Efficacy and Safety Study of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Bone Marrow

NCT01335243 | Completed Phase 2 DMC

• 1 other identifier: CHUBX 2010/21
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this clinical study is the estimation of the rate of intersomatic fusion observed 12 months after lumbar interbody fusion by posterior approach with PEEK interbody cage of fusion in PEEK performed with autologous bone of decortication and osseous substitute with a biomaterial (MatriBONE associated with the autologous bone marrow), associated with a posterolateral bone graft performed with MatriBone waxed with bone marrow. Indication is dedicated for patients by painful degenerative osteoarthritis, by narrow lumbar canal and\\or spondylolisthesis.

Conditions

Degenerative Osteoarthritis; Degenerative Lumbar Vertebra

Keywords

Orthopedic Procedures; Spine; Interbody fusion; Arthrodesis; Lumbar Vertebrae; CT Scan; Spine balance; Instrumented fusion; Posterior fusion; Degenerative spine; painful

Outcome Measures

Primary Outcomes (1)

• patients' proportion which an intervertebral fusion

  The main assessment criteria of this study are patients' proportion which an intervertebral fusion is documented to CT scanners The intervertebral fusion is documented by the revealing of at least an osseous continuous span of a vertebral level in the other one on one of three CT scan slides centred on the cage.

  12 months

Secondary Outcomes (3)

• NOTION OF TOLERANCE: Frequency and gravity of unwanted Adverse Events linked to the procedure and\or the use of the biomaterial

  12 months

• Evaluation of the pain

  12 months

• Quality of life evaluation

  12 years

Study Arms (1)

TLIF surgery

EXPERIMENTAL

Procedure: The Transforaminal Lumbar Interbody Fusion (TLIF) surgery

Interventions

The Transforaminal Lumbar Interbody Fusion (TLIF) surgery PROCEDURE

The TLIF surgery use a per-operating artificial substitute specific biomaterial: autologous osteoblasts punctured on iliac crest and put on a collagen support waxed with tri-calcium phosphate (which is osteoconductive) to perform a intervertebral body fusion.

TLIF surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 65 years old.
• Body mass index lower than 35
• Degenerative osteoarthritis painful and invalidating degenerative lumbar vertebra for at least 6 months and resistance fighter in the conservative treatment
• Narrow lumbar canal and\\or spondylolisthesis with neurological disorder associated with signs of primary instability or induced to neurological liberation
• Patient requiring a surgery on a single interbody level.
• Given informed consent
• Patient with French health system

You may not qualify if:

• For women: no efficient contraception (intra uterine device, or contraceptive pill)
• Pregnant or feeding women
• Surgery zone local infection local
• Lumbar interbody fusion of more than two levels
• Spondylolisthesis of high rank (stage 3 or 4 of the classification of Meyerding)
• Scoliosis lumbar vertebra gives a complex to (Cobb angle\> 40°)
• All surgical contraindications
• Severe hyperparathyroidism: calcium \> 2,45 mmol/l and \[PTH\] ≥ 50pg / ml
• Uncontrolled diabetes (untreated or non stabilized by treatment)
• Long corticoid treatment (more than 6 months and stopped since less than 3 months)
• Current Chemotherapy or during the last three months
• Antecedent of regional radiotherapy
• All contraindication to MatriTM BONE: osteomyelitis, bone degenerative disease or necrosis of surgery site.
• Known turned out Osteoporosis untreated (dexa: \> 2 DS)
• Person placed under protection of justice

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Biom'Up France SAS: collaborator

Study Sites (1)

Unité d'Orthopédie-Traumatologie rachis II, Pellegrin

Bordeaux, 33076, France

Location

Related Publications (17)

• Anand N, Hamilton JF, Perri B, Miraliakbar H, Goldstein T. Cantilever TLIF with structural allograft and RhBMP2 for correction and maintenance of segmental sagittal lordosis: long-term clinical, radiographic, and functional outcome. Spine (Phila Pa 1976). 2006 Sep 15;31(20):E748-53. doi: 10.1097/01.brs.0000240211.23617.ae.

  PMID: 16985443 BACKGROUND

• Battie MC, Videman T, Levalahti E, Gill K, Kaprio J. Genetic and environmental effects on disc degeneration by phenotype and spinal level: a multivariate twin study. Spine (Phila Pa 1976). 2008 Dec 1;33(25):2801-8. doi: 10.1097/BRS.0b013e31818043b7.

  PMID: 19050586 BACKGROUND

• Battie MC, Videman T, Kaprio J, Gibbons LE, Gill K, Manninen H, Saarela J, Peltonen L. The Twin Spine Study: contributions to a changing view of disc degeneration. Spine J. 2009 Jan-Feb;9(1):47-59. doi: 10.1016/j.spinee.2008.11.011.

  PMID: 19111259 BACKGROUND

• Carter JD, Swearingen AB, Chaput CD, Rahm MD. Clinical and radiographic assessment of transforaminal lumbar interbody fusion using HEALOS collagen-hydroxyapatite sponge with autologous bone marrow aspirate. Spine J. 2009 Jun;9(6):434-8. doi: 10.1016/j.spinee.2008.11.004. Epub 2008 Dec 25.

  PMID: 19111510 BACKGROUND

• Chen Z, Zhao J, Liu A, Yuan J, Li Z. Surgical treatment of recurrent lumbar disc herniation by transforaminal lumbar interbody fusion. Int Orthop. 2009 Feb;33(1):197-201. doi: 10.1007/s00264-008-0531-1. Epub 2008 Mar 21.

  PMID: 18357449 BACKGROUND

• el-Masry MA, Khayal H, Salah H. Unilateral transforaminal lumbar interbody fusion (TLIF) using a single cage for treatment of low grade lytic spondylolisthesis. Acta Orthop Belg. 2008 Oct;74(5):667-71.

  PMID: 19058702 BACKGROUND

• Goyal N, Wimberley DW, Hyatt A, Zeiller S, Vaccaro AR, Hilibrand AS, Albert TJ. Radiographic and clinical outcomes after instrumented reduction and transforaminal lumbar interbody fusion of mid and high-grade isthmic spondylolisthesis. J Spinal Disord Tech. 2009 Jul;22(5):321-7. doi: 10.1097/BSD.0b013e318182cdab.

  PMID: 19525786 BACKGROUND

• Houten JK, Post NH, Dryer JW, Errico TJ. Clinical and radiographically/neuroimaging documented outcome in transforaminal lumbar interbody fusion. Neurosurg Focus. 2006 Mar 15;20(3):E8. doi: 10.3171/foc.2006.20.3.9.

  PMID: 16599424 BACKGROUND

• Jagannathan J, Sansur CA, Oskouian RJ Jr, Fu KM, Shaffrey CI. Radiographic restoration of lumbar alignment after transforaminal lumbar interbody fusion. Neurosurgery. 2009 May;64(5):955-63; discussion 963-4. doi: 10.1227/01.NEU.0000343544.77456.46.

  PMID: 19404155 BACKGROUND

• Lauber S, Schulte TL, Liljenqvist U, Halm H, Hackenberg L. Clinical and radiologic 2-4-year results of transforaminal lumbar interbody fusion in degenerative and isthmic spondylolisthesis grades 1 and 2. Spine (Phila Pa 1976). 2006 Jul 1;31(15):1693-8. doi: 10.1097/01.brs.0000224530.08481.4e.

  PMID: 16816765 BACKGROUND

• Rihn JA, Patel R, Makda J, Hong J, Anderson DG, Vaccaro AR, Hilibrand AS, Albert TJ. Complications associated with single-level transforaminal lumbar interbody fusion. Spine J. 2009 Aug;9(8):623-9. doi: 10.1016/j.spinee.2009.04.004. Epub 2009 May 30.

  PMID: 19482519 BACKGROUND

• Rihn JA, Makda J, Hong J, Patel R, Hilibrand AS, Anderson DG, Vaccaro AR, Albert TJ. The use of RhBMP-2 in single-level transforaminal lumbar interbody fusion: a clinical and radiographic analysis. Eur Spine J. 2009 Nov;18(11):1629-36. doi: 10.1007/s00586-009-1046-1. Epub 2009 May 28.

  PMID: 19475434 BACKGROUND

• Sasso RC, LeHuec JC, Shaffrey C; Spine Interbody Research Group. Iliac crest bone graft donor site pain after anterior lumbar interbody fusion: a prospective patient satisfaction outcome assessment. J Spinal Disord Tech. 2005 Feb;18 Suppl:S77-81. doi: 10.1097/01.bsd.0000112045.36255.83.

  PMID: 15699810 BACKGROUND

• Schleicher P, Beth P, Ottenbacher A, Pflugmacher R, Scholz M, Schnake KJ, Haas NP, Kandziora F. Biomechanical evaluation of different asymmetrical posterior stabilization methods for minimally invasive transforaminal lumbar interbody fusion. J Neurosurg Spine. 2008 Oct;9(4):363-71. doi: 10.3171/SPI.2008.9.10.363.

  PMID: 18939923 BACKGROUND

• Xiao Y, Li F, Chen Q. Transforaminal lumbar interbody fusion with one cage and excised local bone. Arch Orthop Trauma Surg. 2010 May;130(5):591-7. doi: 10.1007/s00402-009-0917-6. Epub 2009 Jun 30.

  PMID: 19565252 BACKGROUND

• Xiao YX, Chen QX, Li FC. Unilateral transforaminal lumbar interbody fusion: a review of the technique, indications and graft materials. J Int Med Res. 2009 May-Jun;37(3):908-17. doi: 10.1177/147323000903700337.

  PMID: 19589277 BACKGROUND

• Yan DL, Pei FX, Li J, Soo CL. Comparative study of PILF and TLIF treatment in adult degenerative spondylolisthesis. Eur Spine J. 2008 Oct;17(10):1311-6. doi: 10.1007/s00586-008-0739-1. Epub 2008 Aug 7.

  PMID: 18685873 BACKGROUND

MeSH Terms

Conditions

Joint Diseases; Ankylosis; Pain

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Charles LE HUEC, PUPH

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 14, 2011
• Study Start: May 1, 2011
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: July 1, 2021

Record last verified: 2021-06

Locations

FR (1)