Study on Topping-off Technique for Treating LDD

NCT06650046 | Recruiting DMC

• 1 other identifier: Topping-off Technique
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Degenerative Disease

Keywords

Topping-off technique

Outcome Measures

Primary Outcomes (3)

• VAS

  The visual analog scale (VAS) is used for pain assessment. It is widely used in clinical practice in China, and the basic method is to use a vernier ruler with a length of about 10cm, marked with 10 scales on one side, with both ends \- Page 3 of 5 \[DRAFT\] - The visual analog scale (VAS) is used for pain assessment. It is widely used in clinical practice in China, and the basic method is to use a vernier ruler with a length of about 10cm, marked with 10 scales on one side, with both ends marked as "0" and "10" respectively. A score of 0 indicates painlessness, and a score of 10 represents the most severe pain that cannot be tolerated. pain that cannot be tolerated.

  2 Years

• JOA

  The Japanese Orthopaedic Association Scores (JOA) is a neurological function scoring system recommended by the Japanese Orthopaedic Association, which includes four parts: upper limb motor function, lower limb motor function, sensory and bladder function, with a total score of 29 points. The lower the score, the more severe the neurological dysfunction.

  2 Years

• Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position

  Cobb angle of surgical space and adjacent space in neutral position, over extension and over flexion position

  2 Years

Secondary Outcomes (3)

• Lumbar spine overall range of motion (L2~S1ROM)

  2 Years

• Wallis device insertion segment mobility (ROM)

  2 Years

• Intervertebral Disc Height Index (DHI)

  2 Years

Study Arms (2)

Topping-off group

EXPERIMENTAL

Topping-off group Patients who have undergone the Topping-off 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.

Procedure: Topping-off Group; Procedure: Fusion Group

Fusion group

ACTIVE COMPARATOR

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: Topping-off Group; Procedure: Fusion Group

Interventions

Topping-off Group PROCEDURE

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.

Fusion group; Topping-off group

Fusion Group PROCEDURE

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.

Fusion group; Topping-off group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

RECRUITING

Study Officials

• Hao-Xuan Zhang, Ph.D/MD

  Shandong First Medical University

  STUDY CHAIR

Central Study Contacts

Hao-Xuan Zhang, Ph.D/MD

CONTACT

CN+86+15275105665; hoho0605@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 21, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)