Clinical trial NCT01335243: Efficacy and Safety Study of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Bone Marrow
Official title: Multicentric, Prospective Study of Efficacy and Safety of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Marrow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Biom'Up France SAS
First posted: 2011-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: patients' proportion which an intervertebral fusion
timeFrame: 12 months
Secondary outcomes:
measure: NOTION OF TOLERANCE: Frequency and gravity of unwanted Adverse Events linked to the procedure and\or the use of the biomaterial
timeFrame: 12 months
measure: Evaluation of the pain
timeFrame: 12 months
measure: Quality of life evaluation
timeFrame: 12 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Unité d'Orthopédie-Traumatologie rachis II, Pellegrin
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-Charles LE HUEC, PUPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Antoine BENARD, MD
role: STUDY_CHAIR
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