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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
382
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.
Standard, non-protocolized institutional perioperative care, with management decisions based on the discretion of the attending surgeon and care team.
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
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.
Time frame: Baseline, 2 years
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.
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Baseline, 1 year, 2 years
Length of Hospital Stay (LOS)
The total number of days from admission to discharge for the index surgical procedure.
Time frame: 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.
Time frame: Up to 90 days post-surgery