NCT06226272

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,222

participants targeted

Target at P75+ for all trials

Timeline
67mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jan 2025Jan 2032

First Submitted

Initial submission to the registry

January 4, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

January 28, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2029

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2032

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

January 4, 2024

Last Update Submit

June 23, 2026

Conditions

Degenerative Disc DiseaseDegenerative Scoliosis

Keywords

Device: Cervical or Thoracolumbar Spinal fusionDevice: Adult Spinal Deformities

Outcome Measures

Primary Outcomes (3)

  • S-S-102-A

    Mean change in the subject's Neck Disability Index (NDI) score.

    Baseline through 24-months post-op.

  • S-S-102-B

    Mean change in the subject's Oswestry Disability Index (ODI) score.

    Baseline through 24-months post-op.

  • S-S-102-C

    Mean change in the subject's Scoliosis Research Society-22 revised (SRS-22r).

    Baseline through 24-months post-op.

Secondary Outcomes (3)

  • S-S-102-A

    Surgery through 24-months post-op.

  • S-S-102-B

    Surgery through 24-months post-op.

  • S-S-102-C

    Surgery through 24-months post-op.

Study Arms (3)

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.

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.

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.

Device: Spinal Deformities Correction

Interventions

Spinal FusionDEVICE

Cervical Spinal Fusion

S-S-102-A: Cervical Sub-Protocol
Spinal Deformities CorrectionDEVICE

Spinal Deformities Correction

S-S-102-C: Adult Spinal Deformities

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

MaineHealth Neurosurgery and Spine

Scarborough, Maine, 04074, United States

RECRUITING

Michigan Orthopaedic Surgeons

Southfield, Michigan, 48033, United States

RECRUITING

Cleveland Clinc

Cleveland, Ohio, 44195, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Texas Spine & Scoliosis

Austin, Texas, 78705, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Spinal Fusion

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

ArthrodesisOrthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Jad G. Khalil, MD

    Michigan Orthopaedic Surgeons

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Majer

CONTACT

866-526-4171mary.majer@vbspineco.com

Effa Gyamfi

CONTACT

866-526-4171effa.gyamfi@vbspineco.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 26, 2024

Study Start

January 28, 2025

Primary Completion (Estimated)

January 29, 2029

Study Completion (Estimated)

January 29, 2032

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(7)