Stenosis Clinical Trial
Official title:
Prospective, Observational Study of Anterior Bridging Cage Augmented With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
NCT number | NCT02485574 |
Other study ID # | KSong |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | June 2019 |
Verified date | November 2021 |
Source | Zenoss Co, Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluation for the pattern of bone bridging of patients who undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not inferior to auto local bone only. In addition, the investigators will analyze anterior new bone bridging pattern between anterior bridging cage newly developed and grafted bone in anterior disc space.
Status | Completed |
Enrollment | 69 |
Est. completion date | June 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients who need lumbar interbody fusion in Degenerative spine disease on L1-S1(Spinal stenosis, HIVD and internal derangement of disk, spine instability) - Patients who have no communication problems - Patients who are willing to visit the hospital for any follow-up assessment - Patients who voluntarily sign on a written consent Exclusion Criteria: - Patients who have infection - Patients who have bleeding disorders - Patients who have immunosuppressed disease - Patients who can't sign on consent form - Patients who are in pregnancy or breast feeding - Patients who have severe osteoporosis - Patients who can't take general surgery because of severe liver disease or decreased renal function - Patients who have acute spinal injury, spinal tumor or inflammatory spinal disease |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kwang Sup Song | Seoul |
Lead Sponsor | Collaborator |
---|---|
Zenoss Co, Ltd |
Korea, Republic of,
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score) | The Oswestry Disability Index (ODI) is an index used by clinicians and researchers to quantify disability for low back pain.
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. 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. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. |
postoperative 1 year | |
Primary | InCBB of Both Cages | We used the concept of InCBB (intra-cage bridging bone) to evaluate the fusion status. InCBB was defined as the bridging bone between the upper and lower vertebrae through the void of the cage(s) and divided into right (Rt.) and left (Lt.) InCBB according to the cage position. We graded bridging scores from 0 to 2 based on the degree of completion of the bridging bone in InCBBs (grade 0: no bridging at the superior and inferior endplates; grade 1: incomplete bridging; bridging at the superior or inferior endplate, but with a clear radiolucent line; grade 2: complete bridging). | 12 month postoperatively | |
Secondary | ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone | We defined ABB as the bridging bone between the extra-cage grafted bone and intra-cage grafted bone through the holes in each cage. Since the cages used in this study each have 4 anterior holes, there can be a minimum of 0 and a maximum of 8 ABBs in a patient. | 12 month postoperatively |
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