Clinical trial NCT02485574: Anterior Bridging Cage With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
Official title: Prospective, Observational Study of Anterior Bridging Cage Augmented With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenosis
Fusion of Spine (Disease)
Keywords: Bone bridging
Arthrodesis
Lumbar
Cage
Lead sponsor: Zenoss Co, Ltd
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A single center, observational, single arm study to evaluate the efficacy of auto local bone mixed with β-calcium phosphate + hydroxyapatite using interbody fusion assessment on multi-axial CT scan. Its active comparator is auto local bone.

Anterior bridging bone between anterior grafted bone and inserted cage will be assessed by using newly developed anterior bridging cage as well as interbody bone bridging between two vertebral bodies on multi-axial reconstructed CT scan.

The patients undergoes arthrodesis surgery will have two cages, one augmented with auto local bone will be located at left side of disc space and the other cage augmented with auto local bone mixed with β-calcium phosphate + hydroxyapatite at right side of disc space.

Eligibility criteria: 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

Primary outcomes:
measure: InCBB of Both Cages
timeFrame: 12 month postoperatively
Secondary outcomes:
measure: ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone
timeFrame: 12 month postoperatively
Other outcomes:
measure: ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score)
timeFrame: postoperative 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Kwang Sup Song
Study officials:
affiliation: Chung-Ang University
name: Kwang Sup Song, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
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