Performance of Inductigraft in Spinal Fusion

Degenerative Disk Disease Clinical Trial

— APOLLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452022
• Other study ID #: INDOUS1001
• Status: Completed
• Phase: N/A
• First received: October 5, 2011
• Last updated: April 4, 2017
• Start date: October 2011
• Est. completion date: August 2015

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disk Disease
• Intervertebral Disc Degeneration
• Spinal Stenosis
• Spinal Stenosis of Lumbar Region

Intervention

Device:
• Inductigraft
Synthetic bone graft

Locations

Country	Name	City	State
Germany	Universitätsklinikum Bonn	Bonn
Germany	University of Cologne	Cologne
Germany	Ludwig-Maximilians-Universität München	München
Hungary	Buda Health Center	Budapest
Hungary	University of Debrecen	Debrecen
Ireland	Beaumont Hospital	Dublin
Spain	Fundacio Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Clinical de Barcelona & Clinical Corachan	Barcelona
Spain	HGU Gregorio Marañón	Madrid
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

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Apatech, Inc.

Countries where clinical trial is conducted

Germany,  Hungary,  Ireland,  Spain,  United Kingdom, 

Outcome

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