Intervertebral Disk Degeneration Clinical Trial
Official title:
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
Verified date | February 2018 |
Source | Shenyang Orthopedic Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shenyang Orthopedic Hospital |
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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