Anterior Bridging Cage With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis

Stenosis Clinical Trial

Official title:

Prospective, Observational Study of Anterior Bridging Cage Augmented With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485574
• Other study ID #: KSong
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: June 2019

Study information

• Verified date: November 2021
• Source: Zenoss Co, Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. In addition, the investigators will analyze anterior new bone bridging pattern between anterior bridging cage newly developed and grafted bone in anterior disc space.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fusion of Spine (Disease)
• Stenosis

Intervention

Procedure:
• transforaminal lumbar interbody arthrodesis
Anterior bridging cages augmented with auto bone plus ß-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.

Locations

Country	Name	City	State
Korea, Republic of	Kwang Sup Song	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Zenoss Co, Ltd

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (30)

Abd-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. — View Citation

An 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. — View Citation

Bagby GW. Arthrodesis by the distraction-compression method using a stainless steel implant. Orthopedics. 1988 Jun;11(6):931-4. — View Citation

Bishop 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. — View Citation

Cauthen 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. Review. — View Citation

Cho DY, Lee WY, Sheu PC, Chen CC. Cage containing a biphasic calcium phosphate ceramic (Triosite) for the treatment of cervical spondylosis. Surg Neurol. 2005 Jun;63(6):497-503; discussion 503-4. — View Citation

Cho DY, Liau WR, Lee WY, Liu JT, Chiu CL, Sheu PC. Preliminary experience using a polyetheretherketone (PEEK) cage in the treatment of cervical disc disease. Neurosurgery. 2002 Dec;51(6):1343-49; discussion 1349-50. Erratum in: Neurosurgery. 2003 Mar;52(3):693. — View Citation

CLOWARD RB. The anterior approach for removal of ruptured cervical disks. J Neurosurg. 1958 Nov;15(6):602-17. — View Citation

Coric 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. — View Citation

DeBowes RM, Grant BD, Bagby GW, Gallina AM, Sande RD, Ratzlaff MH. Cervical vertebral interbody fusion in the horse: a comparative study of bovine xenografts and autografts supported by stainless steel baskets. Am J Vet Res. 1984 Jan;45(1):191-9. — View Citation

Geisler 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. — View Citation

Gercek E, Arlet V, Delisle J, Marchesi D. Subsidence of stand-alone cervical cages in anterior interbody fusion: warning. Eur Spine J. 2003 Oct;12(5):513-6. Epub 2003 Jun 21. — View Citation

Hacker 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. — View Citation

Han CM, Lee EJ, Kim HE, Koh YH, Kim KN, Ha Y, Kuh SU. The electron beam deposition of titanium on polyetheretherketone (PEEK) and the resulting enhanced biological properties. Biomaterials. 2010 May;31(13):3465-70. doi: 10.1016/j.biomaterials.2009.12.030. Epub 2010 Feb 13. — View Citation

Kandziora F, Pflugmacher R, Scholz M, Schnake K, Putzier M, Khodadadyan-Klostermann C, Haas NP. Treatment of traumatic cervical spine instability with interbody fusion cages: a prospective controlled study with a 2-year follow-up. Injury. 2005 Jul;36 Suppl 2:B27-35. — View Citation

Kast E, Derakhshani S, Bothmann M, Oberle J. Subsidence after anterior cervical inter-body fusion. A randomized prospective clinical trial. Neurosurg Rev. 2009 Apr;32(2):207-14; discussion 214. doi: 10.1007/s10143-008-0168-y. Epub 2008 Sep 17. — View Citation

Kulkarni AG, Hee HT, Wong HK. Solis cage (PEEK) for anterior cervical fusion: preliminary radiological results with emphasis on fusion and subsidence. Spine J. 2007 Mar-Apr;7(2):205-9. Epub 2006 Nov 17. — View Citation

Kurtz SM, Devine JN. PEEK biomaterials in trauma, orthopedic, and spinal implants. Biomaterials. 2007 Nov;28(32):4845-69. Epub 2007 Aug 7. Review. — View Citation

Löfgren 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. — View Citation

Lowery GL, McDonough RF. The significance of hardware failure in anterior cervical plate fixation. Patients with 2- to 7-year follow-up. Spine (Phila Pa 1976). 1998 Jan 15;23(2):181-6; discussion 186-7. — View Citation

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. — View Citation

Savolainen 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. — View Citation

Shapiro S. Banked fibula and the locking anterior cervical plate in anterior cervical fusions following cervical discectomy. J Neurosurg. 1996 Feb;84(2):161-5. — View Citation

SMITH 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. — View Citation

Toth JM, Wang M, Estes BT, Scifert JL, Seim HB 3rd, Turner AS. Polyetheretherketone as a biomaterial for spinal applications. Biomaterials. 2006 Jan;27(3):324-34. Epub 2005 Aug 22. — View Citation

Tribus CB, Corteen DP, Zdeblick TA. The efficacy of anterior cervical plating in the management of symptomatic pseudoarthrosis of the cervical spine. Spine (Phila Pa 1976). 1999 May 1;24(9):860-4. — View Citation

Wang 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. — View Citation

Wilke HJ, Kettler A, Goetz C, Claes L. Subsidence resulting from simulated postoperative neck movements: an in vitro investigation with a new cervical fusion cage. Spine (Phila Pa 1976). 2000 Nov 1;25(21):2762-70. — View Citation

Yao C, Storey D, Webster TJ. Nanostructured metal coatings on polymers increase osteoblast attachment. Int J Nanomedicine. 2007;2(3):487-92. — View Citation

Zoëga B, Kärrholm 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. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

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