Arthritis Clinical Trial
Official title:
Assessment of Biomarkers Associated With Joint Injury and Subsequent Post-Traumatic Arthritis
Verified date | August 2015 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects will be adult patients (over 18 years old) - Patients must present with a unilateral closed intra-articular fracture of the knee. Exclusion Criteria: - Pre-existing arthritis in the injured or contra-lateral knee, - Previous total knee replacement - Active joint infection - Pathologic fracture - Active inflammatory arthritis - Open fracture of the involved knee - Contra-lateral knee injury - HIV infection (if previously known) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from baseline at 18 months of the extracellular matrix and morphology of knee cartilage using MRI | Two MRIs will be scheduled for all the study participants at 4 weeks (with a 2-6 weeks window) and at 18 months. | Between week 2 and 6 and at 18 months after definitive fixation | No |
Primary | Markers of joint tissue degeneration following articular fracture | 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. | 18 months after Injury | No |
Secondary | KOOS questionnaire | Participants will be scheduled for an MRI 18 months after surgery and a questionnaire will be completed at that time. | Participants will complete this questionnaire at the 18 month follow up | No |
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