CompletedNot Applicable

Standardized Perioperative Care Protocol for Lumbar Fusion Surgery

China382 participantsStarted 2018-01-01

Plain-language 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.

Who can participate

Age range40 Years – 75 Years

SexALL

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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).

What they're measuring

Change in Oswestry Disability Index (ODI) Score

Timeframe: Baseline, 2 years

Trial details

NCT IDNCT07104448

SponsorHebei Medical University Third Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-01

View on ClinicalTrials.gov More Degenerative Lumbar Spondylolisthesis trials