Study on the effect of anterior cervical screw placement position difference on the stability of internal fixation system
| ISRCTN | ISRCTN77678938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77678938 |
- Submission date
- 10/11/2022
- Registration date
- 18/11/2022
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Some scholars have conducted clinical experiments and biomechanical studies on the biomechanical differences between cross and parallel screw placement in anterior cervical discectomy and fusion surgery while treating cervical disc degeneration, and found that the uneven angle of screw placement did not affect the stability of the internal fixation system. However, the different screw placement angles on the stress transfer effect is not described in detail, the stress transfer effect determines the future system stability.
Who can participate?
Healthy adult male volunteers.
What does the study involve?
A CT scan of the spine in different positions.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Shanxi Bethune Hospital (China)
When is the study starting and how long is it expected to run for?
August 2022 to October 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Zejun Xing, 18735130965@163.com
Contact information
Public
No.99 Longcheng Street
Taiyuan
030000
China
| Phone | +86 18735130965 |
|---|---|
| 18735130965@163.com |
Study information
| Study design | Machine learning case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Study on the effect of anterior cervical screw placement position difference on the stability of internal fixation system |
| Study hypothesis | Some scholars have conducted clinical experiments and biomechanical studies on the biomechanical differences between cross and parallel screw placement in anterior cervical discectomy and fusion surgery while treating cervical disc degeneration, and found that the uneven angle of screw placement did not affect the stability of the internal fixation system. However, the different screw placement angles on the stress transfer effect is not described in detail, the stress transfer effect determines the future system stability. |
| Ethics approval(s) | Approved 08/11/2022, Medical Ethics Committee of Shanxi Bethune Hospital (No.99, Longcheng Street, Taiyuan, Shanxi Province, 030000, China; +86 351-8379145; dyyywc@163.com), ref:YXLL-2022-140 |
| Condition | Cervical disc degeneration |
| Intervention | The CT data of the lower cervical spine of volunteers were obtained by 128-row spiral CT scanner. The image data were imported into Mimics software in the format of Dicom to perform threshold division of the data, cavity filling and other operations to generate a complete three-dimensional model of the lower cervical spine including C1-C7 segments, and imported into Geomagic Studio 2016 software in stl format for further denoising, smoothing, and fitting surface processing of the model to form a solid model. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The stress, displacement and stress transfer of the intervertebral disc with different screw placement angles were observed under left bending, upright and anteflexion conditions obtained by 128-row spiral CT scanner at a single time point. |
| Secondary outcome measures | There are no secondary outcome measures. |
| Overall study start date | 01/08/2022 |
| Overall study end date | 01/10/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 1 |
| Participant inclusion criteria | 1. Healthy male volunteers 2. No history of trauma surgery, osteoporosis, bone hyperplasia and other pathological conditions 3. Routine imaging examination to exclude cervical spondylosis disease history 4. Cervical activity in the normal range |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/08/2022 |
| Recruitment end date | 01/08/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Taiyuan
030000
China
Sponsor information
Hospital/treatment centre
No.99, Longcheng Street
Taiyuan
030000
China
| Phone | +86 351-8379146 |
|---|---|
| dyyywc@163.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Zejun Xing, 18735130965@163.com |
Editorial Notes
14/11/2022: Trial's existence confirmed by Medical Ethics Committee of Shanxi Bethune Hospital.
