Inflammatory Response Following Intraarticular Fracture (PTOA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01514643
Recruitment Status : Recruiting
First Posted : January 23, 2012
Last Update Posted : May 30, 2018
Information provided by (Responsible Party):
Justin Haller, University of Utah

Brief Summary:
The purpose of the study is to investigate a relationship between the inflammatory response following intraarticular fracture and post-traumatic osteoarthritis. The investigators plan to evaluate the inflammatory cytokine profile in knee joint synovial fluid and blood serum in patients who sustain an intraarticular tibial plateau fracture and ankle joint synovial fluid and blood serum in patients who sustain an intraarticular tibial plafond fracture. This information will be combined with radiographs and patient outcome measures to determine a correlation between intraarticular inflammatory response and post-traumatic osteoarthritis.

Condition or disease
Intraarticular Fracture and Post-traumatic Osteoarthritis

Detailed Description:

Post-traumatic osteoarthritis (PTOA) is a common cause of disability following a traumatic event involving a joint. It is estimated that PTOA may affect up to 12% of the population with symptomatic osteoarthritis, and it is associated with significant cost to the healthcare system. Given that the majority of trauma patients are younger, the impact of the condition can be particularly devastating for those in the prime of their working careers.

PTOA can develop following a variety of joint injuries, but it most predictably occurs with articular fracture. The initial traumatic injury involves a complex process of articular impaction or displacement and soft tissue disruption that leads to articular exposure to blood and marrow, a local inflammatory response, abnormal joint loading, and subsequent chondrocyte necrosis and apoptosis. However, the mechanism(s) that lead to progression from the initial injury to end-stage PTOA are largely unknown.

Inflammation can have deleterious effects on a joint. Though inflammatory cytokines have been shown to stimulate bone repair through osteoclastogenesis and recruitment of osteoblastic cells, multiple studies have demonstrated that these cytokines play a role in cartilage degradation. Increased IL-1 and TNF-a expression has been found in the cartilage of patients with osteoarthritis, and these cytokines are transiently increased after traumatic injury. Other matrix molecules including matrix metalloproteinase (MMP)-3 and cartilage oligomeric matrix protein (COMP) can be persistently elevated in synovial fluid after ACL injury.

The effect of the initial inflammatory response after intraarticular fracture on the development of PTOA remains unknown. Several authors have found elevated levels of cytokines in joints affected by trauma. However, these studies evaluated patients following an anterior cruciate ligament (ACL) injury. An intraarticular fracture likely subjects the joint to more of an inflammatory response and may place the joint at greater risk for developing osteoarthritis. There are currently no studies that link elevated levels of the inflammatory cytokines and chemokines in the setting of intraarticular trauma with PTOA. Investigating the cytokine profile in a joint immediately following intraarticular injury could lead to early targeted drug therapy with cytokine inhibitors to modify the progression of PTOA.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Inflammatory Response Following Intraarticular Fracture
Study Start Date : October 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

tibial plateau or plafond fracture
Tibial plateau or plafond fracture based on radiographs and/or CT scan will have synovial fluid aspirated from both the injured and uninjured joints in either the operating room if a procedure is planned for within 24 hours or in the emergency department. While the patient is under anesthesia in the operating room, the investigators will obtain blood samples.

Primary Outcome Measures :
  1. Post-traumatic osteoarthritis (PTOA) [ Time Frame: 2 years ]
    Compare mean concentrations of inflammatory cytokines profiles between each patients' injured and uninjured joints.

Biospecimen Retention:   Samples Without DNA
Synovial fluid and blood serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting with tibial plateau or plafond fracture.

Inclusion Criteria:

  • 18 years of age or older
  • Radiographic evidence of tibial plateau fracture

Exclusion Criteria:

  • Less than 18 years of age
  • Greater than 60 years of age
  • Any history of pre-existing knee osteoarthritis based on previous diagnosis or suggestive history
  • Any history of autoimmune disease
  • Any history of contralateral intra-articular knee injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01514643

Contact: Michael Miller 801-587-2355

United States, Utah
University of Utah Orthopedics Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Michael Miller    801-587-2355   
Principal Investigator: Justin Haller, MD         
Sponsors and Collaborators
University of Utah
Principal Investigator: Justin Haller, MD University of Utah Orthopedics

Responsible Party: Justin Haller, M.D., University of Utah Identifier: NCT01514643     History of Changes
Other Study ID Numbers: 51134
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Keywords provided by Justin Haller, University of Utah:
tibial plateau fracture
tibial plafond fracture
inflammatory cytokine profile
synovial fluid
blood serum
Post-traumatic osteoarthritis (PTOA)

Additional relevant MeSH terms:
Fractures, Bone
Intra-Articular Fractures
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries