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Performance of Inductigraft in Spinal Fusion (APOLLO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01452022
Recruitment Status : Completed
First Posted : October 14, 2011
Last Update Posted : April 5, 2017
Apatech, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Degenerative Disk Disease Spinal Stenosis of Lumbar Region Device: Inductigraft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Open-label Non-randomdised Multi-centre Clinical Study to Evaluate the Performance of Inductigraft in Posterolateral Fusion
Study Start Date : October 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Inductigraft
open label non randomised to assess performance of synthetic bone graft using the product, Inductigraft, in posterolateral lumbar fusion
Device: Inductigraft
Synthetic bone graft

Primary Outcome Measures :
  1. Fusion rate [ Time Frame: 12 months after surgery ]
    Assessed by x-ray and CT scan

Secondary Outcome Measures :
  1. Fusion rate [ Time Frame: 6 and 24 months after surgery ]
    fusion rate at 6 and 24 months by x-ray/CT scan

  2. Clinical Outcome Measure - pain [ Time Frame: 6, 12 and 24 months ]
    Assessed by VAS scores

  3. Clinical Outcome measure - Quality of Life [ Time Frame: 6,12,and 24 months ]
    Oswestry Disability Index

  4. Clinical Outcome measure - Quality of Life [ Time Frame: 6,12,and 24 months ]
    SF-36 v2 short form, health questionnaire

  5. Adverse events [ Time Frame: 0-24 months after surgery ]
    Assessment of Adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01452022

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Universitätsklinikum Bonn
Bonn, Germany
University of Cologne
Cologne, Germany
Ludwig-Maximilians-Universität München
München, Germany
Buda Health Center
Budapest, Hungary
University of Debrecen
Debrecen, Hungary
Beaumont Hospital
Dublin, Ireland, 9
Fundacio Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinical de Barcelona & Clinical Corachan
Barcelona, Spain
HGU Gregorio Marañón
Madrid, Spain
United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Queens Medical Centre
Nottingham, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Salford Royal NHS Foundation Trust
Salford, United Kingdom
Shire Southhampton Hospital
Southhampton, United Kingdom
Musgrove Park Hospital
Tauton, United Kingdom
Sponsors and Collaborators
Baxter Healthcare Corporation
Apatech, Inc.
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Principal Investigator: Ciaran Bolger Beaumont Hospital, Dublin
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Baxter Healthcare Corporation Identifier: NCT01452022    
Other Study ID Numbers: INDOUS1001
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by Baxter Healthcare Corporation:
synthetic bone graft
posterolateral lumbar fusion
post market
lumbar spinal stenosis
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases