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NCT Number: NCT01792791

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 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.

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27707, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tissue sample collection at the time of surgery

Procedure

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.

Primary outcomes

  1. Markers of joint tissue degeneration following articular fracture

    Time frame: 18 months after Injury

    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.

Secondary outcomes

  1. KOOS questionnaire

    Time frame: Participants will complete this questionnaire at the 18 month follow up

    Participants will be scheduled for an MRI 18 months after surgery and a questionnaire will be completed at that time.

Other outcomes

  1. Change from baseline at 18 months of the extracellular matrix and morphology of knee cartilage using MRI

    Time frame: Between week 2 and 6 and at 18 months after definitive fixation

    Two MRIs will be scheduled for all the study participants at 4 weeks (with a 2-6 weeks window) and at 18 months.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2013
Registry last updated
Dec 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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