NCT02510326

Brief Summary

The scaphotrapeziotrapezoid (STT) joint is a dome shaped joint in the radial wrist that is important in transfer of load from the thumb and radial hand to the scaphoid and the radioscaphoid and scaphocapitate joints. Arthritis in this joint is the second most common degenerative arthritis in the wrist, reported in 15% of wrist radiographs. The true incidence of arthritis in the STT joint however is unknown though we assume that most cases of arthritis are not clinically significant. Furthermore, the clinical and biomechanical significance of arthritis in this joint is unclear. The investigators' clinical impression is that the incidence of STT joint arthritis is inversely related to that of radiocarpal joint arthritis. In an ongoing study, we are examining the relationship between STT joint arthritis and radiocarpal joint arthritis on radiographs. We suggest that STT joint arthritis alters the biomechanics of the wrist by limiting movement of the scaphoid within the STT joint thereby protecting the wrist from radiocarpal arthritis by limiting instability of the scaphoid. The specific aims of this pilot study are to evaluate the movement of the arthritic scaphoid within the STT joint using a computer-generated model based on CT scan of the wrist and to compare this model with the already established model of the normal STT joint. The investigators' hypothesis is that there is significantly less motion in the arthritic STT joint.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2014

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

March 23, 2014

Last Update Submit

January 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • motion in the STT joint

    A kinematic model based on data from the wrist CT acquired in the different wrist positions.(kinematic data) will be compared to an existent "normal" model, based on 7 CT scans of normal STT joints.

    1 year

Eligibility Criteria

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

Five patients being treated by the PI that have a diagnosis or a finding of STT joint arthritis stage 3 on X-ray will be included in the study.

You may qualify if:

  • Patients with STT joint osteoarthritis(OA) - stage 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, Israel

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director hand and upper extremity service

Study Record Dates

First Submitted

March 23, 2014

First Posted

July 29, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations