New pedicle screws for surgery on spinal deformities
The Biomechanics and Clinical Application of Novel Dual-headed Pedicle Screws in the Corrective Surgery for Spinal Deformity
This study is testing new dual-headed screws in surgery for severe spinal deformities to see if they can reduce complications and improve recovery for patients aged 18-70.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06144879 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of novel dual-headed pedicle screws in corrective surgery for severe spinal deformities such as kyphosis and scoliosis. The study aims to address the high rates of rod fractures associated with traditional spinal fixation methods by utilizing a new surgical approach that reinforces the osteotomy area and adjacent segments. Patients aged 18-70 with a Cobb angle greater than 70° who have undergone spinal corrective surgery will be evaluated over a follow-up period of more than 24 months. The trial seeks to improve surgical outcomes and reduce complications related to spinal deformities.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with severe spinal deformities requiring corrective surgery.
Not a fit: Patients who have previously undergone spinal surgery or have incomplete clinical data will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of rod fractures and improve the quality of life for patients with severe spinal deformities.
How similar studies have performed: While traditional methods have shown limitations, this novel approach with dual-headed screws is relatively untested, making it a potentially innovative solution.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. receive spinal corrective surgery from 2015-2020 2. Age: 18-70 years old 3. the Cobb angle of scoliosis or kyphosis more than 70 ° 4. posterior pedicle subtraction osteotomy(PSO), using novel duet screws in three-rod or four-rod group 5. follow-up more than 24 months Exclusion Criteria: 1. previously received spinal surgery 2. clinical and radiographic data preoperatively, postoperatively and last follow up were incomplete
Where this trial is running
Nanjing, Jiangsu
- Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Xiaodong Qin, Ph.D
- Email: qinxd_njumed@163.com
- Phone: 008615298386726
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.