Skip to main content
OpenTrials
Completed

NCT Number: NCT07104448

Standardized Perioperative Care Protocol for Lumbar Fusion Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Degenerative Lumbar Spondylolisthesis

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Conventional care

Other

Standard, non-protocolized institutional perioperative care, with management decisions based on the discretion of the attending surgeon and care team.

Primary outcomes

  1. Change in Oswestry Disability Index (ODI) Score

    Time frame: 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 outcomes

  1. Change in Japanese Orthopaedic Association (JOA) Score

    Time frame: 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.

  2. Change in Visual Analog Scale (VAS) for Back and Leg Pain

    Time frame: 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.

  3. Change in Short Form-36 (SF-36) Quality of Life Scores

    Time frame: 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.

  4. Radiographic Fusion Rate

    Time frame: 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.

  5. Change in Segmental Lordosis

    Time frame: Baseline, 1 year, 2 years

    Change from baseline in the segmental lordosis angle at the index surgical level, measured on standing lateral X-rays.

  6. Change in Posterior Disc Height

    Time frame: Baseline, 1 year, 2 years

    Change from baseline in the posterior disc height at the index surgical level, measured on standing lateral X-rays.

  7. Length of Hospital Stay (LOS)

    Time frame: During hospital stay, up to approximately 14 days post-surgery

    The total number of days from admission to discharge for the index surgical procedure.

  8. Incidence of Postoperative Complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hebei Medical University Third Hospital

Other

Registry information

Official study title

Impact of a Standardized Perioperative Care Protocol on Functional and Radiographic Outcomes Following Transforaminal Lumbar Interbody Fusion for Degenerative Spondylolisthesis: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2023
Study completion
2025
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.