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

Invibio

Status: Enrolling

Conditions: Degenerative Disc Disease; Retrolisthesis; Spondylolisthesis

Treatments: Device: Surgery with the Keos Lumbar Interbody Fusion Device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04416321

KEOS01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Device

Other group

Description:

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

Treatment:

Device: Surgery with the Keos Lumbar Interbody Fusion Device