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

NCT02485574 | Completed Results DMC

• 1 other identifier: KSong
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Stenosis; Fusion of Spine (Disease)

Keywords

Bone bridging; Arthrodesis; Lumbar; Cage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone

  12 month postoperatively

Other Outcomes (1)

• ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score)

  postoperative 1 year

Study Arms (2)

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.

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.

Procedure: transforaminal lumbar interbody arthrodesis

Interventions

transforaminal lumbar interbody arthrodesis PROCEDURE

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.

Also known as: β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss), Auto-local bone

Left cage- auto bone; Right cage- auto local bone mixed with β-calcium phosphate + hydroxyapatite

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zenoss Co, Ltd: lead

Study Sites (1)

Kwang Sup Song

Seoul, South Korea

Location

Related Publications (30)

• 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.

  PMID: 16690382 BACKGROUND

• 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. No abstract available.

  PMID: 13539086 BACKGROUND

• CLOWARD 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.

  PMID: 13599052 BACKGROUND

• 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. doi: 10.3171/jns.1997.86.6.0969.

  PMID: 9171175 BACKGROUND

• 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. doi: 10.1097/00006123-199807000-00032.

  PMID: 9657188 BACKGROUND

• 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. doi: 10.3171/jns.1996.84.2.0161.

  PMID: 8592216 BACKGROUND

• 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. doi: 10.1097/00007632-200001010-00009.

  PMID: 10647159 BACKGROUND

• Zoega 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.

  PMID: 9765038 BACKGROUND

• 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. doi: 10.1007/s007010050487.

  PMID: 10550654 BACKGROUND

• 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.

  PMID: 8545714 BACKGROUND

• 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. doi: 10.3171/jns.1996.85.2.0206.

  PMID: 8755747 BACKGROUND

• 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. doi: 10.1097/00007632-199801150-00008.

  PMID: 9474724 BACKGROUND

• 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. doi: 10.1097/00007632-199804150-00013.

  PMID: 9580959 BACKGROUND

• 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. doi: 10.1097/00007632-200010150-00017.

  PMID: 11034651 BACKGROUND

• Lofgren 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.

  PMID: 10908933 BACKGROUND

• 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. doi: 10.1097/00007632-199801150-00006.

  PMID: 9474723 BACKGROUND

• 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. doi: 10.1097/00007632-199905010-00005.

  PMID: 10327506 BACKGROUND

• 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. doi: 10.1007/s00586-003-0539-6. Epub 2003 Jun 21.

  PMID: 12827473 BACKGROUND

• Bagby GW. Arthrodesis by the distraction-compression method using a stainless steel implant. Orthopedics. 1988 Jun;11(6):931-4. doi: 10.3928/0147-7447-19880601-13.

  PMID: 3387340 BACKGROUND

• 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.

  PMID: 6367560 BACKGROUND

• 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. doi: 10.1097/00007632-200011010-00008.

  PMID: 11064521 BACKGROUND

• 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. doi: 10.1016/j.biomaterials.2005.07.011. Epub 2005 Aug 22.

  PMID: 16115677 BACKGROUND

• Kurtz SM, Devine JN. PEEK biomaterials in trauma, orthopedic, and spinal implants. Biomaterials. 2007 Nov;28(32):4845-69. doi: 10.1016/j.biomaterials.2007.07.013. Epub 2007 Aug 7.

  PMID: 17686513 BACKGROUND

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

  PMID: 18019846 BACKGROUND

• 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.

  PMID: 20153890 BACKGROUND

• 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. doi: 10.1016/j.surneu.2004.10.016.

  PMID: 15936361 BACKGROUND

• 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.

  PMID: 18797946 BACKGROUND

• 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. doi: 10.1016/j.spinee.2006.03.002. Epub 2006 Nov 17.

  PMID: 17321970 BACKGROUND

• 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.

  PMID: 12445338 BACKGROUND

• 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. doi: 10.1016/j.injury.2005.06.012.

  PMID: 15993115 BACKGROUND

MeSH Terms

Conditions

Constriction, Pathologic; Disease; Ankylosis

Interventions

Durapatite

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hydroxyapatites; Apatites; Calcium Phosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Calcium Compounds; Minerals; Phosphorus Compounds

Limitations and Caveats

Suggested criterios can only be used for interbody fusion evaluation.

Results Point of Contact

• Title: Kwang-Sup Song
• Organization: Chung-Ang University hospital

ksong70@cau.ac.kr

+82-1037616503

Study Officials

• Kwang Sup Song, M.D., PhD

  Chung-Ang University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 30, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 8, 2021
• Results First Posted: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)