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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cervical Spondylosis

Intervention / Treatment
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* Procedure: Addition of fusion device lateral bone graft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| experimental group<br>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<br>* In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added.<br>|
| control group<br>Conventional bone grafting in the center of the fusion | |

What is the study measuring?
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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) |