Degenerative Lumbar Spondylolisthesis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStandardized Perioperative Care Protocol
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.
OTHERConventional care
Standard, non-protocolized institutional perioperative care, with management decisions based on the discretion of the attending surgeon and care team.
Sponsors
Hebei Medical University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic, single-level (L3-L4, L4-L5, or L5-S1) degenerative spondylolisthesis (Meyerding Grade I or II). * Failure of at least 6 months of conservative therapy. * Age between 40 and 75 years. * Suitable for and scheduled to undergo transforaminal lumbar interbody fusion (TLIF) surgery. * Provided written informed consent.
Exclusion criteria
* High-grade spondylolisthesis (Grade \> II). * History of previous lumbar surgery. * Presence of active spinal infection, tumor, or trauma. * Severe osteoporosis (T-score \< -3.0). * Significant medical comorbidities precluding major surgery (ASA physical status \> III).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oswestry Disability Index (ODI) Score | Baseline, 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Fusion Rate | 1 year, 2 years | 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. |
| Change in Japanese Orthopaedic Association (JOA) Score | Baseline, 3 months, 6 months, 1 year, 2 years | 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. |
| Change in Visual Analog Scale (VAS) for Back and Leg Pain | Baseline, 3 months, 6 months, 1 year, 2 years | 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. |
| Change in Segmental Lordosis | Baseline, 1 year, 2 years | Change from baseline in the segmental lordosis angle at the index surgical level, measured on standing lateral X-rays. |
| Change in Posterior Disc Height | Baseline, 1 year, 2 years | Change from baseline in the posterior disc height at the index surgical level, measured on standing lateral X-rays. |
| Length of Hospital Stay (LOS) | During hospital stay, up to approximately 14 days post-surgery | The total number of days from admission to discharge for the index surgical procedure. |
| Incidence of Postoperative Complications | Up to 90 days post-surgery | 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. |
| Change in Short Form-36 (SF-36) Quality of Life Scores | Baseline, 3 months, 6 months, 1 year, 2 years | 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. |
Countries
China
Outcome results
None listed