Minimally invasive neurotransmitter using an expandable cage in lumbar degenerative intervertebral disc disease Extending the intervertebral height and anterior full angle of the Transforaminal Lumbar Interbody Fusion Evaluating the effectiveness and safety of restoratio

Not Applicable

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0008813
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Adults between the ages of 19 and 75
2. Patients with lumbar degenerative intervertebral disc disease requiring intervertebral fusion between L2 and S1
3. Patients who have heard and agreed in writing voluntarily, are willing to comply with the protocol, and are willing to visit the hospital to evaluate the observation items

Exclusion Criteria

1) Patients with non-degenerative lumbar disorders such as spinal trauma, spinal tumors, spinal infections and inflammation, and re-operation
2) Pregnant, lactating, or pregnant women who plan to conceive or disagree with medically acceptable contraception during this trial * Medically acceptable contraception: condoms, oral contraceptives lasting at least 3 months, injections or implantation, etc
3) Malignant tumor patients within 5 years
4) Patients taking chronic steroids and corticosteroids [for example, when taking dexamethasone at a dose of 10mg per day for more than 4 weeks]
5) Those currently diagnosed with the following diseases: A)Severe heart disease or liver dysfunction B) Infectious disease, uncorrected blood clotting disorder (platelet<50,000/µl, PT-INR>2.0) C) Osteomalacia, Paget's disease D) Others (syphilis, severe epilepsy, alcohol/drug addiction)
6) Those who have had an allergic reaction or are sensitive to the product itself or its components, which are medical devices of this clinical trial
* Raw materials for medical devices for clinical trials: titanium alloy (Ti-6AI-4VELLI)/PEEK (Polyether ether ketone)/Tantalum
7) Those who have participated in other clinical trials within the last 6 months
8) Those who are judged inappropriate for clinical trials by the principal investigator or other researchers

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1) Comparison of anterior and posterior disc height of fusion segment (2) Comparison of neuroforaminal height of fusion segment (3) Comparison of segmental lordosis of upper and lower vertebral body of fusion segment

Secondary Outcome Measures

Name	Time	Method
bone union rate, sedimentation rate;Cage breakage rate, cage migration rate;VAS (Visual Analogue Scale) score improvement rate, ODI (Oswestry Disability Index) score improvement rate;comparison of anterior and posterior disc height of fusion segment, comparison of neuroforaminal height of fusion segment, comparison of segmental lordosis of fusion segment upper and lower vertebral bodies