Clinical Outcome Measure at Stryker Spine

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
VB Spine, LLC
Study ID
NCT06226272
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spinal Fusion — DEVICE
    Cervical Spinal Fusion
  • Spinal Fusion — DEVICE
    Thoracic / Lumbar Spinal Fusion
  • Spinal Deformities Correction — DEVICE
    Spinal Deformities Correction

Study Details

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).

Key Dates

Start date
Jan 28, 2025
Status verified
Jun 2026
Primary completion
Jan 29, 2029
Completion
Jan 29, 2032

Study Design

Enrollment
5,222 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

S-S-102-A [ Time Frame: Baseline through 24-months post-op. ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo Clinic FloridaJacksonvilleFlorida32224
Megan Gauthier
[email protected]
Stephen Pirris, MD (PRINCIPAL_INVESTIGATOR)
MaineHealth Neurosurgery and SpineScarboroughMaine04074
Chelsea Ruel
[email protected]
Robert D. Ecker, MD (PRINCIPAL_INVESTIGATOR)
Michigan Orthopaedic SurgeonsSouthfieldMichigan48033
Reily Nesson
[email protected]
Jad Khalil, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClincClevelandOhio44195
Research Coordinator
[email protected]
216-445-1741
Ghaith Habboub, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Richard Call
[email protected]
Amir M Abtahi, MD (PRINCIPAL_INVESTIGATOR)
Texas Spine & ScoliosisAustinTexas78705
Devender Singh, PhD
[email protected]
Eeric Truumees, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at HoustonHoustonTexas77030
Keyla Guevara
[email protected]
Minal Bhadane, PhD
[email protected]
(419) 377-4566
James E. Showery, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

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Mayo Clinic Florida· Jacksonville, FLMaineHealth Neurosurgery and Spine· Scarborough, MEMichigan Orthopaedic Surgeons· Southfield, MICleveland Clinc· Cleveland, OHVanderbilt University Medical Center· Nashville, TNTexas Spine & Scoliosis· Austin, TX

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