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Lumbar degenerative disease is a common disease among middle-aged and elderly people as well as those who sit for a long time, mainly manifested as symptoms such as lower back pain, stiffness, and numbness in the lower limbs. Traditional surgical treatments such as lumbar fusion can alleviate symptoms, but may lead to complications such as adjacent segment degeneration. Therefore, exploring safer and more effective treatment methods is of great significance. Topping off technique, as a new treatment method, combines the advantages of interbody fusion and dynamic fixation, aiming to reduce the pressure on the intervertebral disc at the surgical site, promote the repair of diseased intervertebral discs, while preserving partial mobility of the lumbar spine.The aim of this study is to evaluate the clinical efficacy and imaging changes of Topping off technique in the treatment of lumbar degenerative diseases. The Topping off technique combines posterior lumbar interbody fusion (PLIF) and Wallis interspinous dynamic fixation device implantation. Through prospective clinical trials, its therapeutic effect on patients with continuous double segment lumbar degenerative diseases was observed. The study included patients who underwent surgery for degenerative lumbar diseases in L4-5 and L5-S1, who were treated with two-stage fusion surgery and Topping off technique, respectively. Follow up was conducted before and after surgery, with an average follow-up time of 24 months. Evaluate preoperative and postoperative efficacy using Oswestry Disability Index (ODI), Pain Visual Analog Scale (VAS), and Japanese Orthopaedic Association (JOA) lumbar spine function score, and calculate recovery rate. At the same time, X-ray and MRI images were used to detect the overall range of motion (L2~S1ROM) of the lumbar spine, the range of motion (ROM) of the Wallis device inserted segments, the intervertebral disc height index (DHI), and the relative signal intensity of the nucleus pulposus (RSI) of the intervertebral disc.
The aim of this study is to evaluate the clinical efficacy and imaging changes of Topping off technique in the treatment of lumbar degenerative diseases. The Topping off technique combines posterior lumbar interbody fusion (PLIF) and Wallis interspinous dynamic fixation device implantation. Through prospective clinical trials, its therapeutic effect on patients with continuous double segment lumbar degenerative diseases was observed. The study included patients who underwent surgery for degenerative lumbar diseases in L4-5 and L5-S1, who were treated with two-stage fusion surgery and Topping off technique, respectively. Follow up was conducted before and after surgery, with an average follow-up time of 24 months. Evaluate preoperative and postoperative efficacy using Oswestry Disability Index (ODI), Pain Visual Analog Scale (VAS), and Japanese Orthopaedic Association (JOA) lumbar spine function score, and calculate recovery rate. At the same time, X-ray and MRI images were used to detect the overall range of motion (L2~S1ROM) of the lumbar spine, the range of motion (ROM) of the Wallis device inserted segments, the intervertebral disc height index (DHI), and the relative signal intensity of the nucleus pulposus (RSI) of the intervertebral disc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topping-off group | Experimental | Topping-off group Patients who have undergone the Topping-off surgery for lumbar spondylosis and have complete follow-up data and meet the standards completed at the First Affiliated Hospital of Shandong First Medical University. |
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| Fusion group | Active Comparator | Patients who have undergone lumbar spine fusion surgery due to lumbar spondylosis and meet the standards and have complete follow-up data completed at the First Affiliated Hospital of Shandong First Medical University. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topping-off Group | Procedure | Topping-off group Patients who have undergone the Topping-off system insertion surgery for lumbar spondylosis and have complete follow-up data and meet the standards completed at the First Affiliated Hospital of Shandong First Medical University. Fusion group Patients who have undergone lumbar spine fusion surgery due to lumbar spondylosis and meet the standards and have complete follow-up data completed at the First Affiliated Hospital of Shandong First Medical University. |
| Measure | Description | Time Frame |
|---|---|---|
| VAS | The visual analog scale (VAS) is used for pain assessment. It is widely used in clinical practice in China, and the basic method is to use a vernier ruler with a length of about 10cm, marked with 10 scales on one side, with both ends - Page 3 of 5 [DRAFT] - The visual analog scale (VAS) is used for pain assessment. It is widely used in clinical practice in China, and the basic method is to use a vernier ruler with a length of about 10cm, marked with 10 scales on one side, with both ends marked as "0" and "10" respectively. A score of 0 indicates painlessness, and a score of 10 represents the most severe pain that cannot be tolerated. pain that cannot be tolerated. | 2 Years |
| JOA | The Japanese Orthopaedic Association Scores (JOA) is a neurological function scoring system recommended by the Japanese Orthopaedic Association, which includes four parts: upper limb motor function, lower limb motor function, sensory and bladder function, with a total score of 29 points. The lower the score, the more severe the neurological dysfunction. | 2 Years |
| Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position | Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar spine overall range of motion (L2~S1ROM) | Lumbar spine overall range of motion (L2~S1ROM) | 2 Years |
| Wallis device insertion segment mobility (ROM) | Wallis device insertion segment mobility (ROM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao-Xuan Zhang, Ph.D/MD | Contact | CN+86+15275105665 | hoho0605@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Hao-Xuan Zhang, Ph.D/MD | Shandong First Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 250000 | China |
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| Fusion Group | Procedure | Topping-off group Patients who have undergone the Topping-off system insertion surgery for lumbar spondylosis and have complete follow-up data and meet the standards completed at the First Affiliated Hospital of Shandong First Medical University. Fusion group Patients who have undergone lumbar spine fusion surgery due to lumbar spondylosis and meet the standards and have complete follow-up data completed at the First Affiliated Hospital of Shandong First Medical University. |
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| 2 Years |
| Intervertebral Disc Height Index (DHI) | Intervertebral Disc Height Index (DHI) | 2 Years |