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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Bordeaux
Sponsor:
Collaborator:
Biom'up
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01335243
First received: April 6, 2011
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Degenerative Osteoarthritis
Degenerative Lumbar Vertebra
Procedure: The Transforaminal Lumbar Interbody Fusion (TLIF) surgery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric, Prospective Study of Efficacy and Safety of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Marrow

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • patients' proportion which an intervertebral fusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • NOTION OF TOLERANCE: Frequency and gravity of unwanted Adverse Events linked to the procedure and\or the use of the biomaterial [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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

    O Inflammatory or allergic reaction to the tested product (VS and CRP before inclusion).

    • Non-union turned out and painful
    • Invalidating lumbar pain
    • Infection on the operated site

  • Evaluation of the pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of the pain with an analogical visual scale (EVA)

  • Quality of life evaluation [ Time Frame: 12 years ] [ Designated as safety issue: No ]
    Quality of life evaluation by means of OSWESTRY and SF-36 scales


Estimated Enrollment: 82
Study Start Date: May 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TLIF surgery Procedure: The Transforaminal Lumbar Interbody Fusion (TLIF) surgery
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.

Detailed Description:

This clinical study corresponds to a TLIF surgery using 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.

Biomaterial MATRITM BONE: Device of class III, with marking IT in the indication of arthrodesis. It will be administered during the lumbar interbody fusion's procedure.

The material is a matrix of collagen mineralized containing a homogeneous mixture of collagen cleansed of type I+III and an osseous biphasic substitute HA / TCP. The proportion of both constituents is 90 % of osseous substitute for 10 % of collagen en masse. The collagen is reduced in approximately 1 month and the osseous substitute leads to an osseous reshaping in 6 - 9 months approximately.

The follow up will last 12 months with 2 visits (6 and 12 months after surgery), 2 CT scan slides before inclusion and at 12 months, classical X-rays before inclusion and at 6 and 12 months, questionnaires (visual analogic scale for pain, and quality of life with OSWESTRY and SF36 scales) before inclusion and at 6 and 12 months, and biological exams (CRP/VS, for inflammation) at each visit.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Subject participating in another research including a period of always current exclusion in the pre-inclusion
  • Person placed under protection of justice
  • Severely altered physical and\or psychological Health, which according to, the investigator, can affect to participant's compliance to the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335243

Contacts
Contact: Jean-Charles LE HUEC, PUPH +335 56 79 55 90 jean-charles.lehuec@chu-bordeaux.fr
Contact: Elodie SERIS elodie.seris@chu-bordeaux.fr

Locations
France
Unité d'Orthopédie-Traumatologie rachis II, Pellegrin Recruiting
Bordeaux, France, 33076
Principal Investigator: Jean-Charles LE HUEC, PUPH         
Sub-Investigator: Stéphane AUNOBLE, MD         
Neurosurgery Unit, CHU de Limoges Not yet recruiting
Limoges, France, 87042
Principal Investigator: Mustapha ALI BENALI, MD         
Polyclinique de Francheville Not yet recruiting
Périgueux, France, 24004
Contact: Rachid SADDIKI, MD         
Principal Investigator: Rachid SADDIKI, MD         
Clinique de l'union Not yet recruiting
Saint Jean, France, 31240
Contact: Benoit De GERMAY, MD         
Principal Investigator: Benoit De GERMAY, MD         
Neurosurgery Unit, CHU Toulouse Not yet recruiting
Toulouse, France, 31059
Principal Investigator: Eric SCHMIDT, MD         
Sub-Investigator: Jean-Baptiste DANDINE, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Biom'up
Investigators
Principal Investigator: Jean-Charles LE HUEC, PUPH University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01335243     History of Changes
Other Study ID Numbers: CHUBX 2010/21
Study First Received: April 6, 2011
Last Updated: November 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Orthopedic Procedures
Spine
Interbody fusion
Arthrodesis
Lumbar Vertebrae
CT Scan
Spine balance
Instrumented fusion
Posterior fusion
Degenerative spine
painful

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014