NCT03147118

Brief Summary

The objective of this study is to evaluate the accuracy of trapeziometacarpal injections using palpation alone. The importance of this study is one of education, cost containment, and decreased risk to the patient. If it can be shown that the accuracy of trapeziometacarpal injections using palpation alone is similar to the reported accuracy of ultrasound and fluoroscopy, then these guided techniques may not be needed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

May 8, 2017

Last Update Submit

September 20, 2024

Conditions

Keywords

trapeziometacarpal arthritis

Outcome Measures

Primary Outcomes (1)

  • Accuracy of injection

    Accuracy judged in a blinded fashion, rated injection in joint or out of joint

    radiograph immediately after injection (<5 mins)

Interventions

ArthrogramDIAGNOSTIC_TEST

Contrast dye will be included in the standard injection of lidocaine and corticosteroid. After injection, the participant will have 2 radiograph views of the thumb.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients diagnosed with trapeziometacarpal arthritis and a treatment plan including intra-articular steroid injections

You may qualify if:

  • The patient has clinical signs of trapeziometacarpal arthritis and are willing to obtain a post injection x-ray
  • The patient is over the age of 18 years of age.

You may not qualify if:

  • The patient has a known allergy to contrast dye
  • The patient has a planned surgery on the trapeziometacarpal joint within 6 weeks following injection
  • Patients who are pregnant or believe they may be pregnant
  • Prisoners
  • Patients who are unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hand Center

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Interventions

Arthrography

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • John Sanders, MD

    Prisma Health-Upstate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 10, 2017

Study Start

May 1, 2017

Primary Completion

September 15, 2017

Study Completion

September 15, 2017

Last Updated

September 24, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations