ClinicalTrials.Veeva

Menu

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

S

Shenyang Orthopedic Hospital

Status

Unknown

Conditions

Intervertebral Disk Degeneration

Treatments

Device: K-rod dynamic stabilization system

Study type

Interventional

Funder types

Other

Identifiers

NCT03214042
ShenyangOrthoH-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

All

Ages

32 to 76 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

67 participants in 1 patient group

trial group
Experimental group
Description:
Sixty-seven patients with lumbar degenerative diseases were treated with K-rod dynamic stabilization system. All patients were followed for 2 years.
Treatment:
Device: K-rod dynamic stabilization system

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems