Investigating the effects of lateral bone grafting during ACDF surgery on patient outcomes
Impact of Lateral Bone Grafting With Intraoperative Fusion in ACDF on Clinical Outcomes
This study is testing if using lateral bone grafts during neck surgery can help improve recovery and fusion success for patients with cervical spondylosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06027827 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and efficacy of lateral bone grafting in anterior cervical discectomy and fusion (ACDF) procedures for patients with cervical spondylosis. It involves the implantation of allograft bone in the joint space adjacent to the fusion device during surgery. Clinical outcomes and intervertebral bony fusion rates will be assessed through X-rays and CT scans at various postoperative intervals. The study will include patients aged 18-60 who are scheduled for 1-2 segment ACDF surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with cervical spondylosis scheduled for 1-2 segment ACDF surgery.
Not a fit: Patients with severe comorbidities or those unsuitable for surgery, such as drug or alcohol abusers, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance bony fusion rates and improve clinical outcomes for patients undergoing ACDF surgery.
How similar studies have performed: While the specific approach of lateral bone grafting in ACDF may be novel, similar studies have shown promising results in enhancing fusion rates in spinal surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Fengzeng Jian, MD, PhD
- Email: fengzengjian@hotmail.com
- Phone: 135 5206 7268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.