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Home > "P" Clinical Trials Conditions > Prevention of Post-Traumatic Osteoarthritis (OA) Prevention of Post-Traumatic Osteoarthritis (OA)
Prevention of Post-Traumatic Osteoarthritis (OA)
For Condition: Osteoarthritis
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ,
Synopsis: Joint injury and trauma dramatically increase the risk of developing osteoarthritis (OA). The purpose of this study is to determine what factors lead to decreased pain, improved joint function, and repair of the joint surface in post-traumatic OA.
Details: Little work has been done on the pathogenesis and prevention of post-traumatic OA. The human ankle joint provides a unique opportunity for the study of post-traumatic OA because of the low risk of primary OA and the relatively high risk of post-traumatic OA. This study involves a multidisciplinary approach utilizing both laboratory and clinical research to improve understanding of OA and to develop innovative approaches for preventing and treating this disease. Mechanical distraction involves operative placement of specialized pins and rods to hold the joint in place. Some distraction allows for limited motion of the joint, while other distraction holds the joint immobile. The purpose of this study is to elucidate the mechanical factors that lead to restoration of a cartilaginous articular surface, decreased pain, and improved joint function after mechanical distraction of osteoarthritic joints. Participants in this study will be randomly assigned to one of two treatment groups. Group A will be treated with mechanical distraction with motion; Group B will be treated with mechanical distraction without motion. Participants will be followed for 28 months and will have 11 study visits. Most of the study visits will occur during the first half of the study. State-of-the-art techniques for clinical assessment, articular surface imaging, biomechanical modeling, and biochemical testing will be used in this study.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Symptomatic isolated ankle OA (unilateral Kellgren grade 3, 4, or 5) - Skeletally mature (children included if they have no open growth plates) - Failure of > 1 year nonoperative treatment, including 3 months of continuous treatment with nonsteroidal anti-inflammatory agents and 3 months of unloading treatment (i.e., unloading brace, crutches, cane, walker)
Total Enrollment: 56
Location and Contact Information:
Overall Study Official:
JosephBuckwalter, Principal Investigator, University of Iowa
Dept. of Orthopaedic Surgery, University of Iowa *Recruiting*
Iowa City, Iowa, 52242
United States
Recruiting Lois Lembke 319-335-7548
Additional Information:
Study ID Numbers: NIAMS-082; P50 AR48939
Study Start Date: November 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054821
Other Osteoarthritis Studies:
1. Prevention of Post-Traumatic Osteoarthritis (OA)
2. Patient Education in Rheumatoid Arthritis and Osteoarthritis
3. Osteoarthritis Initiative (OAI): A Knee Health Study
4. Aerobic Exercise Intervention for Knee Osteoarthritis
5. Doxycycline and OA Progression
Related Studies:
Other Osteoarthritis Clinical Trials
Other Iowa Clinical Trials
Other Iowa City Clinical Trials
Prevention of Post-Traumatic Osteoarthritis (OA)
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