Efficacy and Safety Study of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Bone Marrow (MatriBone)
Recruitment status was: Active, not recruiting
|Degenerative Osteoarthritis Degenerative Lumbar Vertebra||Procedure: The Transforaminal Lumbar Interbody Fusion (TLIF) surgery||Phase 2|
|Study Design:||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|
- patients' proportion which an intervertebral fusion [ Time Frame: 12 months ]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.
- 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 ]
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 ]Evaluation of the pain with an analogical visual scale (EVA)
- Quality of life evaluation [ Time Frame: 12 years ]Quality of life evaluation by means of OSWESTRY and SF-36 scales
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335243
|Unité d'Orthopédie-Traumatologie rachis II, Pellegrin|
|Bordeaux, France, 33076|
|Principal Investigator:||Jean-Charles LE HUEC, PUPH||University Hospital, Bordeaux|
|Study Chair:||Antoine BENARD, MD||University Hospital, Bordeaux|