An interventional study of Standardized Perioperative Care Protocol and Conventional care in Degenerative Lumbar Spondylolisthesis, sponsored by Hebei Medical University Third Hospital. Completed at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by Hebei Medical University Third Hospital · Not applicable, Interventional, and Treatment
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.
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.
227 studies on the registry are indexed under Spondylolisthesis; 43 are open to participants now.
This study's enrollment of 382 is above the median of 60 across 143 interventional studies indexed under Spondylolisthesis.
Browse Spondylolisthesis studies →Hebei Medical University Third Hospital is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Standard, non-protocolized institutional perioperative care, with management decisions based on the discretion of the attending surgeon and care team.
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.
Time frame: Baseline, 2 years
Change in Japanese Orthopaedic Association (JOA) Score
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.
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Visual Analog Scale (VAS) for Back and Leg Pain
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.
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Short Form-36 (SF-36) Quality of Life Scores
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.
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Radiographic Fusion Rate
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.
Time frame: 1 year, 2 years
Change in Segmental Lordosis
Change from baseline in the segmental lordosis angle at the index surgical level, measured on standing lateral X-rays.
Time frame: Baseline, 1 year, 2 years
Change in Posterior Disc Height
Change from baseline in the posterior disc height at the index surgical level, measured on standing lateral X-rays.
Time frame: Baseline, 1 year, 2 years
Length of Hospital Stay (LOS)
The total number of days from admission to discharge for the index surgical procedure.
Time frame: During hospital stay, up to approximately 14 days post-surgery
Incidence of Postoperative Complications
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.
Time frame: Up to 90 days post-surgery
Ran from Jan 2018 to primary completion in Jun 2023, 65 months.
Of 42 non-industry interventional studies with no phase under Spondylolisthesis, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 63. This study's 65 months is above that.
Counting every sponsor, half of 61 studies reached it within 46 months; a quarter within 16 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Hebei Medical University Third Hospital