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TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral fixation | Experimental | Patients undergoing TLIF and unilateral pedicle screw fixation |
|
| Bilateral fixation | Active Comparator | Patients undergoing TLIF and bilateral pedicle screw fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLIF and unilateral pedicle screw fixation | Procedure | TLIF combined with posterior unilateral pedicle screw fixation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) scores | 2 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events related to procedure | 2 years postoperatively | |
| Operative duration | 1 week postoperatively | |
| Estimated blood loss |
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Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedic Surgery, Shanghai Ninth People's Hospital | Shanghai | 200011 | China |
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| ID | Term |
|---|---|
| D065289 | Pedicle Screws |
| ID | Term |
|---|---|
| D001863 | Bone Screws |
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| TLIF and bilateral pedicle screw fixation | Procedure | TLIF combined with posterior bilateral pedicle screw fixation |
|
| Pedicle screw and cage | Device | Pedicle screw and cage |
|
| 1 week postoperatively |
| Length of hospital stay | 1 week after discharge |
| Spinal angles | Radiographic parameters | 2 years postoperatively |
| Intervertebral space height | Radiographic parameters | 2 years postoperatively |
| Foraminal height | Radiographic parameters | 2 years postoperatively |
| Cost of treatment | 2 years postoperatively |
| Fusion rate | 2 years postoperatively |
| Oswestry Disability Index (ODI) | 2 years postoperatively |
| D009984 |
| Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |