Efficacy and Safety of K-rod Dynamic Stabilization System in the Repair of Lumbar Degenerative Diseases

NCT ID: NCT03214042

Last Updated: 2018-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-01
• Study Completion Date: 2018-03-31

Brief Summary

To conduct a prospective, single-center, self-controlled, clinical trial to verify the efficacy and safety of K-Rod dynamic stability system in the repair of lumbar degenerative diseases following 2 years follow-up, aiming to provide references for clinical treatment of lumbar degenerative diseases.

Detailed Description

Posterior internal fixation and fusion systems are still one of the main methods for the treatment of chronic back pain due to intervertebral disc degeneration, but adverse reactions, such as accelerated regression of adjacent segments, are often inevitable during the treatment.

At present, various pedicle screw-based posterior dynamic stability systems of the lumbar spine have become an alternative fusion therapy for lumbar degenerative diseases. Dynamic stability is defined to reduce the loading on the intervertebral disc/articular surfaces, to maintain movement under mechanical load, to limit the abnormal movement of the spinal segment, and to reduce the stress on the bone-screw interface dynamically and stably. An ideal fixation system will be stable enough to maximize the fusion rate without the need for excessive rigidity, as well as to maintain maximum load and physiological posture of the vertebral segment, thereby reducing the horizontal stress of the adjacent segment.

Conditions

Intervertebral Disk Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

trial group

Sixty-seven patients with lumbar degenerative diseases were treated with K-rod dynamic stabilization system. All patients were followed for 2 years.

Group Type: EXPERIMENTAL

K-rod dynamic stabilization system

Intervention Type: DEVICE

Sixty-seven patients with lumbar degenerative diseases were treated with K-rod dynamic stabilization system. All patients were followed for 2 years. K-rod dynamic stabilization system was purchased from Biotech, USA, consisting of titanium alloy pedicle screw, titanium alloy line and polyether ether ketone (PEEK) shell between pedicle screw heads.

Interventions

K-rod dynamic stabilization system

Sixty-seven patients with lumbar degenerative diseases were treated with K-rod dynamic stabilization system. All patients were followed for 2 years. K-rod dynamic stabilization system was purchased from Biotech, USA, consisting of titanium alloy pedicle screw, titanium alloy line and polyether ether ketone (PEEK) shell between pedicle screw heads.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Degenerative lumbar spondylolisthesis (degree I)
• Nerve root canal or central spinal canal stenosis
• Accompanying nerve root pain and/or chronic back pain
• 32-76 years old
• Regardless of gender
• All patients or family members signed the informed consent

Exclusion Criteria

• Systemic infection;
• Poor compliance and inability to complete the trial

• Minimum Eligible Age: 32 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Orthopedic Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shuyi Gong

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuyi Gong

Role: PRINCIPAL_INVESTIGATOR

Shenyang Orthopedic Hospital

Other Identifiers

ShenyangOrthoH-01

Identifier Type: -

Identifier Source: org_study_id