Performance of Inductigraft in Spinal Fusion

Not Applicable

Completed

• Conditions: Degenerative Disk Disease; Spinal Stenosis of Lumbar Region
• Interventions: Device: Inductigraft

• Registration Number: NCT01452022
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-14
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inductigraft	Inductigraft	open label non randomised to assess performance of synthetic bone graft using the product, Inductigraft, in posterolateral lumbar fusion

Primary Outcome Measures

Name	Time	Method
Fusion rate	12 months after surgery	Assessed by x-ray and CT scan

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome Measure - pain	6, 12 and 24 months	Assessed by VAS scores
Adverse events	0-24 months after surgery	Assessment of Adverse events
Clinical Outcome measure - Quality of Life	6,12,and 24 months	SF-36 v2 short form, health questionnaire
Fusion rate	6 and 24 months after surgery	fusion rate at 6 and 24 months by x-ray/CT scan

Trial Locations

Locations (15)

Buda Health Center; 🇭🇺 Budapest, Hungary

Hospital Clinical de Barcelona & Clinical Corachan; 🇪🇸 Barcelona, Spain

Fundacio Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom

Queens Medical Centre; 🇬🇧 Nottingham, United Kingdom

HGU Gregorio Marañón; 🇪🇸 Madrid, Spain

Royal Preston Hospital; 🇬🇧 Preston, United Kingdom

Shire Southhampton Hospital; 🇬🇧 Southhampton, United Kingdom

Musgrove Park Hospital; 🇬🇧 Tauton, United Kingdom

Salford Royal NHS Foundation Trust; 🇬🇧 Salford, United Kingdom

University of Debrecen; 🇭🇺 Debrecen, Hungary

University of Cologne; 🇩🇪 Cologne, Germany

Beaumont Hospital; 🇮🇪 Dublin, Ireland

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Ludwig-Maximilians-Universität München; 🇩🇪 München, Germany