Efficacy and Safety Study of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous … (NCT01335243) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety Study of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Bone Marrow
France32 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 alwa…
What they're measuring
1
patients' proportion which an intervertebral fusion