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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Spondylosis
• Intervention / Treatment: Procedure: Addition of fusion device lateral bone graft

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 58

Contacts and Locations

• Study Contact: Name: Fengzeng Jian, MD, PhD; Phone Number: 135 5206 7268; Email: fengzengjian@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Fengzeng jian, MD,PhD; Phone Number: 135 5206 7268; Email: fengzengjian@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Between the ages of 18-60 years; patients with cervical spondylosis about to undergo 1-2 segment ACDF surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
experimental group; In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added.	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.
control group; Conventional bone grafting in the center of the fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervertebral bone fusion rate	primary Indicator	3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) postoperatively

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Study Chair: Fengzeng Jian, MD, PhD, Xuanwu Hospital, Beijing

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylosis
• Other Study ID Numbers: XuanwuACDF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No