Performance of Inductigraft in Spinal Fusion

NCT ID: NCT01452022

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-08-31

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.

Conditions

Degenerative Disk Disease; Spinal Stenosis of Lumbar Region

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inductigraft

open label non randomised to assess performance of synthetic bone graft using the product, Inductigraft, in posterolateral lumbar fusion

Group Type: EXPERIMENTAL

Inductigraft

Intervention Type: DEVICE

Synthetic bone graft

Interventions

Inductigraft

Synthetic bone graft

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apatech, Inc.

INDUSTRY

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ciaran Bolger

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital, Dublin

Locations

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, Dublin, Ireland

Fundacio Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Clinical de Barcelona & Clinical Corachan

Barcelona, , Spain

HGU Gregorio Marañón

Madrid, , Spain

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

Countries

Germany; Hungary; Ireland; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30834972 (View on PubMed)

Other Identifiers

INDOUS1001

Identifier Type: -

Identifier Source: org_study_id