Post-traumatic Arthritis Associated With Joint Injury

NCT01792791 | Completed

• 1 other identifier: Pro00038254
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• Markers of joint tissue degeneration following articular fracture

  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.

  18 months after Injury

Secondary Outcomes (1)

• KOOS questionnaire

  Participants will complete this questionnaire at the 18 month follow up

Other Outcomes (1)

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

  Between week 2 and 6 and at 18 months after definitive fixation

Study Arms (1)

Single Arm

Procedure: Tissue sample collection at the time of surgery

Interventions

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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults that are at least 18 years old and had a unilateral closed intra articular fracture of the knee that requires surgery.

You may qualify if:

• Subjects will be adult patients (over 18 years old)
• Patients must present with a unilateral closed intra-articular fracture of the knee.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27707, United States

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Steven Olson, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: February 15, 2013
• Study Start: October 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 19, 2016

Record last verified: 2015-08

Locations

US (1)