Clinical trial NCT05610397: Retrospective Study With Patients Treated With STALIF® C or M and Ti or FLX Implants for 1 and 2 Levels
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Disc Disease
Grade 1 Spondylolisthesis
Retrolisthesis
Symptomatic Cervical Disc Disease
Keywords: Retrolisthesis
Grade 1 Spondyloisthesis
Degenerative Disc Disease
Symptomatic Cervical Disc Disease
Lead sponsor: Centinel Spine
Sponsor class: INDUSTRY
First posted: 2022-11-09
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgeon medical records. Hospital medical records.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oswestry Disability Index (ODI) Questionnaire
timeFrame: Change from baseline at 24 months
measure: Neck Disability Index (NDI)
timeFrame: Change from baseline at 24 months
Secondary outcomes:
measure: Patient Self Satisfaction Survey
timeFrame: Post-op at 24 months
measure: Surgical Interventions
timeFrame: Post-op Day 1 of surgery to 6 months
measure: Adverse Events
timeFrame: Day of surgery to 12 months
measure: Surgeon Self Satisfaction Survey
timeFrame: Post-op at 24 months
measure: Quality of Lift Questionnaire (SF-12) Prospective Arm of Study
timeFrame: Post-op at 24 months.
Other outcomes:
Locations:
Study officials:
affiliation: Orthopädisch-Neurochirurgisches Zentrum
name: Bernd Illerhaus, MD
role: PRINCIPAL_INVESTIGATOR
References: