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

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ClinicalTrials.gov Identifier: NCT03928041
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Medical Metrics Diagnostics, Inc
Information provided by (Responsible Party):
Invibio Biomaterial Solutions

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 Intervention/treatment Phase
Degenerative Disc Disease Lumbar Spondylolisthesis, Grade 1 Device: Device: EVOS Lumbar Interbody System (EVOS-HA) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 27, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




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)



Information from the National Library of Medicine

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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?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928041


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

Locations
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United States, North Carolina
OrthoCarolina Research Institute Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Amy Roznowski         
United States, Pennsylvania
Thomas Jefferson University Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Tiffany Morrison         
Sponsors and Collaborators
Invibio Biomaterial Solutions
Medical Metrics Diagnostics, Inc
Investigators
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Principal Investigator: Mark Kurd, M.D. Thomas Jefferson University

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Responsible Party: Invibio Biomaterial Solutions
ClinicalTrials.gov Identifier: NCT03928041     History of Changes
Other Study ID Numbers: CES01
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Invibio Biomaterial Solutions:
Lumbar Degenerative Disc Disease
Spondylolisthesis

Additional relevant MeSH terms:
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Spinal Diseases
Intervertebral Disc Degeneration
Spondylolisthesis
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis