Degenerative Disc DiseaseCOMPASSNCT06226272
Clinical Outcome Measure at Stryker Spine
An observational study of Degenerative Disc Disease and Degenerative Scoliosis, run by VB Spine, LLC at 7 sites in United States.
Trial summary
This is a multicenter, prospective, retrospective, Post Market Clinical Follow-up (PMCF) study in subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared Instructions for Use (IFU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Degenerative Scoliosis
- What is being tested?
- Spinal Fusion and Spinal Deformities Correction
- Type of treatment
- Medical device
- How many people
- 5,222 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Jan 2025to 29 Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared IFUs and Surgical Technique Guides (STGs) by a participating investigator and are willing to complete the following patient-reported outcome measures (PROMs) at the study-specific time points.
Who may be able to join
- To be eligible to participate in the study, the potential subject must meet all inclusion criteria specific to the Stryker system being evaluated, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.
Who cannot join
- The exclusion criteria are based on the contraindications as presented in the Stryker device cleared IFUs, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Texas Spine & Scoliosis
Austin, Texas, 78705
Devender Singh, PhD, dpsingh@ascension.org
Eeric Truumees, MD
- Recruiting
Cleveland Clinc
Cleveland, Ohio, 44195
Research Coordinator, 216-445-1741, robinsn8@ccf.org
Ghaith Habboub, MD
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Keyla Guevara, Keyla.D.Guevara@uth.tmc.edu
Minal Bhadane, PhD, (419) 377-4566, minal.bhadane.1@uth.tmc.edu
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Megan Gauthier, gauthier.megan2@mayo.edu
Stephen Pirris, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Richard Call, richard.call@vumc.org
Amir M Abtahi, MD
- Recruiting
MaineHealth Neurosurgery and Spine
Scarborough, Maine, 04074
Chelsea Ruel, chelsea.ruel@mainehealth.org
Robert D. Ecker, MD
- Recruiting
Michigan Orthopaedic Surgeons
Southfield, Michigan, 48033
Reily Nesson, reily@researchtex.com
Jad Khalil, MD
About this study
Official title: Clinical Outcome Measure at Stryker Spine: COMPASS
This is a multicenter, prospective, retrospective, Post Market Clinical Follow-up (PMCF) study in subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared Instructions for Use (IFU).
Read the detailed description
Stryker Spine has a broad portfolio of spinal devices used to stabilize the spine. This PMCF study is designed to collect data on the performance and safety of the devices over their lifetime of 24 months post-implantation. Four protocols have been designed to aid in this process, a master and three sub-protocols. The sub-protocols are based on body region and indication:
- S-S-102-A Cervical: Interbody Devices (IBDs), Vertebral Body Replacement Devices (VBRs), Internal Fixation Devices, and Vitoss
- S-S-102-B Thoracolumbar: IBDs, VBRs, Internal Fixation Devices, and Vitoss
- S-S-102-C Adult Spinal Deformities: IBDs, Internal Fixation Devices, and Vitoss Each of the sub-protocols has its own specific performance endpoint and hypothesis, radiographical data assessments, and SAPs. Safety data will be collected throughout the study.
- Conditions
- Degenerative Disc Disease, Degenerative Scoliosis
- Being tested
- Spinal Fusion, Spinal Deformities Correction
- Keywords
- Device: Cervical or Thoracolumbar Spinal fusion, Device: Adult Spinal Deformities
- 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.
Spinal FusionDevice
Cervical Spinal Fusion
Spinal FusionDevice
Thoracic / Lumbar Spinal Fusion
Spinal Deformities CorrectionDevice
Spinal Deformities Correction
| Study group | Role | What they receive |
|---|---|---|
| S-S-102-A: Cervical Sub-Protocol | The study population includes subjects who are surgically treated with a Stryker device for a cervical condition per the specific device cleared IFUs and Surgical Technique Guides (STGs), by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points. Receives: Device: Spinal Fusion | |
| S-S-102-B: Thoracolumbar Sub-Protocol | The study population includes subjects who are surgically treated with a Stryker device for a thoracic/lumbar condition per the specific device cleared IFUs and STGs, by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points. Receives: Device: Spinal Fusion | |
| S-S-102-C: Adult Spinal Deformities | The study population includes subjects who are surgically treated with a Stryker device for a spinal deformity condition per the specific device cleared IFUs and STGs, by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points. Receives: Device: Spinal Deformities Correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
S-S-102-A
Mean change in the subject's Neck Disability Index (NDI) score.
Measured: Baseline through 24-months post-op.
S-S-102-B
Mean change in the subject's Oswestry Disability Index (ODI) score.
Measured: Baseline through 24-months post-op.
S-S-102-C
Mean change in the subject's Scoliosis Research Society-22 revised (SRS-22r).
Measured: Baseline through 24-months post-op.
Secondary outcomes (3)
S-S-102-A
The incidence of the following safety events:
- Serious Adverse Events (AEs)
- Device-related AEs
- Procedure-related AEs
- Operative AEs
- Secondary spine surgeries
Measured: Surgery through 24-months post-op.
S-S-102-B
The incidence of the following safety events:
- Serious Adverse Events (AEs)
- Device-related AEs
- Procedure-related AEs
- Operative AEs
- Secondary spine surgeries
Measured: Surgery through 24-months post-op.
S-S-102-C
The incidence of the following safety events:
- Serious Adverse Events (AEs)
- Device-related AEs
- Procedure-related AEs
- Operative AEs
- Secondary spine surgeries
Measured: Surgery through 24-months post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start28 Jan 2025
- Primary completion29 Jan 2029 (estimated)
- Study completion29 Jan 2032 (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
- Cohort
- Time perspective
- Other
- Enrolment
- 5,222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VB Spine, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jad G. Khalil, MD, Principal investigator, Michigan Orthopaedic Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226272
- Sponsor's protocol ID
- S-S-102
- Acronym
- COMPASS
- Status last verified
- Jun 2026
- First submitted
- 4 Jan 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome Measure at Stryker Spine: COMPASS
- ClinicalTrials.gov ID
- NCT06226272
- Acronym / sponsor ID
- COMPASS / S-S-102
- Conditions
- Degenerative Disc Disease, Degenerative Scoliosis
- Keywords
- Device: Cervical or Thoracolumbar Spinal fusion, Device: Adult Spinal Deformities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,222 participants (estimated)
- Lead sponsor
- VB Spine, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 29 Jan 2029 (estimated)
- Study completion
- 29 Jan 2032 (estimated)
- First posted
- 26 Jan 2024 (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 multicenter, prospective, retrospective, Post Market Clinical Follow-up (PMCF) study in subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared Instructions for Use (IFU).
Detailed description
Stryker Spine has a broad portfolio of spinal devices used to stabilize the spine. This PMCF study is designed to collect data on the performance and safety of the devices over their lifetime of 24 months post-implantation. Four protocols have been designed to aid in this process, a master and three sub-protocols. The sub-protocols are based on body region and indication:
- S-S-102-A Cervical: Interbody Devices (IBDs), Vertebral Body Replacement Devices (VBRs), Internal Fixation Devices, and Vitoss
- S-S-102-B Thoracolumbar: IBDs, VBRs, Internal Fixation Devices, and Vitoss
- S-S-102-C Adult Spinal Deformities: IBDs, Internal Fixation Devices, and Vitoss Each of the sub-protocols has its own specific performance endpoint and hypothesis, radiographical data assessments, and SAPs. Safety data will be collected throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| S-S-102-A: Cervical Sub-Protocol | – | Device: Spinal FusionThe study population includes subjects who are surgically treated with a Stryker device for a cervical condition per the specific device cleared IFUs and Surgical Technique Guides (STGs), by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points. |
| S-S-102-B: Thoracolumbar Sub-Protocol | – | Device: Spinal FusionThe study population includes subjects who are surgically treated with a Stryker device for a thoracic/lumbar condition per the specific device cleared IFUs and STGs, by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points. |
| S-S-102-C: Adult Spinal Deformities | – | Device: Spinal Deformities CorrectionThe study population includes subjects who are surgically treated with a Stryker device for a spinal deformity condition per the specific device cleared IFUs and STGs, by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared IFUs and Surgical Technique Guides (STGs) by a participating investigator and are willing to complete the following patient-reported outcome measures (PROMs) at the study-specific time points.
Key inclusion criteria (1 listed)
- To be eligible to participate in the study, the potential subject must meet all inclusion criteria specific to the Stryker system being evaluated, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.
Key exclusion criteria (1 listed)
- The exclusion criteria are based on the contraindications as presented in the Stryker device cleared IFUs, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.
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 |
|---|---|---|
| Spinal FusionCervical Spinal Fusion | Device | S-S-102-A: Cervical Sub-Protocol |
| Spinal FusionThoracic / Lumbar Spinal Fusion | Device | S-S-102-B: Thoracolumbar Sub-Protocol |
| Spinal Deformities CorrectionSpinal Deformities Correction | Device | S-S-102-C: Adult Spinal Deformities |
Primary outcome
S-S-102-A
Time frame: Baseline through 24-months post-op.
Mean change in the subject's Neck Disability Index (NDI) score.
S-S-102-B
Time frame: Baseline through 24-months post-op.
Mean change in the subject's Oswestry Disability Index (ODI) score.
S-S-102-C
Time frame: Baseline through 24-months post-op.
Mean change in the subject's Scoliosis Research Society-22 revised (SRS-22r).
3 secondary outcomes
S-S-102-A
Time frame: Surgery through 24-months post-op.
S-S-102-B
Time frame: Surgery through 24-months post-op.
S-S-102-C
Time frame: Surgery through 24-months post-op.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Jad G. Khalil, MD principal investigator
Michigan Orthopaedic Surgeons
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Degenerative Scoliosis, run by VB Spine, LLC at 7 sites in United States.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Majer (866-526-4171, mary.majer@vbspineco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S-S-102-A (time frame: Baseline through 24-months post-op.). The study lists 3 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 26 Jun 2026.