Performance of Inductigraft in Spinal Fusion (APOLLO)

April 4, 2017 updated by: Baxter Healthcare Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Fundació Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Hospital Clinical de Barcelona & Clinical Corachan
      • Madrid, Spain
        • HGU Gregorio Marañón
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fusion rate
Time Frame: 12 months after surgery
Assessed by x-ray and CT scan
12 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fusion rate
Time Frame: 6 and 24 months after surgery
fusion rate at 6 and 24 months by x-ray/CT scan
6 and 24 months after surgery
Clinical Outcome Measure - pain
Time Frame: 6, 12 and 24 months
Assessed by VAS scores
6, 12 and 24 months
Clinical Outcome measure - Quality of Life
Time Frame: 6,12,and 24 months
Oswestry Disability Index
6,12,and 24 months
Clinical Outcome measure - Quality of Life
Time Frame: 6,12,and 24 months
SF-36 v2 short form, health questionnaire
6,12,and 24 months
Adverse events
Time Frame: 0-24 months after surgery
Assessment of Adverse events
0-24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxter Healthcare Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Apatech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ciaran Bolger, Beaumont Hospital, Dublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INDOUS1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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