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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 : July 19, 2021
Sponsor:
Collaborator:
Medical Metrics Diagnostics, Inc
Information provided by (Responsible Party):
Invibio Ltd

Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date July 19, 2021
Actual Study Start Date  ICMJE June 27, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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)
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE
  • Degenerative Disc Disease Lumbar
  • Spondylolisthesis, Grade 1
Intervention  ICMJE 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.
Study Arms  ICMJE single prospective study
All subjects who are entered into this trial will receive the EVOS Lumbar Interbody System (EVOS- HA).
Intervention: Device: Device: EVOS Lumbar Interbody System (EVOS-HA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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?
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen Robson +44 7765220492 karen.robson@invibo.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928041
Other Study ID Numbers  ICMJE CES01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Invibio Ltd
Study Sponsor  ICMJE Invibio Ltd
Collaborators  ICMJE Medical Metrics Diagnostics, Inc
Investigators  ICMJE
Principal Investigator: Mark Kurd, M.D. Thomas Jefferson University
PRS Account Invibio Ltd
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP