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| Name | Class |
|---|---|
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
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Laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases. It removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression, and then utilizes a spinal fixation system to stabilize the structure to relieve lower limb pain, paralysis, and other symptoms. However, the spinal cord that lacks lamina coverage after surgery is often compressed by scar tissue formation and hematoma, leading to postoperative back and lower limb pain. Therefore, this trial is divided into two groups, comparing the use of the cross connector of the ORION spinal system - the spinal lamina cover and the general spinal fixation system (without lamina cover). For participants undergoing laminectomy with internal fixation and osseofusion, after utilizing the spinal lamina cover of the ORION spinal system, whether the nerve compression caused by postoperative scar tissue formation and hematoma can be effectively reduced, and the pain in the back and lower limbs can be improved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | General spinal system |
|
| LMC group | Experimental | General spinal system with ORION spinal lamina cover |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham | Device | Sham |
| |
| ORION spinal lamina cover |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | To observe the recovery of the participants' spine | Six months after surgery |
| Visual Analogue Scale (VAS) | To measure the pain and numb of the participants' back and limbs | Pre-surgery; one month after surgery; three months after surgery; six months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) | To evaluate the functional disability of the participants' limbs | Pre-surgery; one month after surgery; three months after surgery; six months after surgery |
| Sort Form-12 Health Survey (SF-12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu-Cheng Yao | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan |
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| Device |
an artificial lamina coverage of the ORION spinal system |
|
To evaluate the physical health of the participants
| Pre-surgery; one month after surgery; three months after surgery; six months after surgery |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D012600 | Scoliosis |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013121 | Spinal Curvatures |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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