Performance of Inductigraft in Spinal Fusion (APOLLO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Apatech, Inc.
ClinicalTrials.gov Identifier:
NCT01452022
First received: October 5, 2011
Last updated: October 11, 2013
Last verified: October 2011
  Purpose

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 Intervention Phase
Degenerative Disk Disease
Spinal Stenosis of Lumbar Region
Device: Inductigraft
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Apatech, Inc.:

Primary Outcome Measures:
  • Fusion rate [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Assessed by x-ray and CT scan


Secondary Outcome Measures:
  • Fusion rate [ Time Frame: 6 and 24 months after surgery ] [ Designated as safety issue: No ]
    fusion rate at 6 and 24 months by x-ray/CT scan

  • Clinical Outcome Measure - pain [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Assessed by VAS scores

  • Clinical Outcome measure - Quality of Life [ Time Frame: 6,12,and 24 months ] [ Designated as safety issue: No ]
    Oswestry Disability Index

  • Clinical Outcome measure - Quality of Life [ Time Frame: 6,12,and 24 months ] [ Designated as safety issue: No ]
    SF-36 v2 short form, health questionnaire

  • Adverse events [ Time Frame: 0-24 months after surgery ] [ Designated as safety issue: Yes ]
    Assessment of Adverse events


Enrollment: 125
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452022

Locations
Ireland
Beaumont Hospital
Dublin, Ireland, 9
Sponsors and Collaborators
Apatech, Inc.
Investigators
Principal Investigator: Ciaran Bolger Beaumont Hospital, Dublin
  More Information

No publications provided

Responsible Party: Apatech, Inc.
ClinicalTrials.gov Identifier: NCT01452022     History of Changes
Other Study ID Numbers: INDOUS1001
Study First Received: October 5, 2011
Last Updated: October 11, 2013
Health Authority: Denmark: Ethics Committee
Hungary: Institutional Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Ireland: Research Ethics Committee
Spain: Ethics Committee
United Kingdom: Research Ethics Committee

Keywords provided by Apatech, Inc.:
inductigraft
osteoinductive
synthetic bone graft
posterolateral lumbar fusion
post market
lumbar spinal stenosis

Additional relevant MeSH terms:
Spinal Stenosis
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014