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

NCT03928041 | Completed FDA Device

• 1 other identifier: CES01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Degenerative Disc Disease Lumbar; Spondylolisthesis, Grade 1

Keywords

Lumbar Degenerative Disc Disease; Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To measure how much pain the subject is in according to a pain scale - 0-10

  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

  pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively

• Functional Impairment

  pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively

Study Arms (1)

single prospective study

OTHER

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)

Interventions

Device: EVOS Lumbar Interbody System (EVOS-HA) DEVICE

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.

single prospective study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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?

Sponsors & Collaborators

• Invibio Ltd: lead
• Medical Metrics Diagnostics, Inc: collaborator

Study Sites (2)

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Spondylolisthesis; Lymphoma, Follicular; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mark Kurd, M.D.

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will be recruited and receive the EVOS-HA prospectively.

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 25, 2019
• Study Start: June 27, 2019
• Primary Completion: May 22, 2023
• Study Completion: September 25, 2023
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)