Study on Topping-off Technique for Treating LDD

Official title

Study on Topping-off Technique for Treating Lumbar Degenerative Diseases

Overview

Lumbar degenerative disease is a common disease among middle-aged and elderly people as well as those who sit for a long time, mainly manifested as symptoms such as lower back pain, stiffness, and numbness in the lower limbs. Traditional surgical treatments such as lumbar fusion can alleviate symptoms, but may lead to complications such as adjacent segment degeneration. Therefore, exploring safer and more effective treatment methods is of great significance. Topping off technique, as a new treatment method, combines the advantages of interbody fusion and dynamic fixation, aiming to reduce the pressure on the intervertebral disc at the surgical site, promote the repair of diseased intervertebral discs, while preserving partial mobility of the lumbar spine.The aim of this study is to evaluate the clinical efficacy and imaging changes of Topping off technique in the treatment of lumbar degenerative diseases. The Topping off technique combines posterior lumbar interbody fusion (PLIF) and Wallis interspinous dynamic fixation device implantation. Through prospective clinical trials, its therapeutic effect on patients with continuous double segment lumbar degenerative diseases was observed. The study included patients who underwent surgery for degenerative lumbar diseases in L4-5 and L5-S1, who were treated with two-stage fusion surgery and Topping off technique, respectively. Follow up was conducted before and after surgery, with an average follow-up time of 24 months. Evaluate preoperative and postoperative efficacy using Oswestry Disability Index (ODI), Pain Visual Analog Scale (VAS), and Japanese Orthopaedic Association (JOA) lumbar spine function score, and calculate recovery rate. At the same time, X-ray and MRI images were used to detect the overall range of motion (L2\~S1ROM) of the lumbar spine, the range of motion (ROM) of the Wallis device inserted segments, the intervertebral disc height index (DHI), and the relative signal intensity of the nucleus pulposus (RSI) of the intervertebral disc.

Detailed description

The aim of this study is to evaluate the clinical efficacy and imaging changes of Topping off technique in the treatment of lumbar degenerative diseases. The Topping off technique combines posterior lumbar interbody fusion (PLIF) and Wallis interspinous dynamic fixation device implantation. Through prospective clinical trials, its therapeutic effect on patients with continuous double segment lumbar degenerative diseases was observed. The study included patients who underwent surgery for degenerative lumbar diseases in L4-5 and L5-S1, who were treated with two-stage fusion surgery and Topping off technique, respectively. Follow up was conducted before and after surgery, with an average follow-up time of 24 months. Evaluate preoperative and postoperative efficacy using Oswestry Disability Index (ODI), Pain Visual Analog Scale (VAS), and Japanese Orthopaedic Association (JOA) lumbar spine function score, and calculate recovery rate. At the same time, X-ray and MRI images were used to detect the overall range of motion (L2\~S1ROM) of the lumbar spine, the range of motion (ROM) of the Wallis device inserted segments, the intervertebral disc height index (DHI), and the relative signal intensity of the nucleus pulposus (RSI) of the intervertebral disc.

Interventions

• Procedure Topping-off Group
  Topping-off group Patients who have undergone the Topping-off system insertion surgery for lumbar spondylosis and have complete follow-up data and meet the standards completed at the First Affiliated Hospital of Shandong First Medical University. Fusion group Patients who have undergone lumbar spine fusion surgery due to lumbar spondylosis and meet the standards and have complete follow-up data completed at the First Affiliated Hospital of Shandong First Medical University.
• Procedure Fusion Group
  Topping-off group Patients who have undergone the Topping-off system insertion surgery for lumbar spondylosis and have complete follow-up data and meet the standards completed at the First Affiliated Hospital of Shandong First Medical University. Fusion group Patients who have undergone lumbar spine fusion surgery due to lumbar spondylosis and meet the standards and have complete follow-up data completed at the First Affiliated Hospital of Shandong First Medical University.

Primary outcome measures

• VAS [Time frame: 2 Years]
• JOA [Time frame: 2 Years]
• Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position [Time frame: 2 Years]

Secondary outcome measures (3)

• Lumbar spine overall range of motion (L2~S1ROM) [Time frame: 2 Years]
• Wallis device insertion segment mobility (ROM) [Time frame: 2 Years]
• Intervertebral Disc Height Index (DHI) [Time frame: 2 Years]

Eligibility criteria

Inclusion criteria

• The patient's clinical manifestations, physical examination, and imaging data all support the diagnosis of degenerative lumbar spondylosis.
• Those who have undergone strict and formal conservative treatment for at least 3 months before surgery and have no significant improvement in symptoms.
• Preoperative imaging examination showed L4-5 and L5-S1 responsible segment protrusion or protrusion leading to segment stenosis.
• Surgeries are performed by the same chief surgeon.

Exclusion criteria

• Lumbar instability, lumbar spondylolisthesis above grade II.
• Patients with severe osteoporosis, tuberculosis, or tumors.
• Systemic diseases that affect surgical treatment and medication, such as heart disease, liver disease, and kidney disease.
• Patients with mental illness, poor compliance, and inability to cooperate in completing follow-up.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Shandong First Medical University — Jinan

Identifiers

NCT: NCT06650046 · Topping-off Technique

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗