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

Centinel Spine

Status: Not yet enrolling

Conditions: Symptomatic Cervical Disc Disease; Degenerative Disc Disease; Retrolisthesis; Grade 1 Spondylolisthesis

Treatments: Device: STALIF®

Study type: Observational

Funder types: Industry

Identifiers

NCT05610397

VAL-P-0109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 8 patient groups

1 level STALIF® C Ti

Description:

25 patients who have a 1 level implant with STALIF® C Ti

Treatment:

Device: STALIF®

1 level STALIF® C FLX

Description:

25 patients who have a 1 level implant with STALIF® C FLX

Treatment:

Device: STALIF®

1 level STALIF® M Ti

Description:

25 patients who have a 1 level implant with STALIF® M Ti

Treatment:

Device: STALIF®

1 level STALIF® M FLX

Description:

25 patients who have a 1 level implant with STALIF® M FLX

Treatment:

Device: STALIF®

2 level STALIF® C Ti

Description:

25 patients who have a 2 level implant with STALIF® C Ti

Treatment:

Device: STALIF®

2 level STALIF® C FLX

Description:

25 patients who have a 2 level implant with STALIF® C FLX

Treatment:

Device: STALIF®

2 level STALIF® M Ti

Description:

25 patients who have a 2 level implant with STALIF® M Ti

Treatment:

Device: STALIF®

2 level STALIF® M FLX

Description:

25 patients who have a 2 level implant with STALIF® M FLX

Treatment:

Device: STALIF®