Cervical Spondylosis
Conditions
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.
Interventions
PROCEDUREAddition 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.
Sponsors
Xuanwu Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervertebral bone fusion rate | 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) postoperatively | primary Indicator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| JOA | Preoperative, 7 days postoperative, 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) | Japanese Orthopaedic Association Scores |
Countries
China
Contacts
Primary ContactFengzeng Jian, MD, PhD
Outcome results
None listed