Degenerative Disc DiseaseStalifNCT05610397
Retrospective Study With Patients Treated With STALIF® C or M and Ti or FLX Implants for 1 and 2 Levels
An observational study of Degenerative Disc Disease and Grade 1 Spondylolisthesis, run by Centinel Spine.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Degenerative Disc Disease, Grade 1 Spondylolisthesis, Retrolisthesis
- What is being tested?
- STALIF®
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 24 Apr 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgeon medical records. Hospital medical records.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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.
- Conditions
- Degenerative Disc Disease, Grade 1 Spondylolisthesis, Retrolisthesis, Symptomatic Cervical Disc Disease
- Being tested
- STALIF®
- Keywords
- Retrolisthesis, Grade 1 Spondyloisthesis, Degenerative Disc Disease, Symptomatic Cervical Disc Disease
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STALIF®Device
Also called STALIF® Cervical, Midline, Lumbar
STALIF® C, or M, Ti or FLX
| Study group | Role | What they receive |
|---|---|---|
| 1 level STALIF® C Ti | 25 patients who have a 1 level implant with STALIF® C Ti Receives: Device: STALIF® | |
| 1 level STALIF® C FLX | 25 patients who have a 1 level implant with STALIF® C FLX Receives: Device: STALIF® | |
| 1 level STALIF® M Ti | 25 patients who have a 1 level implant with STALIF® M Ti Receives: Device: STALIF® | |
| 1 level STALIF® M FLX | 25 patients who have a 1 level implant with STALIF® M FLX Receives: Device: STALIF® | |
| 2 level STALIF® C Ti | 25 patients who have a 2 level implant with STALIF® C Ti Receives: Device: STALIF® | |
| 2 level STALIF® C FLX | 25 patients who have a 2 level implant with STALIF® C FLX Receives: Device: STALIF® | |
| 2 level STALIF® M Ti | 25 patients who have a 2 level implant with STALIF® M Ti Receives: Device: STALIF® | |
| 2 level STALIF® M FLX | 25 patients who have a 2 level implant with STALIF® M FLX Receives: Device: STALIF® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline at 24 months
Secondary outcomes (5)
Patient Self Satisfaction Survey
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.
Measured: Post-op at 24 months
Surgical Interventions
No secondary surgical interventions.
Measured: Post-op Day 1 of surgery to 6 months
Adverse Events
Adverse events
Measured: Day of surgery to 12 months
Surgeon Self Satisfaction Survey
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.
Measured: Post-op at 24 months
Quality of Lift Questionnaire (SF-12) Prospective Arm of Study
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.
Measured: Post-op at 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start24 Apr 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centinel Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernd Illerhaus, MD, Principal investigator, Orthopädisch-Neurochirurgisches Zentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610397
- Sponsor's protocol ID
- VAL-P-0109
- Acronym
- Stalif
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Retrospective Chart Review Study with a Prospective Arm. Surgery occurred between 2014 - present.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05610397
- Acronym / sponsor ID
- Stalif / VAL-P-0109
- Conditions
- Degenerative Disc Disease, Grade 1 Spondylolisthesis, Retrolisthesis, Symptomatic Cervical Disc Disease
- Keywords
- Retrolisthesis, Grade 1 Spondyloisthesis, Degenerative Disc Disease, Symptomatic Cervical Disc Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centinel SpineIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 level STALIF® C Ti | – | Device: STALIF®25 patients who have a 1 level implant with STALIF® C Ti |
| 1 level STALIF® C FLX | – | Device: STALIF®25 patients who have a 1 level implant with STALIF® C FLX |
| 1 level STALIF® M Ti | – | Device: STALIF®25 patients who have a 1 level implant with STALIF® M Ti |
| 1 level STALIF® M FLX | – | Device: STALIF®25 patients who have a 1 level implant with STALIF® M FLX |
| 2 level STALIF® C Ti | – | Device: STALIF®25 patients who have a 2 level implant with STALIF® C Ti |
| 2 level STALIF® C FLX | – | Device: STALIF®25 patients who have a 2 level implant with STALIF® C FLX |
| 2 level STALIF® M Ti | – | Device: STALIF®25 patients who have a 2 level implant with STALIF® M Ti |
| 2 level STALIF® M FLX | – | Device: STALIF®25 patients who have a 2 level implant with STALIF® M FLX |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgeon medical records. Hospital medical records.
Key inclusion criteria (5 listed)
- 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:
- Skeletally mature at the time of surgery with clinical and radiological evidence of degenerative disc disease of the cervical or lumbar spine.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STALIF®Also: STALIF® Cervical, Midline, LumbarSTALIF® C, or M, Ti or FLX | Device | 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 |
Primary outcome
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.
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.
5 secondary outcomes
Patient Self Satisfaction Survey
Time frame: Post-op at 24 months
Surgical Interventions
Time frame: Post-op Day 1 of surgery to 6 months
Adverse Events
Time frame: Day of surgery to 12 months
Surgeon Self Satisfaction Survey
Time frame: Post-op at 24 months
Quality of Lift Questionnaire (SF-12) Prospective Arm of Study
Time frame: Post-op at 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No. Retrospective Chart Review Study with a Prospective Arm. Surgery occurred between 2014 - present.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Illerhaus, MD principal investigator
Orthopädisch-Neurochirurgisches Zentrum
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Grade 1 Spondylolisthesis, run by Centinel Spine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Kuras ((484) 887-8829, j.kuras@centinelspine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) Questionnaire (time frame: Change from baseline at 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.