Performance of Inductigraft in Spinal Fusion (APOLLO)

A Prospective Open-label Non-randomdised Multi-centre Clinical Study to Evaluate the Performance of Inductigraft in Posterolateral Fusion

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.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis of Lumbar Region; Degenerative Disk Disease
• Intervention / Treatment: Device: Inductigraft

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany
    • Universitätsklinikum Bonn
  • Cologne, Germany
    • University of Cologne
  • München, Germany
    • Ludwig-Maximilians-Universität München
• Hungary
  • Budapest, Hungary
    • Buda Health Center
  • Debrecen, Hungary
    • University of Debrecen
• Ireland
  • Dublin, Ireland, 9
    • Beaumont Hospital
• Spain
  • Barcelona, Spain
    • Fundacio Hospital Universitari Vall d'Hebron
  • Barcelona, Spain
    • Hospital Clinical de Barcelona & Clinical Corachan
  • Madrid, Spain
    • Hgu Gregorio Maranon
• United Kingdom
  • Cardiff, United Kingdom
    • University Hospital of Wales
  • Nottingham, United Kingdom
    • Queens Medical Centre
  • Preston, United Kingdom
    • Royal Preston Hospital
  • Salford, United Kingdom
    • Salford Royal NHS Foundation Trust
  • Southhampton, United Kingdom
    • Shire Southhampton Hospital
  • Tauton, United Kingdom
    • Musgrove Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion rate	Assessed by x-ray and CT scan	12 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Apatech, Inc.
• Investigators: Principal Investigator: Ciaran Bolger, Beaumont Hospital, Dublin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 5, 2011
• First Submitted That Met QC Criteria: October 12, 2011
• First Posted (Estimate): October 14, 2011

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: posterolateral lumbar fusion; lumbar spinal stenosis; inductigraft; osteoinductive; synthetic bone graft; post market
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Spinal Stenosis
• Other Study ID Numbers: INDOUS1001