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

NCT03214042 | Unknown DMC

• 1 other identifier: ShenyangOrthoH-01
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intervertebral Disk Degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lumbar lordosis angle

  at month 24 after surgery

Study Arms (1)

trial group

EXPERIMENTAL

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

Device: K-rod dynamic stabilization system

Interventions

K-rod dynamic stabilization system 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.

trial group

Eligibility Criteria

• Age: 32 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shenyang Orthopedic Hospital: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Shuyi Gong

  Shenyang Orthopedic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2017
• First Posted: July 11, 2017
• Study Start: March 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: March 1, 2018
• Last Updated: February 12, 2018

Record last verified: 2018-02