The Study of INTRA Spine Non Fusion Technique in the Treatment of Lumbar Degenerative Disease

NCT06075966 | Enrolling By Invitation DMC

• 1 other identifier: INTRA Spine
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Lumbar degenerative diseases such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSSS) are common and frequently encountered in orthopaedics. With the acceleration of the aging process of society, their incidence rate increases year by year. At present, conservative treatment is the preferred choice for this type of disease, and surgical treatment is feasible in cases where conservative treatment is ineffective. The main surgical methods include simple laminectomy and nucleus pulposus removal, intervertebral fusion and internal fixation, intervertebral disc replacement, and non fusion surgery. Simple nucleus pulposus removal surgery has drawbacks such as loss of intervertebral height and foramen height, which can affect spinal stability; Intervertebral fusion and internal fixation surgery has the problem of accelerating adjacent segment degeneration; The current therapeutic effect of lumbar disc replacement is not yet clear, and the technology is not yet mature. In response to the shortcomings of the above surgical methods, the advancement of science and technology has driven the development of spinal surgery, and a new surgical concept has emerged - spinal non fusion fixation technology. The INTRA-Spine dynamic stability system between vertebral lamina is one of the non fusion technologies of the spine. The core concept of this technology is to provide dynamic fixation on the basis of sufficient decompression of nerves, with the rotation center located between the vertebral lamina, which is closer to the normal movement center of the lumbar spine. It simulates the normal physiological structure of the lumbar spine with minimal damage and trauma, and maximizes the preservation of surgical segment mobility while maintaining spinal stability, Reducing stress concentration in adjacent segments caused by local fusion, thereby reducing the acceleration of adjacent segment degeneration, theoretically has good clinical and imaging efficacy.

Conditions

Lumbar Degenerative Disease

Keywords

INTRA Spine system; dynamic stabilization; non-fusion; Lumbar degeneration; Lumbar range of motion

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 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.

  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)

• ROM,range of motion

  2 Years

• posterior disc height, PDH

  2 years

• foraminal height ,FH

  2 years

Study Arms (2)

Non-fusion group

EXPERIMENTAL

Patients who have undergone the INTRA-Spine dynamic stabilization 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.

Other: Non-fusion group; Other: 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.

Other: Non-fusion group; Other: Fusion group

Interventions

Non-fusion group OTHER

Patients who have undergone the INTRA-Spine dynamic stabilization 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; Non-fusion group

Fusion group OTHER

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; Non-fusion 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 single 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 (2)

Hao-Xuan Zhang

Jinan, Shandong, 250000, China

Location

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

Location

Study Officials

• Hao-Xuan Zhang, Ph.D/MD

  Shandong First Medical University

  STUDY CHAIR

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: September 16, 2023
• First Posted: October 10, 2023
• Study Start: January 1, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)