ACTIVE_NOT_RECRUITING

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

Conditions

Degenerative Disc Disease Spondylolisthesis Retrolisthesis Lumbar Degenerative Disc Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-07-01

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04416321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Louis A Marotti, M.D. PhD

PRINCIPAL_INVESTIGATOR

Neurosurgical Associates of Lancaster

Study Locations (Sites)

Neurosurgical Associates of Lancaster

Lancaster, Pennsylvania, 17601

United States

Collaborators and Investigators

Sponsor: Invibio Ltd

Louis A Marotti, M.D. PhD, PRINCIPAL_INVESTIGATOR, Neurosurgical Associates of Lancaster

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-01

Study Completion Date2026-01

Study Record Updates

Study Start Date2021-07-01

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

Lumbar Degenerative Disc Disease
Spondylolisthesis
retrolisthesis

Additional Relevant MeSH Terms

Degenerative Disc Disease
Spondylolisthesis
Retrolisthesis