Clinical trial NCT01452022: Performance of Inductigraft in Spinal Fusion
Official title: A Prospective Open-label Non-randomdised Multi-centre Clinical Study to Evaluate the Performance of Inductigraft in Posterolateral Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disk Disease
Spinal Stenosis of Lumbar Region
Keywords: inductigraft
osteoinductive
synthetic bone graft
posterolateral lumbar fusion
post market
lumbar spinal stenosis
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Apatech, Inc.
First posted: 2011-10-14
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label non-randomised, prospective, post market study to evaluate the performance of Inductigraft (osteoinductive synthetic bone graft) in patients receiving posterolateral lumbar spine fusion through assessment of successful fusion at 12 months post operation using x-rays and CT scans. Quality of life questionnaires also used to assess clinical outcome measures such as pain and quality of life. Patients followed up for 24 months after surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Degenerative Disk Disease (DDD) or lumbar spinal stenosis at one or two continuous spinal level(s), including subjects with spondylolisthesis (i.e. degenerative or isthmic)
* Has failed at least six months of non-operative treatment prior to clinical trial enrolment and is a candidate for spinal fusion surgery over one or two vertebral levels between, and including, L2 to S1 (i.e. second lumbar to first sacral)
* ≥ 18 years old and skeletally mature (epiphyses closed)
* Is, in the Investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow up visits, the filling out of required forms, and have the ability to understand and give written informed consent.

Exclusion Criteria:

* Has diagnosis of symptomatic DDD, spondylolisthesis, or lumbar spinal stenosis at more than two levels
* Has had prior fusion surgery at any lumbar level
* Has systemic infection or infection at the surgical site
* History of significant metabolic bone disease such as osteomalacia, autoimmune disease including rheumatoid arthritis, renal disease, hepatic disease, peripheral vascular disease, insulin dependent diabetes, Paget's disease at the involved spinal level(s) or upper motor neuron disease (positive Babinski sign)
* Has a medical condition that would interfere with post-operative assessments and care (i.e. psychiatric disease, paraplegia, quadriplegia, etc.)
* Is in poor general health or any concurrent disease process that would place the subject in excessive risk to surgery (e.g. significant circulatory, pulmonary problems, or cardiac disease)
* Has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow up
* Is known to be pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the clinical trial
* Is participating in, or has completed within the last 30 days, another investigational clinical trial, which could confound results
* Has had three or more prior decompressive surgeries, or a prior posterior lumbar surgery resulting in significant muscle/ligament morbidity. This does NOT include facet saving techniques such as discectomy, laminotomy, and intradiscal procedures including nucleotomy, IDET procedures or annuloplasty procedures
* Has back or leg pain of unknown cause
* Morbid obesity defined as a Body Mass Index (BMI) ≥ 40
* Non-discogenic or non-stenotic cause of symptoms (e.g. tumour or fracture at the involved level)
* Has a condition or requires post-operative medications that may interfere with bone/soft tissue healing (i.e. oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.), or that effect the rate of bone metabolism unless they have undergone a 14 day wash out period prior to surgery
* Is undergoing treatment for osteoporosis (excluding osteopenia) such that in the Investigator's opinion, spinal instrumentation would be contraindicated
* Is involved in on-going litigation, concerning their medical condition.
* Has a known allergy to silicon.

Primary outcomes:
measure: Fusion rate
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Fusion rate
timeFrame: 6 and 24 months after surgery
measure: Clinical Outcome Measure - pain
timeFrame: 6, 12 and 24 months
measure: Clinical Outcome measure - Quality of Life
timeFrame: 6,12,and 24 months
measure: Clinical Outcome measure - Quality of Life
timeFrame: 6,12,and 24 months
measure: Adverse events
timeFrame: 0-24 months after surgery
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Cologne
country: Germany
facility: University of Cologne
city: München
country: Germany
facility: Ludwig-Maximilians-Universität München
city: Budapest
country: Hungary
facility: Buda Health Center
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Barcelona
country: Spain
facility: Fundacio Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinical de Barcelona & Clinical Corachan
city: Madrid
country: Spain
facility: HGU Gregorio Marañón
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Nottingham
country: United Kingdom
facility: Queens Medical Centre
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Southhampton
country: United Kingdom
facility: Shire Southhampton Hospital
city: Tauton
country: United Kingdom
facility: Musgrove Park Hospital
Study officials:
affiliation: Beaumont Hospital, Dublin
name: Ciaran Bolger
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bolger C, Jones D, Czop S. Evaluation of an increased strut porosity silicate-substituted calcium phosphate, SiCaP EP, as a synthetic bone graft substitute in spinal fusion surgery: a prospective, open-label study. Eur Spine J. 2019 Jul;28(7):1733-1742. doi: 10.1007/s00586-019-05926-1. Epub 2019 Mar 5.