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

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04416321
• Other study ID #: KEOS01
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: January 2026

Study information

• Verified date: September 2023
• Source: Invibio Ltd
• Contact: Karen Robson
• Phone: +44 7765 220492
• Email: karen.robson[@]invibio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Retrolisthesis
• Spondylolisthesis

Intervention

Device:
• Surgery with the Keos Lumbar Interbody Fusion Device
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

Locations

Country	Name	City	State
United States	Neurosurgical Associates of Lancaster	Lancaster	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Invibio Ltd	Keos LLC, Medical Metrics Diagnostics, Inc, Technomics Research, Viedoc Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interbody fusion rate	Interbody fusion will be graded along the superior and inferior interfaces separately in 25% increments	6 months post - operatively
Secondary	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)	6 weeks, 3, 6, 12 and 24 months post operatively
Secondary	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.	pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively
Secondary	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)	pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively