of Complication Rates for Anterior Cervical Diskectomy and Fusion (ACDF). Surg Neurol Int. 2019 Jun 7;10:100. doi: 10.25259/SNI-191-2019. eCollection 2019. | |
| 17906571 | Result | Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e. |
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| ID | Term |
|---|---|
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 30692036 | Result | Wewel JT, Kasliwal MK, Adogwa O, Deutsch H, O'Toole JE, Traynelis VC. Fusion rate following three- and four-level ACDF using allograft and segmental instrumentation: A radiographic study. J Clin Neurosci. 2019 Apr;62:142-146. doi: 10.1016/j.jocn.2018.11.040. Epub 2019 Jan 25. |
| 35471708 | Result | Godlewski B, Bebenek A, Dominiak M, Karpinski G, Cieslik P, Pawelczyk T. PEEK versus titanium-coated PEEK cervical cages: fusion rate. Acta Neurochir (Wien). 2022 Jun;164(6):1501-1507. doi: 10.1007/s00701-022-05217-7. Epub 2022 Apr 26. |
| 15541695 | Result | Samartzis D, Shen FH, Lyon C, Phillips M, Goldberg EJ, An HS. Does rigid instrumentation increase the fusion rate in one-level anterior cervical discectomy and fusion? Spine J. 2004 Nov-Dec;4(6):636-43. doi: 10.1016/j.spinee.2004.04.010. |