Comparison Of A Novel Hand-held Retractor-Assisted Transforaminal Lumbar Interbody Fusion By The Wiltse Approach And Posterior TLIF
Condition: Lumbar Stenosis; Spondylolisthesis
MeSH terms: Spondylolisthesis
Study type: Interventional

Summary: 
      In recent years, hand-held retractors have been applied to assist in Wiltse approach to
      perform canal decompression, causing less paraspinal muscle injury and yielding better
      postoperative clinical outcomes than P-TLIF. However, few prospective studies have been
      conducted comparing the clinical and radiological outcomes between Wiltse TLIF and P-TLIF,
      both assisted by hand-held retractors. Therefore, further research is warranted to assess
      whether hand-held retractor-assisted Wiltse TLIF can yield less paraspinal muscle injury and
      better postoperative clinical outcomes.
    

Detailed description: 
      Study procedures How many people will participate in this study? Approximately 60 people will
      participate in this study conducted at the Nanfang Hospital of Southern Medical University.

      Research Steps ■ Pre-study:

      To determine if you are eligible to participate, the following procedures will be conducted
      during the screening:

      Obtain your demographic and vital sign information Perform a physical examination Inquire
      about your medical history and concurrent medications Collect blood and urine samples for
      laboratory testing, imaging (X-ray, CT, MRI) If you are a fertile female, a pregnancy test
      will be conducted. A negative result is required for your participation in this study.

      The screening results and/or results of relevant issues will help the researchers decide if
      you can continue with this study. If these checks indicate that you are suitable for this
      study, you will be informed by the researchers to proceed to visit 2 as soon as possible. If
      you do not meet the relevant criteria, you cannot continue to participate in this study, and
      the results will be communicated to you promptly.

      ■ Baseline Phase

      If the researchers confirm that you meet the criteria for joining this trial, you will be
      enrolled in this study and undergo a transforaminal lumbar interbody fusion (TLIF) through
      either a multilevel paraspinal approach or a posterior midline approach, which will be
      randomly allocated (similar to drawing lots). The following procedures will be conducted
      during this visit:

      Reconfirm your eligibility for participation Allocate you to either the multilevel paraspinal
      group or the posterior midline group based on randomization Conduct a physical examination
      and collect vital sign data Preoperative visual analog scale (VAS) score for pain, Oswestry
      Disability Index (ODI) score for back pain, Japanese Orthopaedic Association (JOA) score for
      lower back pain, and MOS 36-Item Short Form Health Survey (SF-36) quality of life score ■
      Treatment Phase

      During this period, the researchers will perform surgery on you based on the randomization
      results and assess the surgical outcomes. To ensure the accurate recording and evaluation of
      your condition, your cooperation is required for the following procedures:

      Record postoperative drainage, time to get out of bed, discharge time, and postoperative
      complications Extract approximately 5ml of venous blood from you 24 hours after surgery to
      measure serum creatine kinase (CK) and C-reactive protein (CRP) Assess you using the VAS,
      ODI, JOA lower back pain score, and SF-36 quality of life score 7 days after surgery

      ■ Follow-up Phase

      After you complete this stage of visits, it is generally considered that you have completed
      the entire study. The following procedures will be carried out during this period:

      X-ray examination of the lumbar vertebrae in the anteroposterior and lateral views,
      assessment of pain, functional impairment, and quality of life score at the 3rd month after
      surgery X-ray and lumbar spine MRI at the 6th month after surgery, assessment of pain,
      functional impairment, and quality of life score X-ray and lumbar spine CT at the 1st year
      after surgery, assessment of pain, functional impairment, and quality of life score X-ray and
      lumbar spine CT at the 2nd year after surgery, assessment of pain, functional impairment, and
      quality of life score 3.3. What tests and assessments will be conducted in this study? After
      providing written informed consent, you will undergo various tests, examinations, and
      procedures during this study. If you have any concerns about any of these tests, please
      discuss them with the study doctor.

      Regarding the tests and procedures for this study, we would like to provide the following
      information:

      Medical history: The study doctor will ask you some questions to understand any current or
      past illnesses.

      Demographic data: The study doctor will collect personal information about you, such as date
      of birth and ethnic background.

      Physical examination: The study doctor will conduct a medical examination of your body to
      assess all or part of the following human body systems: head, eyes, ears, nose and throat,
      chest, lungs, heart, abdomen, bones, skin, neck, and nervous system.

      Height and weight: Your height and weight will be measured. Vital signs: The study doctor
      will measure your blood pressure, heart rate, body temperature, and respiratory rate.

      Blood collection: During this study, you will undergo multiple blood draws. Blood samples
      will be collected for the following purposes:

      Preoperative blood draw: Preoperative tests (complete blood count, electrolytes, liver and
      kidney function, coagulation function, infection indicators), routine preoperative
      assessment.

      Blood draw 24 hours after surgery: Approximately 5ml of venous blood will be drawn to measure
      serum creatine kinase (CK) and C-reactive protein (CRP).

      Routine blood tests on the 3rd day after surgery: Complete blood count, ion six tests,
      infection two tests.

      Urine samples: Routine urine tests. Pulmonary function and echocardiography if necessary.
      Lumbar spine anteroposterior (preoperative, 7 days after surgery, 3 months after surgery, 6
      months after surgery, 1 year after surgery, 2 years after surgery), dynamic positions,
      oblique positions, lumbar spine MRI (preoperative and 6 months after surgery), lumbar spine
      CT (preoperative, 1 year after surgery, 2 years after surgery).

      Questionnaire: Visual Analog Scale (VAS) score for pain, Oswestry Disability Index (ODI)
      score for back pain, Japanese Orthopaedic Association (JOA) score for lower back pain, and
      MOS 36-Item Short Form Health Survey (SF-36) quality of life score (preoperative, 7 days
      after surgery, 3 months after surgery, 6 months after surgery, 1 year after surgery, 2 years
      after surgery) How long will this study last? This clinical study will last approximately 2
      years (6 visits in total). During your participation in this study, you must comply with the
      specified visit schedule.

      You have the right to control the use and disclosure of your personal information. Where
      permitted by national law, you can request to view your medical information at any time. You
      have the right to review all information collected about you in this study and request
      corrections (if applicable).

      New information related to the study During the study period, if there are changes in study
      procedures, newly discovered side effects, or significant developments that may affect your
      health or willingness to participate, the research team will inform you. The study doctor
      will notify you immediately and discuss with you whether you want to continue participating
      in this study. If you decide not to continue in this study, the study doctor will make
      arrangements for your diagnostic and therapeutic care to continue. If you choose to remain in
      this study, the study doctor may ask you to sign a new informed consent form.

      Use of Research Results and Confidentiality of Personal Information At the end of the study,
      we will prepare a report and send it to the government regulatory agency. The results of this
      study may also be published in journals or presented at conferences, but will not contain any
      information that could identify you. To ensure privacy, records or samples published for
      research purposes will not include your name or other identifying information. Instead, your
      information will be identified only by a code. Only the study doctor and authorized personnel
      will be able to link this code to your name using a list that will be securely kept at the
      study center. In order to ensure that the study is conducted correctly at the study center,
      when necessary, the applicant, the ethics review committee, and the government regulatory
      authorities may review your information according to regulations. They are bound by
      confidentiality and will not violate your privacy.

      You have the right to control the use and disclosure of your personal information. Where
      permitted by national law, you can request to view your medical information. You have the
      right to review all information collected about you in this study and request corrections (if
      applicable).
    

Intervention name(s): new hand-held retractor systems-assisted WiltseTLIF surgery
Intervention type(s): Procedure
Intervention description(s): patients were included in study group underwent the new hand-held retractors assisted Wiltse TLIF surgery
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This one-year prospective controlled study compared two approaches (Wiltse TLIF vs P-TLIF) for hand-held retractors-assisted TLIF was approved by the Institutional Review Board (IRB) of our hospital. Written informed consent was obtained from all study participants. 60 eligible patients were included in this study and were divided into two groups.30patientswere included in the study group and underwent Wiltse TLIF, and 30 were included in the control group and underwent P-TLIF.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wiltse approach TLIF; transforaminal lumbar interbody fusion; hand-held retractors system