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NCT01792791 · ClinicalTrials.gov registry record

Post-traumatic Arthritis Associated With Joint Injury

A clinical trial, sponsored by Duke University.

Completed
Registry status
20
Enrollment target

NCT01792791: Completed study, sponsored by Duke University.

NCT01792791 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01792791 has completed, sponsored by Duke University.

COMPLETED
Registry status
20 participants
Enrollment target

Study Summary

Arthritis is the nation's most common cause of disability. An estimated 50 million U.S. adults (about 1 in 5) report doctor-diagnosed arthritis. Twenty three million U.S. adults of working age (18-64 years) have arthritis; and in this age group arthritis-attributable work limitations affect about 1 in 3 people. An estimated 12% of all patients seeking intervention for symptomatic arthritis have an etiology of previous trauma to the involved joint. The purpose of this study is to examine these inflammatory compounds in the joint fluid (synovial fluid), the joint lining (synovium), and in blood among subjects with isolated intra-articular fractures. The hypothesis is that early levels of intra-articular inflammation and markers of joint tissue degeneration following articular fracture in the human knee are predictive of the development of PTA (Post Traumatic Arthritis). Early levels of intra-articular inflammation and markers of joint tissue degeneration identified from human knee joints following articular injury are predictive of the development of PTA in the mouse knee. Samples of blood, urine and synovial fluid will be taken at the spanning frame surgery and only synovial fluid at the ORIF (Open Reduction Internal Fixation)surgery. Two MRIs (Magnetic Resonance Imaging) will be part of this study at 4 weeks and 18 months.Participants will complete a set of questionnaires(KOOS: Knee Injury and Osteoarthritis Outcome Score) at 4 weeks and 18 months.

Primary Outcome

Tissue samples will be collected at the time of surgery and they will be taken to Duke Basic Science lab where they will be analyzed.

Interventions

  • PROCEDURE Tissue sample collection at the time of surgery

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2012-10
Est. Completion 2016-12
Duke University

1,725 total trials

What the finished NCT01792791 record still lists

NCT01792791 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Tissue sample collection at the time of surgery is the first listed.

NCT01792791 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01792791 about?

NCT01792791 is a clinical study titled "Post-traumatic Arthritis Associated With Joint Injury". Arthritis is the nation's most common cause of disability. An estimated 50 million U.S. adults (about 1 in 5) report doctor-diagnosed arthritis. Twenty three million U.S. adults of working age (18-64 years) have arthritis; and in this age group arthritis-attributable work limitations affect about 1 ...

What is the current status of trial NCT01792791?

This trial is currently completed. The enrollment target is 20 participants. The study started on 2012-10. Estimated completion is 2016-12.

What interventions are being tested in trial NCT01792791?

The interventions under investigation include: Tissue sample collection at the time of surgery (PROCEDURE).

Who is sponsoring clinical trial NCT01792791?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01792791, the US trial registry maintained by the National Library of Medicine. NCT01792791 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.