Clinical trial NCT04416321: 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
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Spondylolisthesis
Retrolisthesis
Keywords: Lumbar Degenerative Disc Disease
Spondylolisthesis
retrolisthesis
Lead sponsor: Invibio Ltd
Sponsor class: INDUSTRY
Collaborators: name: Keos LLC
name: Medical Metrics Diagnostics, Inc
name: Technomics Research
name: Viedoc Technologies
First posted: 2020-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects recruited and will receive the Keos Lumbar Interbody Fusion Device
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years of age or older.
2. 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.
3. Have discogenic back pain.
4. Suitable for transforaminal lumbar interbody fusion (TLIF) surgery.
5. Indicated for surgical treatment with the Keos Lumbar IBFD with autologous bone graft.
6. Completed at least 6 months of conservative non-operative treatment.
7. Female subjects of childbearing age must have a negative pregnancy test.
8. Able to understand this clinical study, co-operate with procedures.
9. Able to give voluntary, written informed consent to participate.

Exclusion Criteria:

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

Primary outcomes:
measure: Interbody fusion rate
timeFrame: 6 months post - operatively
Secondary outcomes:
measure: To measure how much pain the subject is in according to a pain scale 0-10
timeFrame: 6 weeks, 3, 6, 12 and 24 months post operatively
measure: To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12
timeFrame: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
measure: Functional Impairment
timeFrame: pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Neurosurgical Associates of Lancaster
state: Pennsylvania
Study officials:
affiliation: Neurosurgical Associates of Lancaster
name: Louis A Marotti, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References: