Retrospective Study With Patients Treated With STALIF® C or M and Ti or FLX Implants for 1 and 2 Levels

Degenerative Disc Disease Clinical Trial

— Stalif  

Official title:

Multicenter, Retrospective, Observational Clinical Study to Evaluate Clinical Outcome Measures and Safety Profiles for Patients With SDDD Treated With STALIF® C, or M, Ti or FLX Implants for 1 and 2 Levels.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05610397
• Other study ID #: VAL-P-0109
• Status: Not yet recruiting
• Start date: April 24, 2023
• Est. completion date: September 2024

Study information

• Verified date: November 2022
• Source: Centinel Spine
• Contact: James Kuras
• Phone: (484) 887-8829
• Email: j.kuras[@]centinelspine.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Grade 1 Spondylolisthesis
• Intervertebral Disc Degeneration
• Retrolisthesis
• Spinal Diseases
• Spondylolisthesis
• Symptomatic Cervical Disc Disease

Intervention

Device:
• STALIF®
STALIF® C, or M, Ti or FLX

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centinel Spine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI) Questionnaire	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.	Change from baseline at 24 months
Primary	Neck Disability Index (NDI)	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.	Change from baseline at 24 months
Secondary	Patient Self Satisfaction Survey	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.	Post-op at 24 months
Secondary	Surgical Interventions	No secondary surgical interventions.	Post-op Day 1 of surgery to 6 months
Secondary	Adverse Events	Adverse events	Day of surgery to 12 months
Secondary	Surgeon Self Satisfaction Survey	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.	Post-op at 24 months
Secondary	Quality of Lift Questionnaire (SF-12) Prospective Arm of Study	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.	Post-op at 24 months.