Health TrialsbyHealthPanel

Clinical Outcome Measure at Stryker Spine

ConditionsDegenerative Disc DiseaseDegenerative Scoliosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVB Spine, LLC

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Spinal Fusion

    Device

    Cervical Spinal Fusion

  • Spinal Fusion

    Device

    Thoracic / Lumbar Spinal Fusion

  • Spinal Deformities Correction

    Device

    Spinal Deformities Correction

Treatment groups

5,222 Participants
are divided into 3 treatment groups
Group A: S-S-102-A: Cervical Sub-Protocol1 intervention
Group B: S-S-102-B: Thoracolumbar Sub-Protocol1 intervention
Group C: S-S-102-C: Adult Spinal Deformities1 intervention

Trial outcomes

Primary outcomes

1

S-S-102-A

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

Time frame
Baseline through 24-months post-op.
2

S-S-102-B

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

Time frame
Baseline through 24-months post-op.
3

S-S-102-C

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

Time frame
Baseline through 24-months post-op.

Secondary outcomes

1

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

Time frame
Surgery through 24-months post-op.
2

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

Time frame
Surgery through 24-months post-op.
3

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

Time frame
Surgery through 24-months post-op.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VB Spine, LLC

Lead sponsor

Source ClinicalTrials.gov
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