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

University Hospital of Bordeaux

Status and phase

Completed

Phase 2

Conditions

Degenerative Osteoarthritis

Degenerative Lumbar Vertebra

Treatments

Procedure: The Transforaminal Lumbar Interbody Fusion (TLIF) surgery

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01335243

CHUBX 2010/21

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.