A Phase 2 interventional study of The Transforaminal Lumbar Interbody Fusion (TLIF) surgery in Degenerative Osteoarthritis and Degenerative Lumbar Vertebra, sponsored by University Hospital, Bordeaux. Terminated at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by University Hospital, Bordeaux · Phase 2, Interventional, and Treatment
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.
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's enrollment of 32 is below the median of 60 across 470 interventional studies indexed under Joint Diseases.
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Exclusion Criteria:
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.
patients' proportion which an intervertebral fusion
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.
Time frame: 12 months
NOTION OF TOLERANCE: Frequency and gravity of unwanted Adverse Events linked to the procedure and\or the use of the biomaterial
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
Time frame: 12 months
Evaluation of the pain
Evaluation of the pain with an analogical visual scale (EVA)
Time frame: 12 months
Quality of life evaluation
Quality of life evaluation by means of OSWESTRY and SF-36 scales
Time frame: 12 years
This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux