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

Not yet recruiting

• Conditions: Degenerative Disc Disease; Symptomatic Cervical Disc Disease; Grade 1 Spondylolisthesis; Retrolisthesis
• Interventions: Device: STALIF®

• Registration Number: NCT05610397
• Lead Sponsor: Centinel Spine

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.

Study Timeline

• Study First Submitted: 2022-10-28
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-09
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12
• Study Start: 2023-04-24
• Primary Completion: 2024-04-30
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2 level STALIF® M FLX	STALIF®	25 patients who have a 2 level implant with STALIF® M FLX
1 level STALIF® C FLX	STALIF®	25 patients who have a 1 level implant with STALIF® C FLX
1 level STALIF® M Ti	STALIF®	25 patients who have a 1 level implant with STALIF® M Ti
2 level STALIF® M Ti	STALIF®	25 patients who have a 2 level implant with STALIF® M Ti
1 level STALIF® C Ti	STALIF®	25 patients who have a 1 level implant with STALIF® C Ti
1 level STALIF® M FLX	STALIF®	25 patients who have a 1 level implant with STALIF® M FLX
2 level STALIF® C Ti	STALIF®	25 patients who have a 2 level implant with STALIF® C Ti
2 level STALIF® C FLX	STALIF®	25 patients who have a 2 level implant with STALIF® C FLX

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Surgical Interventions	Post-op Day 1 of surgery to 6 months	No secondary surgical interventions.
Adverse Events	Day of surgery to 12 months	Adverse events
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.
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.