NCT03616340

Brief Summary

The proposed study will compare the efficacy of Triamcinolone versus Ketorolac for intra-articular injection of the knee and shoulder

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2018

Status
unknown

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

First Submitted

Initial submission to the registry

July 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 6, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

July 31, 2018

Last Update Submit

August 3, 2018

Conditions

Knee ArthritisShoulder ArthritisShoulder ImpingementMeniscus LesionRotator Cuff TearRotator Cuff Tear Arthropathy

Outcome Measures

Primary Outcomes (2)

  • Pain level: VAS score

    VAS score

    0-6 months

  • length pain relief

    length of time patient reports pain relief

    0-6 months

Study Arms (2)

Ketorolac

EXPERIMENTAL
Drug: Shoulder injectionDrug: knee injection

Kenalog

EXPERIMENTAL
Drug: Shoulder injectionDrug: knee injection

Interventions

Shoulder injectionDRUG

intra articular or subacromial shoulder injection

KenalogKetorolac
knee injectionDRUG

intra-articular knee injection

KenalogKetorolac

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee and shoulder arthritis
  • shoulder impingement
  • rotator cuff tear

You may not qualify if:

  • chronic pain management
  • allergy to NSAIDs or steroids
  • prior surgery
  • kidney disease that would preclude NSAID administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Impingement SyndromeRotator Cuff InjuriesRotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesRuptureTendon InjuriesChondrocalcinosisArthritisCrystal Arthropathies

Central Study Contacts

Miguel ramirez, MD

CONTACT

17857661273maramirez09@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 6, 2018

Study Start

August 1, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2020

Last Updated

August 6, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share