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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03214042
Other study ID # ShenyangOrthoH-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received July 9, 2017
Last updated February 8, 2018
Start date March 1, 2013
Est. completion date March 2018

Study information

Verified date February 2018
Source Shenyang Orthopedic Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 67
Est. completion date March 2018
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 32 Years to 76 Years
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shenyang Orthopedic Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Oswestry dysfunction index scores To quantify disability for pain. The Oswestry Disability Index questionnaire contains ten questions concerning intensity of pain, ability to take care of oneself, lifting, ability to walk, ability to sit, ability to stand, sleep quality, sexual life, social life, and ability to travel. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. at month 24 after surgery
Secondary Lumbar lordosis angle The lumbar lordosis angle refers to an angle between the lower end plate of L1 and the upper end plate of S1 on the lateral X-ray. at month 24 after surgery
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Completed NCT00310440 - An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation N/A
Terminated NCT02070484 - Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease N/A
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