Degenerative Disc Disease, Grade 1 Spondylolisthesis, Retrolisthesis, Symptomatic Cervical Disc Disease
Conditions
Keywords
Retrolisthesis, Grade 1 Spondyloisthesis, Degenerative Disc Disease, Symptomatic Cervical Disc Disease
Brief summary
This is a Retrospective, Observational Multi-Center study, utilizing patients diagnosed with up to a Grade1 spondylolisthesis or retrolisthesis or symptomatic degenerative disc disease and treated with STALIF® C, or M, Ti and/or FLX implants at one or two levels.
Detailed description
The study is intended to codify the performance of the STALIF family of products. Its design is to provide retrospective data derived from the patient's medical and surgical chart and prospectively assess the treating surgeon and patient on their level of satisfaction post-operative up to present. All subjects who sign an informed consent will be included in the prospective data collection via chart review at the individual investigational sites. The prospective data will come from subjects who complete the designated patient assessments as well as the treating surgeon. The data collection period will include surgeries performed between 2014 to present. The analysis will support the safety profile of the product family and allow for comparison to the available literature as well as between device types (Ti versus FLX). Furthermore, data from this study will support post-market surveillance requirements for the STALIF family of products.
Interventions
DEVICESTALIF®
STALIF® C, or M, Ti or FLX
Sponsors
Centinel Spine
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with up to a Grade1 spondylolisthesis or retrolisthesis or degenerative disc disease of the cervical or lumbar spine at time of surgery. * 2 levels, between: * C: C2-T1 (neck) * M: L2-S1 (low back) * Skeletally mature at the time of surgery with clinical and radiological evidence of degenerative disc disease of the cervical or lumbar spine.
Exclusion criteria
* Subject who had surgery with the STALIF devices at more than 2-levels. * In the Investigator's opinion, the subject diagnosed with a disease or condition, which precludes the possibility of healing at the time of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) Questionnaire | Change from baseline at 24 months | Assessing low back disability. Questionnaire consists of 10 sections with 6 possible choices in each section. Patient to choose 1 answer that best describes his/her ability to manage everyday activities. The questions weighted and summarized providing physical and mental health scores (PCS and MCS) ranging from 0 to 100. High scores indicating worse outcome and lower scores indicating better outcomes. |
| Neck Disability Index (NDI) | Change from baseline at 24 months | Assessing cervical neck disability questionnaire. Questionnaire consists of 10 sections with 6 possible choices in each section. Patient to choose 1 answer that best describes his/her ability to manage everyday life activities. The questions weighted and summarized providing physical and mental health scores (PCS and MCS) and range from 0 to 100. High scores indicating worse outcome and lower scores indicating better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Day of surgery to 12 months | Adverse events |
| Patient Self Satisfaction Survey | Post-op at 24 months | Self reported patient satisfaction survey consisting of 4 questions with 5 possible choices in each section. Patient to select one answer in each section. Scoring range from 0 to 100. Higher score extremely satisfied and lower score equals extremely dissatisfied. |
| Quality of Lift Questionnaire (SF-12) Prospective Arm of Study | Post-op at 24 months. | SF-12 consists of 12 questions. Responses scored and summarized into physical and mental health composite scores (PCS and MCS) and range from 0 to 100. Higher score indicating better health. Score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
| Surgeon Self Satisfaction Survey | Post-op at 24 months | Surgeon Self Satisfaction Survey consists of 5 questions with 5 possible choices in each section. Surgeon to select one answer in each section. Scoring range from 0 to 100. Higher score extremely satisfied and lower score equals extremely dissatisfied. |
| Surgical Interventions | Post-op Day 1 of surgery to 6 months | No secondary surgical interventions. |
Contacts
Primary ContactJames Kuras
Backup ContactKathleen Cascino, RN, BSHS
Outcome results
None listed