None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : Iliad Spinal System of Medyssey Co., Ltd. is applied to patients who require posterior spinal fixation due to thracolumbar sacral disease to confirm the treatment e
Sponsors
Medyssey
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those who are 19 years of age or older as of the date of signing the consent form 2) Those who voluntarily decided to participate in the study and signed a written consent form 3) A person who satisfies one of the following conditions: - Patients with spinal deformity - Patients with degenerative spinal disease - Other people who are expected to need posterior spinal device fixation according to the judgment of a specialist.
Exclusion criteria
Exclusion criteria: 1) Active/latent infection, fever, or leukocytosis in or around the spine 2) Those with a history of previous spinal surgery at the surgical site or adjacent area 3) Those in whom screw fixation is not smooth after insertion of pedicle screws due to illness, infection, or injury. 4) Patients with a risk of infection after surgery due to a history of skin disease, including burns, or progression of lesions 5) Those with a history of cancer within 5 years 6) Those who have concomitant diseases or are taking related medications that may affect bone/soft tissue healing 7) Persons with a history of allergy or anaphylaxis to the raw materials of the test device and bone union reinforcement material 8) Severely obese patients with BMI exceeding 35 9) Those who are unable to take radiological images (X-ray, CT) 10) Current smoker 11) Alcohol/drug addicts 12) Those who have a history of psychiatric illness or are receiving medication 13) Women of childbearing age who are pregnant or lactating 14) Those who have the potential to become pregnant and do not agree to contraception using a medically acceptable method during the period of this clinical trial 15) Those who participated in another clinical trial within 30 days from the date of screening 16) Other persons judged by the investigator to be unsuitable for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ODI score change at week 48 compared to baseline evaluated by the subject | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ODI score at weeks 6, 12, 24, and 96 compared to baseline evaluated by the subject;100mm VAS change in back pain at weeks 6, 12, 24, 48, and 96 compared to baseline as assessed by the subject;100mm VAS change in leg pain at weeks 6, 12, 24, 48, and 96 compared to baseline as assessed by the subject;Bone union rate at 12, 24, 48, and 96 weeks after surgery assessed through radiological imaging (X-ray, CT);Damage/dislodgement/looseness of the test device at 6, 12, 24, 48, and 96 weeks after surgery assessed through radiological imaging (X-ray);Degeneration of adjacent segments at 12, 24, 48, and 96 weeks after surgery assessed through radiological imaging (X-ray) | — |
Countries
Korea, Republic of
Contacts
Public ContactByung Ho Lee
Yonsei University Health System, Severance Hospital
Outcome results
None listed