NCT03214042

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

Efficacy and Safety of K-rod Dynamic Stabilization System in the Repair of Lumbar Degenerative Diseases: Study Protocol for a Prospective, Self-controlled, Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Shenyang Orthopedic Hospital · Academic / Other
• Sex: All
• Age: 32 Years – 76 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2017-08-01
• Completion: 2018-03-01
• First posted: 2017-07-11
• Last updated: 2018-02-12