StenosisNCT02485574
Anterior Bridging Cage With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
A study testing transforaminal lumbar interbody arthrodesis in people with Stenosis and Fusion of Spine (Disease), run by Zenoss Co, Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stenosis, Fusion of Spine (Disease)
- What is being tested?
- transforaminal lumbar interbody arthrodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Observational Study of Anterior Bridging Cage Augmented With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
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.
Read the 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.
- Conditions
- Stenosis, Fusion of Spine (Disease)
- Being tested
- transforaminal lumbar interbody arthrodesis
- Keywords
- Bone bridging, Arthrodesis, Lumbar, Cage
- Medical subject headings
- Constriction, Pathologic, Disease, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transforaminal lumbar interbody arthrodesisProcedure or surgery
Also called β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss), Auto-local bone
Anterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in right side of disc space and anterior bridging cages augmented with auto bone in left side of disc space in transforaminal lumbar interbody arthrodesis.
| Study group | Role | What they receive |
|---|---|---|
| Left cage- auto bone | Experimental | At the operated segment, left cage was filled with auto bone only. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis. Receives: Procedure: transforaminal lumbar interbody arthrodesis |
| Right cage- auto local bone mixed with β-calcium phosphate + hydroxyapatite | Experimental | At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis. Receives: Procedure: transforaminal lumbar interbody arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 month postoperatively
Secondary outcomes (1)
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.
Measured: 12 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zenoss Co, Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwang Sup Song, Zenoss Co, Ltd
- Investigators
- Kwang Sup Song, M.D., PhD, Principal investigator, Chung-Ang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485574
- Sponsor's protocol ID
- KSong
- Status last verified
- Nov 2021
- First submitted
- 12 Jun 2015
- Last updated
- 8 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy DR, Hurwitz EL, Gregory A, Clary R. A nonsurgical approach to the management of patients with cervical radiculopathy: a prospective observational cohort study. J Manipulative Physiol Ther. 2006 May;29(4):279-87. doi: 10.1016/j.jmpt.2006.03.005.
PubMed 16690382SMITH GW, ROBINSON RA. The treatment of certain cervical-spine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am. 1958 Jun;40-A(3):607-24. No abstract available.
PubMed 13539086CLOWARD RB. The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958 Nov;15(6):602-17. doi: 10.3171/jns.1958.15.6.0602. No abstract available.
PubMed 13599052Coric D, Branch CL Jr, Jenkins JD. Revision of anterior cervical pseudoarthrosis with anterior allograft fusion and plating. J Neurosurg. 1997 Jun;86(6):969-74. doi: 10.3171/jns.1997.86.6.0969.
PubMed 9171175Savolainen S, Rinne J, Hernesniemi J. A prospective randomized study of anterior single-level cervical disc operations with long-term follow-up: surgical fusion is unnecessary. Neurosurgery. 1998 Jul;43(1):51-5. doi: 10.1097/00006123-199807000-00032.
PubMed 9657188Shapiro S. Banked fibula and the locking anterior cervical plate in anterior cervical fusions following cervical discectomy. J Neurosurg. 1996 Feb;84(2):161-5. doi: 10.3171/jns.1996.84.2.0161.
PubMed 8592216Wang JC, McDonough PW, Endow KK, Delamarter RB. Increased fusion rates with cervical plating for two-level anterior cervical discectomy and fusion. Spine (Phila Pa 1976). 2000 Jan;25(1):41-5. doi: 10.1097/00007632-200001010-00009.
PubMed 10647159Zoega B, Karrholm J, Lind B. Plate fixation adds stability to two-level anterior fusion in the cervical spine: a randomized study using radiostereometry. Eur Spine J. 1998;7(4):302-7. doi: 10.1007/s005860050079.
PubMed 9765038Abd-Alrahman N, Dokmak AS, Abou-Madawi A. Anterior cervical discectomy (ACD) versus anterior cervical fusion (ACF), clinical and radiological outcome study. Acta Neurochir (Wien). 1999;141(10):1089-92. doi: 10.1007/s007010050487.
PubMed 10550654An HS, Simpson JM, Glover JM, Stephany J. Comparison between allograft plus demineralized bone matrix versus autograft in anterior cervical fusion. A prospective multicenter study. Spine (Phila Pa 1976). 1995 Oct 15;20(20):2211-6.
PubMed 8545714Bishop RC, Moore KA, Hadley MN. Anterior cervical interbody fusion using autogeneic and allogeneic bone graft substrate: a prospective comparative analysis. J Neurosurg. 1996 Aug;85(2):206-10. doi: 10.3171/jns.1996.85.2.0206.
PubMed 8755747Cauthen JC, Kinard RE, Vogler JB, Jackson DE, DePaz OB, Hunter OL, Wasserburger LB, Williams VM. Outcome analysis of noninstrumented anterior cervical discectomy and interbody fusion in 348 patients. Spine (Phila Pa 1976). 1998 Jan 15;23(2):188-92. doi: 10.1097/00007632-199801150-00008.
PubMed 9474724Geisler FH, Caspar W, Pitzen T, Johnson TA. Reoperation in patients after anterior cervical plate stabilization in degenerative disease. Spine (Phila Pa 1976). 1998 Apr 15;23(8):911-20. doi: 10.1097/00007632-199804150-00013.
PubMed 9580959Hacker RJ, Cauthen JC, Gilbert TJ, Griffith SL. A prospective randomized multicenter clinical evaluation of an anterior cervical fusion cage. Spine (Phila Pa 1976). 2000 Oct 15;25(20):2646-54; discussion 2655. doi: 10.1097/00007632-200010150-00017.
PubMed 11034651Lofgren H, Johannsson V, Olsson T, Ryd L, Levander B. Rigid fusion after cloward operation for cervical disc disease using autograft, allograft, or xenograft: a randomized study with radiostereometric and clinical follow-up assessment. Spine (Phila Pa 1976). 2000 Aug 1;25(15):1908-16. doi: 10.1097/00007632-200008010-00008.
PubMed 10908933
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study of Anterior Bridging Cage Augmented With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
- ClinicalTrials.gov ID
- NCT02485574
- Acronym / sponsor ID
- KSong
- Conditions
- Stenosis, Fusion of Spine (Disease)
- Keywords
- Bone bridging, Arthrodesis, Lumbar, Cage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Zenoss Co, LtdUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Posted 9 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left cage- auto bone | Experimental | Procedure: transforaminal lumbar interbody arthrodesisAt the operated segment, left cage was filled with auto bone only. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis. |
| Right cage- auto local bone mixed with β-calcium phosphate + hydroxyapatite | Experimental | Procedure: transforaminal lumbar interbody arthrodesisAt the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transforaminal lumbar interbody arthrodesisAlso: β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss), Auto-local boneAnterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in right side of disc space and anterior bridging cages augmented with auto bone in left side of disc space in transforaminal lumbar interbody arthrodesis. | Procedure or surgery | Left cage- auto bone, Right cage- auto local bone mixed with β-calcium phosphate + hydroxyapatite |
Primary outcome
InCBB of Both Cages
Time frame: 12 month postoperatively
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).
1 secondary outcome
ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone
Time frame: 12 month postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16690382Murphy DR, Hurwitz EL, Gregory A, Clary R. A nonsurgical approach to the management of patients with cervical radiculopathy: a prospective observational cohort study. J Manipulative Physiol Ther. 2006 May;29(4):279-87. doi: 10.1016/j.jmpt.2006.03.005.
- Background: PubMed 13539086SMITH GW, ROBINSON RA. The treatment of certain cervical-spine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am. 1958 Jun;40-A(3):607-24. No abstract available.
- Background: PubMed 13599052CLOWARD RB. The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958 Nov;15(6):602-17. doi: 10.3171/jns.1958.15.6.0602. No abstract available.
- Background: PubMed 9171175Coric D, Branch CL Jr, Jenkins JD. Revision of anterior cervical pseudoarthrosis with anterior allograft fusion and plating. J Neurosurg. 1997 Jun;86(6):969-74. doi: 10.3171/jns.1997.86.6.0969.
- Background: PubMed 9657188Savolainen S, Rinne J, Hernesniemi J. A prospective randomized study of anterior single-level cervical disc operations with long-term follow-up: surgical fusion is unnecessary. Neurosurgery. 1998 Jul;43(1):51-5. doi: 10.1097/00006123-199807000-00032.
- Background: PubMed 8592216Shapiro S. Banked fibula and the locking anterior cervical plate in anterior cervical fusions following cervical discectomy. J Neurosurg. 1996 Feb;84(2):161-5. doi: 10.3171/jns.1996.84.2.0161.
- Background: PubMed 10647159Wang JC, McDonough PW, Endow KK, Delamarter RB. Increased fusion rates with cervical plating for two-level anterior cervical discectomy and fusion. Spine (Phila Pa 1976). 2000 Jan;25(1):41-5. doi: 10.1097/00007632-200001010-00009.
- Background: PubMed 9765038Zoega B, Karrholm J, Lind B. Plate fixation adds stability to two-level anterior fusion in the cervical spine: a randomized study using radiostereometry. Eur Spine J. 1998;7(4):302-7. doi: 10.1007/s005860050079.
- Background: PubMed 10550654Abd-Alrahman N, Dokmak AS, Abou-Madawi A. Anterior cervical discectomy (ACD) versus anterior cervical fusion (ACF), clinical and radiological outcome study. Acta Neurochir (Wien). 1999;141(10):1089-92. doi: 10.1007/s007010050487.
- Background: PubMed 8545714An HS, Simpson JM, Glover JM, Stephany J. Comparison between allograft plus demineralized bone matrix versus autograft in anterior cervical fusion. A prospective multicenter study. Spine (Phila Pa 1976). 1995 Oct 15;20(20):2211-6.
- Background: PubMed 8755747Bishop RC, Moore KA, Hadley MN. Anterior cervical interbody fusion using autogeneic and allogeneic bone graft substrate: a prospective comparative analysis. J Neurosurg. 1996 Aug;85(2):206-10. doi: 10.3171/jns.1996.85.2.0206.
- Background: PubMed 9474724Cauthen JC, Kinard RE, Vogler JB, Jackson DE, DePaz OB, Hunter OL, Wasserburger LB, Williams VM. Outcome analysis of noninstrumented anterior cervical discectomy and interbody fusion in 348 patients. Spine (Phila Pa 1976). 1998 Jan 15;23(2):188-92. doi: 10.1097/00007632-199801150-00008.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwang Sup Song, M.D., PhD principal investigator
Chung-Ang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transforaminal lumbar interbody arthrodesis in people with Stenosis and Fusion of Spine (Disease), run by Zenoss Co, Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
InCBB of Both Cages (time frame: 12 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02485574, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.