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Post-traumatic Arthritis Associated With Joint Injury

NCT01792791 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2016-12-19

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

Tissue sample collection at the time of surgery

Spanning surgery * A blood sample (32.5 ml) * joint aspirate (removal of synovial fluid) from both knees * urine sample ORIF surgery * Joint aspirate (removal of synovial fluid) from both knees * A blood sample (32.5 ml) * Urine Sample If patients only require one surgery, sample will be collected only once.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Duke University

    lead OTHER

Principal Investigators

  • Steven Olson, MD · Duke University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01792791 on ClinicalTrials.gov