An observational study in Arthritis, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-19.
Sponsored by Duke University · 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.
40 patients with a closed unilateral articular fracture of the knee requiring operative treatment will be enrolled over an 18 month period. Tissue samples including synovial fluid from the injured and contralateral knee, serum and urine will be collected pre-operatively at the time of framing and ORIF. If patients only need to have one surgery (ORIF) sample will be collected only once. MRI imaging of the injured knee will be obtained after fixation at between week 6 and 8 and at 18 months. Tissue samples will be analyzed for established biomarkers of joint inflammation and degradation. Patients will be followed for 18 months to assess for signs of post-traumatic arthritis. Imaging with plain film and MRI will occur at 18 months. MRI imaging analysis of cartilage thickness and composition changes will be assessed in the injured knees. Assessment of articular cartilage and joint space narrowing and KOOS will be correlated to biomarkers that may be indicative and predictive of joint degeneration and the development of PTA.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 20 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Adults that are at least 18 years old and had a unilateral closed intra articular fracture of the knee that requires surgery.
Exclusion Criteria:
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.
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.
Time frame: 18 months after Injury
KOOS questionnaire
Participants will be scheduled for an MRI 18 months after surgery and a questionnaire will be completed at that time.
Time frame: Participants will complete this questionnaire at the 18 month follow up
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.
Time frame: Between week 2 and 6 and at 18 months after definitive fixation
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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