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This is a prospective, randomized controlled trial to evaluate whether a comprehensive, standardized perioperative care protocol (SPCP) improves functional recovery, radiographic outcomes, and quality of life compared to conventional care in patients undergoing transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar spondylolisthesis. The study aims to demonstrate that a protocol-driven approach can lead to better patient outcomes and increased healthcare efficiency.
Transforaminal lumbar interbody fusion (TLIF) is a common surgical treatment for degenerative lumbar spondylolisthesis, but patient outcomes can be variable due to inconsistencies in perioperative management. Enhanced Recovery After Surgery (ERAS) principles have shown promise, but their comprehensive application in spine surgery requires further validation. This study hypothesizes that a multifaceted Standardized Perioperative Care Protocol (SPCP), which integrates preoperative optimization (education, nutrition), standardized intraoperative techniques, and a structured, goal-directed postoperative rehabilitation plan, will result in superior outcomes compared to conventional, non-protocolized care. A total of 382 patients were randomized to either the SPCP or conventional care group. The study will assess outcomes at multiple time points up to 2 years post-surgery to determine the long-term efficacy of the protocol in improving functional recovery, spinal fusion, quality of life, and reducing complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Standardized Perioperative Care Protocol (SPCP) Group | Experimental | Patients randomized to this group received a multi-modal, standardized protocol that included: comprehensive preoperative education and optimization; standardized intraoperative anesthesia and surgical techniques; and a structured postoperative rehabilitation program featuring multimodal analgesia and goal-directed early mobilization. |
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| Active Comparator: Conventional Care Group | Active Comparator | Patients randomized to this group received standard institutional care, which was not protocolized. This typically involved surgeon-preference-based perioperative management, variable timing for mobilization and catheter removal, and discharge based on the attending surgeon's general assessment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Perioperative Care Protocol | Behavioral | A multi-component protocol involving preoperative patient education, nutritional screening, standardized anesthesia, goal-directed fluid therapy, multimodal opioid-sparing analgesia, and a structured physiotherapy-led mobilization schedule starting on postoperative day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oswestry Disability Index (ODI) Score | The change in the ODI score from baseline to 2 years post-surgery. The ODI (version 2.1a) is a patient-reported outcome measure that assesses disability due to low back pain. Scores range from 0 to 100, with lower scores indicating less disability. | Baseline, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Japanese Orthopaedic Association (JOA) Score | Change from baseline in the JOA score, which evaluates clinical symptoms, function, and activities of daily living for patients with lumbar disease. Scores range from 0-29, with higher scores indicating better function. | Baseline, 3 months, 6 months, 1 year, 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41488876 | Derived | Zhao Y, Wu J, Zhang Z, Wang Y, Li B. Impact of a standardized perioperative care protocol on functional and radiographic outcomes following transforaminal lumbar interbody fusion for degenerative spondylolisthesis: a 2-year randomized controlled trial. Front Surg. 2025 Dec 18;12:1679851. doi: 10.3389/fsurg.2025.1679851. eCollection 2025. |
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| Conventional care | Other | Standard, non-protocolized institutional perioperative care, with management decisions based on the discretion of the attending surgeon and care team. |
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| Change in Visual Analog Scale (VAS) for Back and Leg Pain |
Change from baseline in patient-reported back and leg pain, measured on a 0-10 scale, where 0 represents no pain and 10 represents the worst imaginable pain. |
| Baseline, 3 months, 6 months, 1 year, 2 years |
| Change in Short Form-36 (SF-36) Quality of Life Scores | Change from baseline in the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the SF-36 survey, which measures health-related quality of life. | Baseline, 3 months, 6 months, 1 year, 2 years |
| Radiographic Fusion Rate | The proportion of patients achieving solid fusion (Bridwell classification Grade I or II) at the index surgical level, as assessed by standing lateral X-rays. | 1 year, 2 years |
| Change in Segmental Lordosis | Change from baseline in the segmental lordosis angle at the index surgical level, measured on standing lateral X-rays. | Baseline, 1 year, 2 years |
| Change in Posterior Disc Height | Change from baseline in the posterior disc height at the index surgical level, measured on standing lateral X-rays. | Baseline, 1 year, 2 years |
| Length of Hospital Stay (LOS) | The total number of days from admission to discharge for the index surgical procedure. | During hospital stay, up to approximately 14 days post-surgery |
| Incidence of Postoperative Complications | The number and proportion of patients experiencing any adverse events within 90 days of surgery, including but not limited to surgical site infection, dural tear, DVT, ileus, and urinary retention. | Up to 90 days post-surgery |