Cervical ArthrodesisNCT02178605

rhBMP-2 in Cervical Arthrodesis

An observational study of Cervical Arthrodesis, run by Virginia Spine Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This prospective study will investigate the use of recombinant human bone morphogenetic protein (rhBMP-2) in the current surgical standard of care for cervical spine pathology. Specifically, the outcomes of three forms of cervical fusion will be investigated: 1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cervical Arthrodesis
What is being tested?: Cervical arthrodesis with rhBMP-2
Type of treatment: Surgery or procedure
How many people: 300 participants
Where: 1 siteUnited States
Study dates: Oct 2008to Dec 2017
Phase: Observational
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients presenting at a single site and candidates for cervical arthrodesis

Who may be able to join

Has cervical spine pathology as noted by neck pain with or without arm symptoms, functional deficit and/or neurological deficit, confirmed by patient history, as well as radiographic imaging studies:
CT, MRI scan, x-ray imaging are to include one or more of the following:
Instability, as defined by translational motion greater than or equal to 3.5 mm or angular motion greater than 11° at a single segment based upon flexion/extension radiographs.
Osteophyte formation.
Decreased disc space height.
Facet joint degeneration.

Show all 13Show fewer

Disc herniation or protrusion.
Signs or symptoms of spinal cord compression (i.e., myelopathy).
One or more symptomatic levels of degeneration between C3 and C7.
Age 18 years of age or older at the time of surgery.
Has not responded to nonoperative treatments including restricted activity, physical therapy, medications, corticosteroid injections, manipulation, TENS for a period of at least three months.
If female of childbearing age who is not pregnant or nursing and who agrees to use adequate contraception for at least six months following surgery.
Is willing and able to comply with the study protocol, sign the patient informed consent form, and able to sign the authorization to disclose health information consent form.

Who cannot join

Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
Has active malignancy.
Has overt or active bacterial infection, either local or systemic.
Has fever (temperature greater than 101° Fahrenheit oral at the time of surgery).
Has a documented titanium alloy allergy or allergy to bovine collagen.

Show all 14Show fewer

Is mentally incompetent.
Has a Waddell sign of inorganic behavior score of 3 or greater.
Is a prisoner.
Is an alcohol and/or drug abuser, as defined by currently undergoing treatment for alcohol and/or drug abuse.
Has a history of autoimmune disease.
Has a hypersensitivity to protein pharmaceuticals, monoclonal antibodies, gammaglobulin, or collagen.
Has a history of endocrine of metabolic disorder known to affect osteogenesis.
Is currently pregnant or plans on becoming pregnant within the six months following the surgical procedure

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Spine Institute
Reston, Virginia, 20190

Other trials in United States

About this study

Official title: A Prospective Non-Randomized Investigation Of The Use Of Infuse® (rhBMP-2) In Cervical Arthrodesis

Anterior cervical fusion with rhBMP-2, allograft corticocancellous bone as an interbody device, and anterior cervical plate fixation.
Posterior cervical fusion with rhBMP-2, local bone graft, with or without posterior screw fixation.
A combination of the previous two approaches: a combined anterior-posterior cervical fusion with rhBMP-2.

Read the detailed description

SURGICAL TECHNIQUES

Anterior cervical fusion The technique of anterior cervical discectomy and arthrodesis of the spine has been previously described by Smith-Robinson (ref) and is an accepted technique for anterior cervical fusion. Upon completion of adequate decompression, a gentle distraction maneuver may be performed by using either Caspar distraction pins or an interbody spreading device, taking care to avoid injury to the endplates. The endplates are then prepared with the use of a rasp or high speed burr taken to both superior and inferior endplates to remove the cartilagenous material and identify the bony endplate. Once hemostasis is obtained, the appropriate size allograft implant is chosen. That implant is then defrosted and brought into the surgical field. Concurrently, rhBMP-2 ((INFUSE®) Medtronic, Inc. Minneapolis, MN) has been reconstituted with sterile water, placed on an absorbable (type I bovine) collage sponge (ACS), cut to deliver the appropriate dose to each spinal level and is on the field as well. The partial BMP/ACS sponge is inserted into each disc space level, posterior to the structural implant. The dosage of rhBMP-2 used is approximately 0.525 mg per disc level or interbody space treated. The interbody device utilized is LifeNet Health's VertiGraft® VG2®. In the case of these allograft intervertebral implants, product safety and efficacy has been validated and patented by LifeNet Health using both an Allowash® and Allowash XG® technology. This is an intensive decontamination, disinfection and scrubbing regimen to remove and inactivate both viruses and bacteria which may be present from the donor harvesting process. The Allowash® process removes virtually all cellular elements of the bone thereby providing an additional line of defense against infectious disease. The second step consists of terminal sterilization of the cortico-cancellous allograft tissue. These processes have been validated and render the tissue sterile without compromising either the biomechanical or biochemical properties of allograft tissue intended for spinal applications. Plate fixation with the Atlantis® Cervical Plate (Medtronic, Inc. Minneapolis, MN) is carried out by serially drilling each of the screw holes and placing the appropriate length (3.5 x 14-15 mm) screw into each of the holes. The locking screw mechanism on the plate is then secured and a lateral cervical radiograph is called for to confirm appropriate levels and instrumentation placement. A medium Hemovac drain is placed in the anterior prevertebral space and brought out through a separate stab incision. Routine closure is then carried out.
Posterior Cervical Arthrodesis A longitudinal incision is made in the midline of the posterior neck, directly over the involved spinal level(s). The fascia and muscle are gently divided, exposing the spinous processes and lamina. An x-ray is obtained to confirm the appropriate spinal levels to be fused. A laminectomy and foraminotomy can be performed if necessary. Two (3.5 mm x 14mm) cortical screws ((Vertex (TM) Medtronic, Inc. Minneapolis, MN) are affixed to each lateral mass in the method previous described by Magerl (ref) and connected with a titanium rod on each side of the spine. The bony surfaces and facet joints are then decorticated. One sponge of the BMP/ACS product is placed over the decorticated bone surfaces on each side. The bone removed during the decompresion laminectomy is morsellized and placed in and around the facet joints. The amount of rh-BMP-2 used will be a total of 2.1 mg placed bilaterally, to a total of 4.2mg.
Combined Anterior-Posterior Cervical Arthrodesis This surgical procedure combines a posterior cervical decompression and fusion with an anterior cervical fusion. The techniques described for the individual surgical procedures are applicable to the combined Anterior-Posterior procedure. In an anterior-posterior surgery, the amount and positioning of rhBMP-2 will be similar to the anterior surgery (0.525 mg placed anteriorly at each level) or similar to the posterior surgery (2.4 mg across the entire lateral mass on each side posteriorly).

Conditions: Cervical Arthrodesis
Being tested: Cervical arthrodesis with rhBMP-2
Keywords: rhBMP-2, arthrodesis, cervical
Medical subject headings: Ankylosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cervical arthrodesis with rhBMP-2Procedure or surgery
Also called Infuse
Cervical arthrodesis with rhBMP-2

Study groups in NCT02178605
Study group	Role	What they receive
Cervical arthrodesis candidates		Patients scheduled to undergo cervical arthrodesis to treat their spinal pathology will undergo cervical arthrodesis with rhBMP-2 Receives: Procedure: Cervical arthrodesis with rhBMP-2

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Serious and Non-Serious Adverse Events
Number of Participants with Serious and Non-Serious Adverse Events intra-operative and up to 2 years post-operative
Measured: Up to 2 years

Secondary outcomes (1)

Improvement in patient-reported outcomes
Change from pre-operative to 2-year post-operative n disability, neck pain, arm pain, and health
Measured: Pre-operative up to 2 years post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Dec 2017

First posted1 Jul 2014 (estimated)
Study startOct 2008
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Cervical ArthrodesisStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02178605
Sponsor's protocol ID: 08-07
Status last verified: Oct 2016
First submitted: 26 Jun 2014
Last updated: 12 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ong KL, Villarraga ML, Lau E, Carreon LY, Kurtz SM, Glassman SD. Off-label use of bone morphogenetic proteins in the United States using administrative data. Spine (Phila Pa 1976). 2010 Sep 1;35(19):1794-800. doi: 10.1097/BRS.0b013e3181ecf6e4.
PubMed 20700081
Perri B, Cooper M, Lauryssen C, Anand N. Adverse swelling associated with use of rh-BMP-2 in anterior cervical discectomy and fusion: a case study. Spine J. 2007 Mar-Apr;7(2):235-9. doi: 10.1016/j.spinee.2006.04.010. Epub 2006 Nov 20.
PubMed 17321975
Mroz TE, Wang JC, Hashimoto R, Norvell DC. Complications related to osteobiologics use in spine surgery: a systematic review. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S86-104. doi: 10.1097/BRS.0b013e3181d81ef2.
PubMed 20407355
Cahill KS, Chi JH, Day A, Claus EB. Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures. JAMA. 2009 Jul 1;302(1):58-66. doi: 10.1001/jama.2009.956.
PubMed 19567440
Williams BJ, Smith JS, Fu KM, Hamilton DK, Polly DW Jr, Ames CP, Berven SH, Perra JH, Knapp DR Jr, McCarthy RE, Shaffrey CI; Scoliosis Research Society Morbidity and Mortality Committee. Does bone morphogenetic protein increase the incidence of perioperative complications in spinal fusion? A comparison of 55,862 cases of spinal fusion with and without bone morphogenetic protein. Spine (Phila Pa 1976). 2011 Sep 15;36(20):1685-91. doi: 10.1097/BRS.0b013e318216d825.
PubMed 21897187
Fineberg SJ, Ahmadinia K, Oglesby M, Patel AA, Singh K. Hospital outcomes and complications of anterior and posterior cervical fusion with bone morphogenetic protein. Spine (Phila Pa 1976). 2013 Jul 1;38(15):1304-9. doi: 10.1097/BRS.0b013e31828f494c.
PubMed 23462577
Tumialan LM, Pan J, Rodts GE, Mummaneni PV. The safety and efficacy of anterior cervical discectomy and fusion with polyetheretherketone spacer and recombinant human bone morphogenetic protein-2: a review of 200 patients. J Neurosurg Spine. 2008 Jun;8(6):529-35. doi: 10.3171/SPI/2008/8/6/529.
PubMed 18518673
Frenkel MB, Cahill KS, Javahary RJ, Zacur G, Green BA, Levi AD. Fusion rates in multilevel, instrumented anterior cervical fusion for degenerative disease with and without the use of bone morphogenetic protein. J Neurosurg Spine. 2013 Mar;18(3):269-73. doi: 10.3171/2012.12.SPINE12607. Epub 2013 Jan 25.
PubMed 23350532
Lanman TH, Hopkins TJ. Early findings in a pilot study of anterior cervical interbody fusion in which recombinant human bone morphogenetic protein-2 was used with poly(L-lactide-co-D,L-lactide) bioabsorbable implants. Neurosurg Focus. 2004 Mar 15;16(3):E6.
PubMed 15198494
Shields LB, Raque GH, Glassman SD, Campbell M, Vitaz T, Harpring J, Shields CB. Adverse effects associated with high-dose recombinant human bone morphogenetic protein-2 use in anterior cervical spine fusion. Spine (Phila Pa 1976). 2006 Mar 1;31(5):542-7. doi: 10.1097/01.brs.0000201424.27509.72.
PubMed 16508549
Boakye M, Mummaneni PV, Garrett M, Rodts G, Haid R. Anterior cervical discectomy and fusion involving a polyetheretherketone spacer and bone morphogenetic protein. J Neurosurg Spine. 2005 May;2(5):521-5. doi: 10.3171/spi.2005.2.5.0521.
PubMed 15945426
Stachniak JB, Diebner JD, Brunk ES, Speed SM. Analysis of prevertebral soft-tissue swelling and dysphagia in multilevel anterior cervical discectomy and fusion with recombinant human bone morphogenetic protein-2 in patients at risk for pseudarthrosis. J Neurosurg Spine. 2011 Feb;14(2):244-9. doi: 10.3171/2010.9.SPINE09828. Epub 2010 Dec 24.
PubMed 21184639
Baskin DS, Ryan P, Sonntag V, Westmark R, Widmayer MA. A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate. Spine (Phila Pa 1976). 2003 Jun 15;28(12):1219-24; discussion 1225. doi: 10.1097/01.BRS.0000065486.22141.CA.
PubMed 12811263
Smucker JD, Rhee JM, Singh K, Yoon ST, Heller JG. Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine. Spine (Phila Pa 1976). 2006 Nov 15;31(24):2813-9. doi: 10.1097/01.brs.0000245863.52371.c2.
PubMed 17108835
Vaidya R, Carp J, Sethi A, Bartol S, Craig J, Les CM. Complications of anterior cervical discectomy and fusion using recombinant human bone morphogenetic protein-2. Eur Spine J. 2007 Aug;16(8):1257-65. doi: 10.1007/s00586-007-0351-9. Epub 2007 Mar 27.
PubMed 17387522

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
Cervical Fusion
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
Active, not recruiting
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
Not yet recruiting
Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease
Degenerative Disc Disease(DDD)

All Cervical Arthrodesis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Non-Randomized Investigation Of The Use Of Infuse® (rhBMP-2) In Cervical Arthrodesis
ClinicalTrials.gov ID: NCT02178605
Acronym / sponsor ID: 08-07
Conditions: Cervical Arthrodesis
Keywords: rhBMP-2, arthrodesis, cervical
Study type: Observational
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Virginia Spine InstituteUniversity, hospital or other
Study start: Oct 2008
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 1 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Anterior cervical fusion with rhBMP-2, allograft corticocancellous bone as an interbody device, and anterior cervical plate fixation.
Posterior cervical fusion with rhBMP-2, local bone graft, with or without posterior screw fixation.
A combination of the previous two approaches: a combined anterior-posterior cervical fusion with rhBMP-2.

Detailed description

SURGICAL TECHNIQUES

Anterior cervical fusion The technique of anterior cervical discectomy and arthrodesis of the spine has been previously described by Smith-Robinson (ref) and is an accepted technique for anterior cervical fusion. Upon completion of adequate decompression, a gentle distraction maneuver may be performed by using either Caspar distraction pins or an interbody spreading device, taking care to avoid injury to the endplates. The endplates are then prepared with the use of a rasp or high speed burr taken to both superior and inferior endplates to remove the cartilagenous material and identify the bony endplate. Once hemostasis is obtained, the appropriate size allograft implant is chosen. That implant is then defrosted and brought into the surgical field. Concurrently, rhBMP-2 ((INFUSE®) Medtronic, Inc. Minneapolis, MN) has been reconstituted with sterile water, placed on an absorbable (type I bovine) collage sponge (ACS), cut to deliver the appropriate dose to each spinal level and is on the field as well. The partial BMP/ACS sponge is inserted into each disc space level, posterior to the structural implant. The dosage of rhBMP-2 used is approximately 0.525 mg per disc level or interbody space treated. The interbody device utilized is LifeNet Health's VertiGraft® VG2®. In the case of these allograft intervertebral implants, product safety and efficacy has been validated and patented by LifeNet Health using both an Allowash® and Allowash XG® technology. This is an intensive decontamination, disinfection and scrubbing regimen to remove and inactivate both viruses and bacteria which may be present from the donor harvesting process. The Allowash® process removes virtually all cellular elements of the bone thereby providing an additional line of defense against infectious disease. The second step consists of terminal sterilization of the cortico-cancellous allograft tissue. These processes have been validated and render the tissue sterile without compromising either the biomechanical or biochemical properties of allograft tissue intended for spinal applications. Plate fixation with the Atlantis® Cervical Plate (Medtronic, Inc. Minneapolis, MN) is carried out by serially drilling each of the screw holes and placing the appropriate length (3.5 x 14-15 mm) screw into each of the holes. The locking screw mechanism on the plate is then secured and a lateral cervical radiograph is called for to confirm appropriate levels and instrumentation placement. A medium Hemovac drain is placed in the anterior prevertebral space and brought out through a separate stab incision. Routine closure is then carried out.
Posterior Cervical Arthrodesis A longitudinal incision is made in the midline of the posterior neck, directly over the involved spinal level(s). The fascia and muscle are gently divided, exposing the spinous processes and lamina. An x-ray is obtained to confirm the appropriate spinal levels to be fused. A laminectomy and foraminotomy can be performed if necessary. Two (3.5 mm x 14mm) cortical screws ((Vertex (TM) Medtronic, Inc. Minneapolis, MN) are affixed to each lateral mass in the method previous described by Magerl (ref) and connected with a titanium rod on each side of the spine. The bony surfaces and facet joints are then decorticated. One sponge of the BMP/ACS product is placed over the decorticated bone surfaces on each side. The bone removed during the decompresion laminectomy is morsellized and placed in and around the facet joints. The amount of rh-BMP-2 used will be a total of 2.1 mg placed bilaterally, to a total of 4.2mg.
Combined Anterior-Posterior Cervical Arthrodesis This surgical procedure combines a posterior cervical decompression and fusion with an anterior cervical fusion. The techniques described for the individual surgical procedures are applicable to the combined Anterior-Posterior procedure. In an anterior-posterior surgery, the amount and positioning of rhBMP-2 will be similar to the anterior surgery (0.525 mg placed anteriorly at each level) or similar to the posterior surgery (2.4 mg across the entire lateral mass on each side posteriorly).

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cervical arthrodesis candidates	–	Procedure: Cervical arthrodesis with rhBMP-2Patients scheduled to undergo cervical arthrodesis to treat their spinal pathology will undergo cervical arthrodesis with rhBMP-2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients presenting at a single site and candidates for cervical arthrodesis

Key inclusion criteria (13 listed)

Has cervical spine pathology as noted by neck pain with or without arm symptoms, functional deficit and/or neurological deficit, confirmed by patient history, as well as radiographic imaging studies:
One or more symptomatic levels of degeneration between C3 and C7.
Age 18 years of age or older at the time of surgery.
Has not responded to nonoperative treatments including restricted activity, physical therapy, medications, corticosteroid injections, manipulation, TENS for a period of at least three months.
If female of childbearing age who is not pregnant or nursing and who agrees to use adequate contraception for at least six months following surgery.

Key exclusion criteria (14 listed)

Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
Has active malignancy.
Has overt or active bacterial infection, either local or systemic.
Has fever (temperature greater than 101° Fahrenheit oral at the time of surgery).

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
Cervical arthrodesis with rhBMP-2Also: InfuseCervical arthrodesis with rhBMP-2	Procedure or surgery	Cervical arthrodesis candidates

Primary outcome

Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to 2 years
Number of Participants with Serious and Non-Serious Adverse Events intra-operative and up to 2 years post-operative

1 secondary outcome

Improvement in patient-reported outcomes
Time frame: Pre-operative up to 2 years post-operative

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
Background: PubMed 20700081Ong KL, Villarraga ML, Lau E, Carreon LY, Kurtz SM, Glassman SD. Off-label use of bone morphogenetic proteins in the United States using administrative data. Spine (Phila Pa 1976). 2010 Sep 1;35(19):1794-800. doi: 10.1097/BRS.0b013e3181ecf6e4.
Background: PubMed 17321975Perri B, Cooper M, Lauryssen C, Anand N. Adverse swelling associated with use of rh-BMP-2 in anterior cervical discectomy and fusion: a case study. Spine J. 2007 Mar-Apr;7(2):235-9. doi: 10.1016/j.spinee.2006.04.010. Epub 2006 Nov 20.
Background: PubMed 20407355Mroz TE, Wang JC, Hashimoto R, Norvell DC. Complications related to osteobiologics use in spine surgery: a systematic review. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S86-104. doi: 10.1097/BRS.0b013e3181d81ef2.
Background: PubMed 19567440Cahill KS, Chi JH, Day A, Claus EB. Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures. JAMA. 2009 Jul 1;302(1):58-66. doi: 10.1001/jama.2009.956.
Background: PubMed 21897187Williams BJ, Smith JS, Fu KM, Hamilton DK, Polly DW Jr, Ames CP, Berven SH, Perra JH, Knapp DR Jr, McCarthy RE, Shaffrey CI; Scoliosis Research Society Morbidity and Mortality Committee. Does bone morphogenetic protein increase the incidence of perioperative complications in spinal fusion? A comparison of 55,862 cases of spinal fusion with and without bone morphogenetic protein. Spine (Phila Pa 1976). 2011 Sep 15;36(20):1685-91. doi: 10.1097/BRS.0b013e318216d825.
Background: PubMed 23462577Fineberg SJ, Ahmadinia K, Oglesby M, Patel AA, Singh K. Hospital outcomes and complications of anterior and posterior cervical fusion with bone morphogenetic protein. Spine (Phila Pa 1976). 2013 Jul 1;38(15):1304-9. doi: 10.1097/BRS.0b013e31828f494c.
Background: PubMed 18518673Tumialan LM, Pan J, Rodts GE, Mummaneni PV. The safety and efficacy of anterior cervical discectomy and fusion with polyetheretherketone spacer and recombinant human bone morphogenetic protein-2: a review of 200 patients. J Neurosurg Spine. 2008 Jun;8(6):529-35. doi: 10.3171/SPI/2008/8/6/529.
Background: PubMed 23350532Frenkel MB, Cahill KS, Javahary RJ, Zacur G, Green BA, Levi AD. Fusion rates in multilevel, instrumented anterior cervical fusion for degenerative disease with and without the use of bone morphogenetic protein. J Neurosurg Spine. 2013 Mar;18(3):269-73. doi: 10.3171/2012.12.SPINE12607. Epub 2013 Jan 25.
Background: PubMed 15198494Lanman TH, Hopkins TJ. Early findings in a pilot study of anterior cervical interbody fusion in which recombinant human bone morphogenetic protein-2 was used with poly(L-lactide-co-D,L-lactide) bioabsorbable implants. Neurosurg Focus. 2004 Mar 15;16(3):E6.
Background: PubMed 16508549Shields LB, Raque GH, Glassman SD, Campbell M, Vitaz T, Harpring J, Shields CB. Adverse effects associated with high-dose recombinant human bone morphogenetic protein-2 use in anterior cervical spine fusion. Spine (Phila Pa 1976). 2006 Mar 1;31(5):542-7. doi: 10.1097/01.brs.0000201424.27509.72.
Background: PubMed 15945426Boakye M, Mummaneni PV, Garrett M, Rodts G, Haid R. Anterior cervical discectomy and fusion involving a polyetheretherketone spacer and bone morphogenetic protein. J Neurosurg Spine. 2005 May;2(5):521-5. doi: 10.3171/spi.2005.2.5.0521.
Background: PubMed 21184639Stachniak JB, Diebner JD, Brunk ES, Speed SM. Analysis of prevertebral soft-tissue swelling and dysphagia in multilevel anterior cervical discectomy and fusion with recombinant human bone morphogenetic protein-2 in patients at risk for pseudarthrosis. J Neurosurg Spine. 2011 Feb;14(2):244-9. doi: 10.3171/2010.9.SPINE09828. Epub 2010 Dec 24.
Virginia Spine InstituteLink provided by the sponsor.

Related trials for Cervical Arthrodesis

RecruitingObservational study
Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers
Cervical Fusion
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Recruiting
Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
Active, not recruiting
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
Not yet recruiting
Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease
Degenerative Disc Disease(DDD)

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.

Brian R Subach, MD principal investigator

Virginia Spine Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Arthrodesis, run by Virginia Spine Institute at 1 site in United States.

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 13 inclusion and 14 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 12 Oct 2018. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants with Serious and Non-Serious Adverse Events (time frame: Up to 2 years). 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 NCT02178605, which also lists 21 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 12 Oct 2018.