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| ID | Type | Description | Link |
|---|---|---|---|
| CHGH-IRB-857-110-03 | Other Identifier | Cheng Hsin General Hospital Institutional Review Board |
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This observational study evaluates the clinical outcomes and procedural characteristics of navigation-assisted oblique lumbar interbody fusion (OLIF) in patients with lumbar degenerative disease. Between July 2021 and December 2021, adult patients undergoing OLIF with robotic or navigation assistance at Cheng Hsin General Hospital were included. Navigation systems were used to guide interbody cage placement and percutaneous pedicle screw insertion.
Information regarding operative time, intraoperative blood loss, radiation exposure to patients and operating room staff, and postoperative complications was collected. Clinical outcomes, including back and leg pain and lumbar function, were assessed during routine postoperative follow-up.
This study aims to describe the feasibility and short-term outcomes of navigation-assisted OLIF, including screw placement accuracy and early postoperative clinical improvement, and to provide additional clinical information regarding the use of navigation systems in minimally invasive lumbar fusion surgery.
This is a single-center observational study designed to assess procedural characteristics and short-term clinical outcomes associated with navigation-assisted oblique lumbar interbody fusion (OLIF) performed as part of routine clinical care.
Adult patients with lumbar degenerative disease who underwent OLIF with navigation assistance were included. Navigation systems were utilized to assist interbody cage placement and percutaneous pedicle screw insertion. No experimental interventions, randomization, or deviations from standard clinical practice were performed.
Collected data included operative time, estimated blood loss, radiation exposure related to navigation procedures, and perioperative complications. Clinical outcomes such as back and leg pain and lumbar function were evaluated during routine postoperative follow-up visits at 1 and 3 months after surgery.
The purpose of this study is to describe the feasibility and short-term performance of navigation-assisted OLIF and to contribute clinical data regarding the application of navigation systems in minimally invasive lumbar fusion procedures.
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of pedicle screw placement | Accuracy of pedicle screw placement assessed on postoperative computed tomography (CT) scans using the modified Gertzbein and Robbins classification. Screws were classified based on the degree of pedicle wall breach, and the proportion of accurately placed screws was calculated. | Postoperative period (3 months after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation exposure | Radiation exposure associated with navigation procedures, including cumulative radiation dose and exposure time during surgery. | During surgery |
| Postoperative complications |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult patients aged 20 years or older with lumbar degenerative disease who underwent oblique lumbar interbody fusion (OLIF) with navigation assistance as part of routine clinical care at a single tertiary medical center. All participants received surgical treatment based on standard clinical indications and provided written informed consent. Postoperative clinical and radiographic outcomes were evaluated during routine follow-up.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cheng Hsin General Hospital | Taipei | 112 | Taiwan |
individual participant data (IPD) will not be shared outside the study team. This is a single-center observational study, and all data were collected as part of routine clinical care. Data sharing is not planned due to patient privacy considerations and the absence of a pre-specified data sharing agreement in the study protocol and informed consent.
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Incidence of postoperative complications, including ileus, neurological deficits, and other surgery-related adverse events.
| Up to 3 months after surgery |
| Back pain intensity | Back pain intensity assessed using the Visual Analog Scale (VAS), where higher scores indicate greater pain severity. | Preoperative, 1 month, and 3 months after surgery |