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

January 11, 2023 updated by: Centinel Spine

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surgeon medical records. Hospital medical records.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 level STALIF® C Ti
25 patients who have a 1 level implant with STALIF® C Ti
Device: STALIF®
STALIF® C, or M, Ti or FLX
Other Names:
  • STALIF® Cervical, Midline, Lumbar
1 level STALIF® C FLX
25 patients who have a 1 level implant with STALIF® C FLX
Device: STALIF®
STALIF® C, or M, Ti or FLX
Other Names:
  • STALIF® Cervical, Midline, Lumbar
1 level STALIF® M Ti
25 patients who have a 1 level implant with STALIF® M Ti
Device: STALIF®
STALIF® C, or M, Ti or FLX
Other Names:
  • STALIF® Cervical, Midline, Lumbar
1 level STALIF® M FLX
25 patients who have a 1 level implant with STALIF® M FLX
Device: STALIF®
STALIF® C, or M, Ti or FLX
Other Names:
  • STALIF® Cervical, Midline, Lumbar
2 level STALIF® C Ti
25 patients who have a 2 level implant with STALIF® C Ti
Device: STALIF®
STALIF® C, or M, Ti or FLX
Other Names:
  • STALIF® Cervical, Midline, Lumbar
2 level STALIF® C FLX
25 patients who have a 2 level implant with STALIF® C FLX
Device: STALIF®
STALIF® C, or M, Ti or FLX
Other Names:
  • STALIF® Cervical, Midline, Lumbar
2 level STALIF® M Ti
25 patients who have a 2 level implant with STALIF® M Ti
Device: STALIF®
STALIF® C, or M, Ti or FLX
Other Names:
  • STALIF® Cervical, Midline, Lumbar
2 level STALIF® M FLX
25 patients who have a 2 level implant with STALIF® M FLX
Device: STALIF®
STALIF® C, or M, Ti or FLX
Other Names:
  • STALIF® Cervical, Midline, Lumbar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI) Questionnaire
Time Frame: 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.
Change from baseline at 24 months
Neck Disability Index (NDI)
Time Frame: 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.
Change from baseline at 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Day of surgery to 12 months
Adverse events
Day of surgery to 12 months
Patient Self Satisfaction Survey
Time Frame: 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.
Post-op at 24 months
Surgical Interventions
Time Frame: Post-op Day 1 of surgery to 6 months
No secondary surgical interventions.
Post-op Day 1 of surgery to 6 months
Surgeon Self Satisfaction Survey
Time Frame: 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.
Post-op at 24 months
Quality of Lift Questionnaire (SF-12) Prospective Arm of Study
Time Frame: 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.
Post-op at 24 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prospective Survey
Time Frame: Post 24 months
Oswestry Disability Index
Post 24 months
Prospective Survey
Time Frame: Post 24 months
Neck Disability Index
Post 24 months
Prospective Survey
Time Frame: Post 24 Months
SF-12
Post 24 Months
Prospective Survey
Time Frame: Post 24 months
Patient Self Satisfaction
Post 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centinel Spine

Investigators

  • Principal Investigator: Bernd Illerhaus, MD, Orthopädisch-Neurochirurgisches Zentrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 24, 2023

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

October 28, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 9, 2022

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAL-P-0109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Retrospective Chart Review Study with a Prospective Arm. Surgery occurred between 2014 - present.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Degenerative Disc Disease

Clinical Trials on STALIF®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe