Degenerative Lumbar SpondylolisthesisNCT07104448
Standardized Perioperative Care Protocol for Lumbar Fusion Surgery
A study testing Standardized Perioperative Care Protocol and Conventional care in people with Degenerative Lumbar Spondylolisthesis, run by Hebei Medical University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Degenerative Lumbar Spondylolisthesis
- What is being tested?
- Standardized Perioperative Care Protocol and Conventional care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Being tested
- Standardized Perioperative Care Protocol, Conventional care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Perioperative Care ProtocolBehavioural
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 careOther
Standard, non-protocolized institutional perioperative care, with management decisions based on the discretion of the attending surgeon and care team.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 years
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 year, 2 years
Length of Hospital Stay (LOS)
The total number of days from admission to discharge for the index surgical procedure.
Measured: 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.
Measured: Up to 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Jan 2018
- Primary completion1 Jun 2023
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Lumbar SpondylolisthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baoli Li, Hebei Medical University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104448
- Sponsor's protocol ID
- KE2017-011-1
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41488876
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07104448
- Acronym / sponsor ID
- KE2017-011-1
- Conditions
- Degenerative Lumbar Spondylolisthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Standardized Perioperative Care Protocol (SPCP) Group | Experimental | Behavioral: Standardized Perioperative Care ProtocolPatients 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. |
| Active Comparator: Conventional Care Group | Active comparator | Other: Conventional carePatients 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Perioperative Care ProtocolA 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. | Behavioural | Experimental: Standardized Perioperative Care Protocol (SPCP) Group |
| Conventional careStandard, non-protocolized institutional perioperative care, with management decisions based on the discretion of the attending surgeon and care team. | Other | Active Comparator: Conventional Care Group |
Primary outcome
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.
8 secondary outcomes
Change in Japanese Orthopaedic Association (JOA) Score
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Visual Analog Scale (VAS) for Back and Leg Pain
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Change in Short Form-36 (SF-36) Quality of Life Scores
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years
Radiographic Fusion Rate
Time frame: 1 year, 2 years
Change in Segmental Lordosis
Time frame: Baseline, 1 year, 2 years
Change in Posterior Disc Height
Time frame: Baseline, 1 year, 2 years
Length of Hospital Stay (LOS)
Time frame: During hospital stay, up to approximately 14 days post-surgery
Incidence of Postoperative Complications
Time frame: Up to 90 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Derived from this study: PubMed 41488876Zhao 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.
Related trials for Degenerative Lumbar Spondylolisthesis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Degenerative Disc Disease, Spondylolisthesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Perioperative Care Protocol and Conventional care in people with Degenerative Lumbar Spondylolisthesis, run by Hebei Medical University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (ODI) Score (time frame: Baseline, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07104448, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.