Trials Sponsors Conditions Drugs Pricing

Conditions

Lumbar Disease

Outcome Measures

Primary Outcomes (1)

Compare Bony Fusion Rates Radiographically Using CT Scans
Primary Outcome: To compare bony fusion rates at two years among the three study arms, using the Brantigan, Steffee and Fraser scale. Post-operative CT scans will be evaluated at 24 months for evidence of new solid osseous trabeculations bridging across the interspace.
24 months

Secondary Outcomes (3)

Bony Fusion Rates Compared Clinically Using the Visual Analog Scale (VAS) Survey
3 months, 6 months, 12 months, 24 months
Bony Fusion Rates Compared Clinically Using the Oswestry Disability Index v2 (ODI v2) Survey
3 months, 6 months, 12 months, 24 months
Bony Fusion Rates Compared Clinically Using the Short Form 36 Health Survey v2 (SF-36 v2)
3 months, 6 months, 12 months, 24 months

Other Outcomes (2)

Safety Outcome: Immediate and Delayed Medical and Surgical Complications Compared Among the Three Arms
post-surgery, 6 weeks, 3 months, 6 months, 12 months, 24 months
Exploratory Outcome: Compare Bony Fusion Rates Using X-ray Based Classification Scale
12 months and 24 months

Study Arms (3)

Group 1

OTHER

Unilateral pedicle screws

Device: Pedicle Screw

Group 2

OTHER

Ipsilateral pedicle screws, contralateral facet screw

Device: Pedicle Screw

Group 3

OTHER

Bilateral pedicle screws

Device: Pedicle Screw

Interventions

Pedicle ScrewDevice

Group 1Group 2Group 3

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18-80 years.
Symptomatic single-level lumbar disease including lumbosacral junction.

Sponsors & Collaborators

H Francis Farhadi, MD, PhD
Otherlead

Study Sites (1)

The Ohio State Unviersity

Columbus, Ohio, 43210, United States

MeSH Terms

Conditions

Disease

Interventions

Pedicle Screws

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bone ScrewsInternal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Limitations and Caveats

This study is being ended early due to low enrollment. No analysis is planned due to the small cohort.

Results Point of Contact

Title: Shelby Miracle
Organization: OhioU

Study Officials

H. Francis Farhadi, MD, PhD
Ohio State University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 27, 2013

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (2)

Study Arms (3)

Group 1

Group 2

Group 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations