Impact of Lateral Bone Grafting With Intraoperative Fusion in ACDF on Clinical Outcomes

Cervical Spondylosis Clinical Trial

Official title:

Impact of Lateral Bone Grafting With Intraoperative Fusion in ACDF on Clinical Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06027827
• Other study ID #: XuanwuACDF
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Fengzeng Jian, MD, PhD
• Phone: 135 5206 7268
• Email: fengzengjian[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age between 18-60 years old; patients with cervical spondylosis who were about to undergo 1-2 segment ACDF surgery; agreement with the surgical plan and willingness to undergo long-term clinical follow-up; and signing of an informed consent form.

Exclusion Criteria:

• Drug or alcohol abusers; those with abnormal liver or kidney function unsuitable for surgery; those with cardiac insufficiency unsuitable for surgery; those with severe metabolic and endocrine diseases unsuitable for surgery; those with severe lung disorders such as asthma and abnormal lung function unsuitable for surgery; pregnant and breastfeeding women as well as those who are planning to become pregnant in the near future; those who have participated in other clinical trials within 3 months; and those who are not suitable for participation in the experiment in the opinion of the investigator.

Related Conditions & MeSH terms

• Cervical Spondylosis
• Spondylosis

Intervention

Procedure:
• Addition of fusion device lateral bone graft
In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.2018.11.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervertebral bone fusion rate	primary Indicator	3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) postoperatively
Secondary	JOA	Japanese Orthopaedic Association Scores	Preoperative, 7 days postoperative, 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days)