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

Recruiting
Conditions
Cervical Spondylosis
Registration Number
NCT06027827
Lead Sponsor
Xuanwu Hospital, Beijing
Brief 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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
58
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Intervertebral bone fusion rate3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) postoperatively

primary Indicator

Secondary Outcome Measures
NameTimeMethod
JOAPreoperative, 7 days postoperative, 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days)

Japanese Orthopaedic Association Scores

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University

🇨🇳

Beijing, Beijing, China

Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Fengzeng jian, MD,PhD
Contact
135 5206 7268
fengzengjian@hotmail.com

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