Impact of a Standardized Perioperative Care Protocol on Functional and Radiographic Outcomes Following Transforaminal Lumbar Interbody Fusion for Degenerative Spondylolisthesis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Change in Oswestry Disability Index (ODI) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change in Oswestry Disability Index (ODI) Score
时间窗: 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.
次要结局
- Change in Japanese Orthopaedic Association (JOA) Score(Baseline, 3 months, 6 months, 1 year, 2 years)
- Change in Visual Analog Scale (VAS) for Back and Leg Pain(Baseline, 3 months, 6 months, 1 year, 2 years)
- Change in Short Form-36 (SF-36) Quality of Life Scores(Baseline, 3 months, 6 months, 1 year, 2 years)
- Radiographic Fusion Rate(1 year, 2 years)
- Change in Segmental Lordosis(Baseline, 1 year, 2 years)
- Change in Posterior Disc Height(Baseline, 1 year, 2 years)
- Length of Hospital Stay (LOS)(During hospital stay, up to approximately 14 days post-surgery)
- Incidence of Postoperative Complications(Up to 90 days post-surgery)
研究者
Baoli Li
Principal investigator
Hebei Medical University Third Hospital