Evaluating a new spinal fusion device for back pain relief

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

This study is testing a new spinal fusion device to see if it can help people with back pain from certain conditions feel better after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Invibio Ltd (Industry-sponsored)
• Locations: 1 site (Lancaster, Pennsylvania)
• Trial ID: NCT04416321 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the PEEK-OPTIMA™ HA Enhanced Keos Lumbar Interbody Fusion Device in patients with degenerative disc disease, spondylolisthesis, and retrolisthesis. It is a prospective, non-comparative, single-center trial that will track clinical, radiographic, and CT outcomes over a 24-month period following surgery. The study will involve 30 patients who have not found relief from conservative treatments and are suitable candidates for transforaminal lumbar interbody fusion surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic degenerative disc disease or related conditions who have not responded to conservative treatments.

Not a fit: Patients with previous spinal surgery at the affected levels or those with severe underlying conditions like tumors or osteoporosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new surgical option for patients suffering from chronic back pain due to degenerative conditions.

How similar studies have performed: Other studies have shown promising results with similar spinal fusion devices, indicating potential for success in this approach.

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.

Where this trial is running

Lancaster, Pennsylvania

• Neurosurgical Associates of Lancaster — Lancaster, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Louis A Marotti, M.D. PhD — Neurosurgical Associates of Lancaster
• Study coordinator: Karen Robson

Conditions Degenerative Disc Disease; Spondylolisthesis; Retrolisthesis; Lumbar Degenerative Disc Disease; retrolisthesis