Standardized Perioperative Care Protocol for Lumbar Fusion Surgery

NCT07104448 | Completed

• 1 other identifier: KE2017-011-1
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Lumbar Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

Study Arms (2)

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.

Behavioral: Standardized Perioperative Care Protocol

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.

Other: Conventional care

Interventions

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.

Experimental: Standardized Perioperative Care Protocol (SPCP) Group

Conventional care OTHER

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

Active Comparator: Conventional Care Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

Study Sites (1)

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Related Publications (1)

• 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.

  PMID: 41488876 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: January 1, 2018
• Primary Completion: June 1, 2023
• Study Completion: May 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

CN (1)