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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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?

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03928041
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Invibio Biomaterial Solutions
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mark Kurd, M.D.
Principal Investigator Affiliation Thomas Jefferson University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1
Additional Details

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.

Arms & Interventions

Arms

Other: single prospective study

All subjects who are entered into this trial will receive the EVOS Lumbar Interbody System (EVOS- HA).

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

OrthoCarolina Research Institute, Charlotte, North Carolina

Status

Recruiting

Address

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207

Site Contact

Amy Roznowski

[email protected]

+44 7765220492

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

Site Contact

Tiffany Morrison

[email protected]

+44 7765220492