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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine

Clinicaltrials.gov identifier NCT03928041

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted May 28, 2020

Study Description

Brief summary:

The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.

  • Condition or Disease:Degenerative Disc Disease Lumbar
    Spondylolisthesis, Grade 1
  • Intervention/Treatment: Device: Device: EVOS Lumbar Interbody System (EVOS-HA)
  • Phase: N/A
Detailed Description

This prospective, non-comparative, multi-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA™ HA Enhance Interbody Cages System - EVOS- HA in patients suffering from degenerative disc disease and spondylolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. Two centers will be involved in the recruitment of 30 patients. All patients will be drawn from clinics which focus on this type of treatment.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Intervention Model: Sequential Assignment
  • Intervention Model Description: All subjects will be recruited and receive the EVOS-HA prospectively.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Prospective, Non-comparative, Multi-center, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease and Spondylolisthesis in the Lumbar Spine
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: October 2022
Arms and interventions
Arm Intervention/treatment
Other: single prospective study
All subjects who are entered into this trial will receive the EVOS Lumbar Interbody System (EVOS- HA).
Device: Device: EVOS Lumbar Interbody System (EVOS-HA)
All subjects will receive the EVOS Lumbar Interbody System (EVOS-HA) device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease and spondylolisthesis.
Outcome Measures
  • Primary Outcome Measures: 1. Interbody fusion rate [ Time Frame: 6 months post - operatively ]
    Interbody fusion will be graded in accordance with Cook et al. 2004 where bridging bone is graded along the superior and inferior interfaces separately in 25% increments.
  • Secondary Outcome Measures: 1. To measure how much pain the subject is in according to a pain scale - 0-10 [ Time Frame: 6 weeks, 3, 6, 12 and 24 months post operatively ]
    Visual Analogue Scale for back and leg - 0 - 10 cm (no pain - worst possible pain)
  • 2. To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12 [ Time Frame: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively ]
    Questionnaire SF-12 collection of questions health related to assess vitality, physical functioning, bodily pain, general health perceptions, emotional and physical functioning, social and mental health. Patients will pick from a set list of answers for each health related question. The responses on each item are scored and summarized into Physical and Mental Health Composite Scores (PCS & MCS) and range from 0 to 100. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
  • 3. Functional Impairment [ Time Frame: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively ]
    Questionnaire ODI ( Oswestry Disability Index) - disability questionnaire uses to assess functional impairment of the patient. Regarding lifting, ability to walk, sit, stand sleep, travel graded by score of 0-100 (0 = no disability and 100- maximum disability possible)
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Is the subject aged 18 years of age or older and skeletally mature?

- Does the subject have a primary diagnosis of symptomatic degenerative disc disease
(DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1)
at one or two contiguous levels from L2 to S1?

- Does the subject have discogenic back pain with degeneration of the disc confirmed by
medical history, radiographic examination and MRI (MRI must be obtained within the 6
months prior to subject surgery and radiographs obtained within 3 months prior to
subject surgery)?

- Is the subject judged by the Investigator to be suitable for transforaminal lumbar
interbody fusion (TLIF) surgery based on their medical history?

- Is the subject indicated for surgical treatment with the EVOS Lumbar Interbody System
with autologous bone graft?

- Has the subject completed at least 6 months of conservative non-operative treatment
without obtaining adequate symptomatic relief?

- If the subject is female and of childbearing age, do they have a negative pregnancy
test (by Beta HCG qualitative analysis), or do they have a history of a surgical
sterilisation, or a history of no menses in the past twelve months?

- Is the subject, in the opinion of the Investigator, able to understand this clinical
study, co-operate with the procedures and are they willing to return to the hospital
for all the required post-operative follow-ups?

- Is the subject able to give voluntary, written informed consent to participate in this
clinical study and from whom consent has been obtained?

Exclusion Criteria:

- Has the subject undergone previous spinal surgery at the affected disc level(s),
excluding discectomy and laminectomy procedures?

- Does the subject have evidence of tumour and/or malignant disease with resultant life
expectancy of less than two years?

- Does the subject have known osteoporosis or severe osteopenia as determined by the
Investigator?

- Does the subject have rheumatoid arthritis, ankylosing spondylitis or are they
immunocompromised?

- Does the subject have a known allergy to the material used in the instrumentation?

- Does the subject have evidence of an active infection and/or do they have any
condition that would compromise their participation and follow-up in this clinical
study?

- Is the subject receiving any drug treatment that may affect bone metabolism?

- If the subject is female, are they pregnant or lactating?

- Is the subject a current smoker, or have they stopped smoking less than 6 months ago?

- Is the subject a known drug or alcohol abuser or do they have a baseline opioid use
greater than 30 mg of morphine equivalent/day or do they have psychological disorders
that could affect follow-up care or treatment outcomes?

- Is the subject currently enrolled in a clinical study?

Contacts and Locations
Contacts

Contact: Karen Robson +44 7765220492 karen.robson@invibo.com

Locations

United States, North Carolina
OrthoCarolina Research Institute
Charlotte

United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia

Sponsors and Collaborators

Invibio Ltd

Medical Metrics Diagnostics, Inc

Investigators

Principal Investigator: Mark Kurd, M.D. Thomas Jefferson University

More Information
  • Responsible Party: Invibio Ltd
  • ClinicalTrials.gov Identifier: NCT03928041 History of Changes
  • Other Study ID Numbers: CES01
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: May 28, 2020
  • Last Verified: May 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Invibio Ltd: Lumbar Degenerative Disc Disease Spondylolisthesis
  • Additional relevant MeSH terms: Intervertebral Disc Degeneration Spondylolisthesis