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A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.

Primary Purpose

Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Surgery with the Keos Lumbar Interbody Fusion Device

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Lumbar Degenerative Disc Disease, Spondylolisthesis, retrolisthesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged 18 years of age or older.
Primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1), or retrolisthesis, at one or two contiguous levels from L2 to S1.
Have discogenic back pain.
Suitable for transforaminal lumbar interbody fusion (TLIF) surgery.
Indicated for surgical treatment with the Keos Lumbar IBFD with autologous bone graft.
Completed at least 6 months of conservative non-operative treatment.
Female subjects of childbearing age must have a negative pregnancy test.
Able to understand this clinical study, co-operate with procedures.
Able to give voluntary, written informed consent to participate.

Exclusion Criteria:

Not undergone previous spinal surgery at the affected disc level(s).
Evidence of tumour and/or malignant disease.
Known osteoporosis or severe osteopenia.
Known rheumatoid arthritis, ankylosing spondylitis or who are immunocompromised.
Known allergy to the material used in the instrumentation.
Evidence of an active infection.
Any conditions outlined as contraindicated in the Instructions for Use.
Receiving any drug treatment that may affect bone metabolism.
Female subjects who are pregnant or lactating.
Current smokers or have stopped smoking less than 6 months ago.
Known drug or alcohol abusers.
Currently enrolled in a clinical study.

Sites / Locations

Neurosurgical Associates of LancasterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Device

Arm Description

All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device.

Outcomes

Primary Outcome Measures

Interbody fusion rate

Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments

Secondary Outcome Measures

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)

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 summarised into Physical and Mental Health Composite Scores (PCS & MCS) and range from 0-100. 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

Questionnaire ODI (Oswestry Disability Index) - disability questionnaire used to assess functional impairment of the patient. Regarding lifting, ability to walk, sit, stand, sleep, travel and graded by score of 0-100 (0= no disability and 100= maximum disability possible)

Full Information

NCT ID

NCT04416321

First Posted

June 2, 2020

Last Updated

September 26, 2023

Sponsor

Invibio Ltd

Collaborators

Keos LLC, Medical Metrics Diagnostics, Inc, Technomics Research, Viedoc Technologies

1. Study Identification

Unique Protocol Identification Number

NCT04416321

Brief Title

A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.

Official Title

A Prospective, Non-comparative, Single-centre, Post-market Clinical Study to Evaluate the Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages for the Treatment of Degenerative Disc Disease in the Lumbar Spine

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

January 2026 (Anticipated)

Study Completion Date

January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Invibio Ltd

Collaborators

Keos LLC, Medical Metrics Diagnostics, Inc, Technomics Research, Viedoc Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.

Detailed Description

This prospective, non-comparative, single-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA ™ HA Enhanced Keos Lumbar Interbody Fusion Device in patients suffering from degenerative disc disease, spondylolisthesis and retrolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. One centre will be involved in the recruitment of 30 patients the clinic involved will focus on this type of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis

Keywords

Lumbar Degenerative Disc Disease, Spondylolisthesis, retrolisthesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Device

Arm Type

Other

Arm Description

All subjects who are entered into this trial will receive the Keos Lumbar Interbody Fusion Device.

Intervention Type

Device

Intervention Name(s)

Surgery with the Keos Lumbar Interbody Fusion Device

Intervention Description

All subjects will received the Keos Lumbar Interbody Fusion Device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease, spondylolisthesis and retrolisthesis

Primary Outcome Measure Information:

Title

Interbody fusion rate

Description

Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments

Time Frame

6 months post - operatively

Secondary Outcome Measure Information:

Title

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

Description

Visual analogue scale for back and leg 0-10 cm (no pain - worst possible pain)

Time Frame

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

Title

To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12

Description

Time Frame

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

Title

Functional Impairment

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 18 years of age or older. Primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1), or retrolisthesis, at one or two contiguous levels from L2 to S1. Have discogenic back pain. Suitable for transforaminal lumbar interbody fusion (TLIF) surgery. Indicated for surgical treatment with the Keos Lumbar IBFD with autologous bone graft. Completed at least 6 months of conservative non-operative treatment. Female subjects of childbearing age must have a negative pregnancy test. Able to understand this clinical study, co-operate with procedures. Able to give voluntary, written informed consent to participate. Exclusion Criteria: Not undergone previous spinal surgery at the affected disc level(s). Evidence of tumour and/or malignant disease. Known osteoporosis or severe osteopenia. Known rheumatoid arthritis, ankylosing spondylitis or who are immunocompromised. Known allergy to the material used in the instrumentation. Evidence of an active infection. Any conditions outlined as contraindicated in the Instructions for Use. Receiving any drug treatment that may affect bone metabolism. Female subjects who are pregnant or lactating. Current smokers or have stopped smoking less than 6 months ago. Known drug or alcohol abusers. Currently enrolled in a clinical study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karen Robson

Phone

+44 7765 220492

karen.robson@invibio.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sheryl O'Farrell

Phone

+44 7880024484

sheryl.ofarrell@invibio.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis A Marotti, M.D. PhD

Organizational Affiliation

Neurosurgical Associates of Lancaster

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neurosurgical Associates of Lancaster

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17601

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nichole Beaty

Phone

717-358-0800

Ext

215

nbeaty@argiresmarotti.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.

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