Post-traumatic Arthritis Associated With Joint Injury



Status:Active, not recruiting
Conditions:Arthritis, Hospital
Therapuetic Areas:Rheumatology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2012
End Date:December 2016

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Assessment of Biomarkers Associated With Joint Injury and Subsequent Post-Traumatic Arthritis

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.

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)
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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