We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inflammatory Response Following Intraarticular Fracture (PTOA)

This study is currently recruiting participants.
Verified June 2017 by Justin Haller, University of Utah
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514643
First Posted: January 23, 2012
Last Update Posted: June 19, 2017
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.
Information provided by (Responsible Party):
Justin Haller, University of Utah
  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 Justin Haller, University of Utah:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
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
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 ClinicalTrials.gov identifier (NCT number): NCT01514643


Contacts
Contact: Michael Miller 801-587-2355 michael.miller@hsc.utah.edu

Locations
United States, Utah
University of Utah Orthopedics Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Michael Miller    801-587-2355    michael.miller@hsc.utah.edu   
Principal Investigator: Justin Haller, MD         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Justin Haller, MD University of Utah Orthopedics
  More Information

Responsible Party: Justin Haller, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01514643     History of Changes
Other Study ID Numbers: 51134
First Submitted: December 21, 2011
First Posted: January 23, 2012
Last Update Posted: June 19, 2017
Last Verified: June 2017

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:
Osteoarthritis
Fractures, Bone
Intra-Articular Fractures
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries