Inflammatory Response Following Intraarticular Fracture (PTOA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Thomas Higgins, University of Utah
ClinicalTrials.gov Identifier:
NCT01514643
First received: December 21, 2011
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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
Intraarticular Fracture and Post-traumatic Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Inflammatory Response Following Intraarticular Fracture

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Post-traumatic osteoarthritis (PTOA) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Compare mean concentrations of inflammatory cytokines profiles between each patients' injured and uninjured joints.


Biospecimen Retention:   Samples Without DNA

Synovial fluid and blood serum


Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting with tibial plateau or plafond fracture.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514643

Contacts
Contact: Nousheen Alasti 801-587-5488 nousheen.alasti@hsc.utah.edu

Locations
United States, Utah
University of Utah Orthopedics Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Nousheen Alasti    801-587-5488    nousheen.alasti@hsc.utah.edu   
Principal Investigator: Thomas Higgins, MD         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Thomas Higgins, MD University of Utah Orthopedics
  More Information

No publications provided

Responsible Party: Thomas Higgins, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01514643     History of Changes
Other Study ID Numbers: 51134
Study First Received: December 21, 2011
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Osteoarthritis
Intra-Articular Fractures
Wounds and Injuries
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 25, 2014