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

NCT05610397 | Unknown FDA Device

• 1 other identifier: VAL-P-0109
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Retrolisthesis; Grade 1 Spondyloisthesis; Degenerative Disc Disease; Symptomatic Cervical Disc Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Patient Self Satisfaction Survey

  Post-op at 24 months

• Surgical Interventions

  Post-op Day 1 of surgery to 6 months

• Adverse Events

  Day of surgery to 12 months

• Surgeon Self Satisfaction Survey

  Post-op at 24 months

• Quality of Lift Questionnaire (SF-12) Prospective Arm of Study

  Post-op at 24 months.

Study Arms (8)

1 level STALIF® C Ti

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

Device: STALIF®

1 level STALIF® C FLX

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

Device: STALIF®

1 level STALIF® M Ti

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

Device: STALIF®

1 level STALIF® M FLX

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

Device: STALIF®

2 level STALIF® C Ti

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

Device: STALIF®

2 level STALIF® C FLX

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

Device: STALIF®

2 level STALIF® M Ti

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

Device: STALIF®

2 level STALIF® M FLX

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

Device: STALIF®

Interventions

STALIF® DEVICE

STALIF® C, or M, Ti or FLX

Also known as: STALIF® Cervical, Midline, Lumbar

1 level STALIF® C FLX; 1 level STALIF® C Ti; 1 level STALIF® M FLX; 1 level STALIF® M Ti; 2 level STALIF® C FLX; 2 level STALIF® C Ti; 2 level STALIF® M FLX; 2 level STALIF® M Ti

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgeon medical records. Hospital medical records.

You may qualify if:

• Diagnosed with up to a Grade1 spondylolisthesis or retrolisthesis or degenerative disc disease of the cervical or lumbar spine at time of surgery.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centinel Spine: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Bernd Illerhaus, MD

  Orthopädisch-Neurochirurgisches Zentrum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Kuras

CONTACT

(484) 887-8829; j.kuras@centinelspine.com

Kathleen Cascino, RN, BSHS

CONTACT

(908) 967-7299; k.cascino@centinelspine.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 9, 2022
• Study Start: April 24, 2023
• Primary Completion: April 30, 2024
• Study Completion: September 1, 2024
• Last Updated: January 12, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share