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

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

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.

Study Overview

• Status: Completed
• Conditions: Spondylolisthesis, Grade 1; Degenerative Disc Disease Lumbar
• Intervention / Treatment: Device: Device: EVOS Lumbar Interbody System (EVOS-HA)

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: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interbody fusion rate	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.	6 months post - operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure how much pain the subject is in according to a pain scale - 0-10	Visual Analogue Scale for back and leg - 0 - 10 cm (no pain - worst possible pain)	6 weeks, 3, 6, 12 and 24 months post operatively
To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12	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.	pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
Functional Impairment	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)	pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively

Collaborators and Investigators

• Sponsor: Invibio Ltd
• Collaborators: Medical Metrics Diagnostics, Inc
• Investigators: Principal Investigator: Mark Kurd, M.D., Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Spondylolisthesis; Lumbar Degenerative Disc Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: CES01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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