NCT02104726

Brief Summary

To compare relative efficacy of intraarticular steroid injection using anatomic landmarks vs. fluoroscopy guided technique in decreasing knee osteoarthritis pain 1 month after the procedure.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

April 2, 2014

Last Update Submit

December 11, 2017

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale (pain)

    Decrease in pain from baseline at one month

    1 month

Study Arms (2)

Blind Steroid Injection

ACTIVE COMPARATOR

Blind Steroid Injection for patients with OA deemed qualified for it clinically

Other: Blind Steroid Injection

Fluoroscopy guided steroid injection

ACTIVE COMPARATOR

Fluoroscopy guided Steroid Injection for patients with OA deemed qualified for it clinically. We want to see which one is better.

Other: Fluoroscopy guided steroid injection

Interventions

Fluoroscopy guided steroid injectionOTHER

We want to compare if there is a difference between the two arms, with the assumption that with fluoroscopy will deliver the steroid more accurately and see better outcomes.

Fluoroscopy guided steroid injection
Blind Steroid InjectionOTHER

Want to compare it to fluoroscopy guided, with assumption that it will be less effective in reducing pain

Blind Steroid Injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adults with knee OA clinically deemed to qualify for steroid injection

You may not qualify if:

  • \- Children Non-English Speakers Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 4, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 12, 2017

Record last verified: 2017-12