Evaluating anterior cervical spine surgery for cervical disc degeneration
Efficacy and Safety of Anterior Cervical Spine Surgery in Patients With Cervical Degenerative Disc Disease - a Real World Data Collection and Analysis Study
This study is testing if anterior cervical spine surgery can help people with cervical disc degeneration feel better and stay safe during recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05602714 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of anterior cervical spine surgery in patients diagnosed with cervical degenerative disc disease. It utilizes an ambispective cohort design, where patients will be selected based on their clinical symptoms and imaging results. Various scales, including the Visual Analogue Scale and Japanese Orthopaedic Association Scale, will be employed to record outcomes and any adverse events related to the procedure. The data collected will be analyzed to determine the effectiveness of the surgical intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have cervical degenerative disc disease and have not responded to at least three months of conservative treatment.
Not a fit: Patients with non-degenerative conditions or neuromuscular diseases, as well as those contraindicated for cervical spine imaging, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of anterior cervical spine surgery, potentially improving treatment options for patients with cervical degenerative disc disease.
How similar studies have performed: While this study focuses on real-world data collection, similar observational studies have shown promising results in evaluating surgical outcomes for cervical degenerative conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients over 18 years old 2. Clinical symptoms and imaging support cervical degenerative disc disease； 3. Failed a minimum of 3months conservative treatment 4. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) anterior cervical spine surgery 5. Written informed consent given by subject Exclusion Criteria: 1. Patients with non-degenerative (e.g., trauma, tumor, and infection) or neuromuscular diseases (e.g., motor neuron disease) were excluded 2. Patients with cervical spine X-ray film and CT scan contraindications 3. Women who are lactating and pregnant
Where this trial is running
Beijing, Beijing
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Bingxuan Dr. Wu, PhD
- Email: bingxuanwoo@163.com
- Phone: +8615210063292
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.