A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine
- Conditions
- Degenerative Disc Disease LumbarSpondylolisthesis, Grade 1
- Registration Number
- NCT03928041
- Lead Sponsor
- Invibio Ltd
- Brief Summary
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.
- Detailed Description
This prospective, non-comparative, multi-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA™ HA Enhance Interbody Cages System - EVOS- HA in patients suffering from degenerative disc disease and spondylolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. Two centers will be involved in the recruitment of 30 patients. All patients will be drawn from clinics which focus on this type of treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- Is the subject aged 18 years of age or older and skeletally mature?
- Does the subject have a primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1) at one or two contiguous levels from L2 to S1?
- Does the subject have discogenic back pain with degeneration of the disc confirmed by medical history, radiographic examination and MRI (MRI must be obtained within the 6 months prior to subject surgery and radiographs obtained within 3 months prior to subject surgery)?
- Is the subject judged by the Investigator to be suitable for transforaminal lumbar interbody fusion (TLIF) surgery based on their medical history?
- Is the subject indicated for surgical treatment with the EVOS Lumbar Interbody System with autologous bone graft?
- Has the subject completed at least 6 months of conservative non-operative treatment without obtaining adequate symptomatic relief?
- If the subject is female and of childbearing age, do they have a negative pregnancy test (by Beta HCG qualitative analysis), or do they have a history of a surgical sterilisation, or a history of no menses in the past twelve months?
- Is the subject, in the opinion of the Investigator, able to understand this clinical study, co-operate with the procedures and are they willing to return to the hospital for all the required post-operative follow-ups?
- Is the subject able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained?
- Has the subject undergone previous spinal surgery at the affected disc level(s), excluding discectomy and laminectomy procedures?
- Does the subject have evidence of tumour and/or malignant disease with resultant life expectancy of less than two years?
- Does the subject have known osteoporosis or severe osteopenia as determined by the Investigator?
- Does the subject have rheumatoid arthritis, ankylosing spondylitis or are they immunocompromised?
- Does the subject have a known allergy to the material used in the instrumentation?
- Does the subject have evidence of an active infection and/or do they have any condition that would compromise their participation and follow-up in this clinical study?
- Is the subject receiving any drug treatment that may affect bone metabolism?
- If the subject is female, are they pregnant or lactating?
- Is the subject a current smoker, or have they stopped smoking less than 6 months ago?
- Is the subject a known drug or alcohol abuser or do they have a baseline opioid use greater than 30 mg of morphine equivalent/day or do they have psychological disorders that could affect follow-up care or treatment outcomes?
- Is the subject currently enrolled in a clinical study?
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Interbody fusion rate 6 months post - operatively Interbody fusion will be graded in accordance with Cook et al. 2004 where bridging bone is graded along the superior and inferior interfaces separately in 25% increments.
- Secondary Outcome Measures
Name Time Method To measure how much pain the subject is in according to a pain scale - 0-10 6 weeks, 3, 6, 12 and 24 months post operatively Visual Analogue Scale for back and leg - 0 - 10 cm (no pain - worst possible pain)
To measure the Quality of Life of the subject according to a set list of questions: Questionnaire SF-12 pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively 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 summarized into Physical and Mental Health Composite Scores (PCS \& MCS) and range from 0 to 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.
Functional Impairment pre-operatively, 6 weeks, 3, 6, 12 and 24 months post operatively Questionnaire ODI ( Oswestry Disability Index) - disability questionnaire uses to assess functional impairment of the patient. Regarding lifting, ability to walk, sit, stand sleep, travel graded by score of 0-100 (0 = no disability and 100- maximum disability possible)
Trial Locations
- Locations (2)
OrthoCarolina Research Institute
🇺🇸Charlotte, North Carolina, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States