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

June 29, 2021 updated by: University Hospital, Bordeaux

Multicentric, Prospective Study of Efficacy and Safety of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Marrow

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Unité d'Orthopédie-Traumatologie rachis II, Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
Evaluation of the pain
Time Frame: 12 months
Evaluation of the pain with an analogical visual scale (EVA)
12 months
Quality of life evaluation
Time Frame: 12 years
Quality of life evaluation by means of OSWESTRY and SF-36 scales
12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Biom'Up France SAS

Investigators

  • Study Chair: Antoine Bénard, MD, University Hospital, Bordeaux
  • Principal Investigator: Jean-Charles LE HUEC, PUPH, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

June 30, 2015

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

April 6, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimate)

April 14, 2011

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2010/21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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