Prevention of Post-Traumatic Osteoarthritis (OA) - Article Degenerative Joint Disease; Osteoarthritis arthritis
Clinical Trial: Prevention of Post-Traumatic Osteoarthritis (OA)
This study is currently recruiting patients.
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.
Study hypotheses: 1) Ankle motion during distraction will result in clinically significant improvements in Ankle Osteoarthritis Scale scores, SF-36 scores, and improved cartilage thickness distribution over the habitually most heavily loaded portion of the articular surface, as compared to the use of distraction without ankle motion. 2a) Ankles with low geometric surface irregularity and greater range of motion will have better preservation of neo-chondroid tissue (increased normalized cartilage thickness and reduced longitudinal compressive strain in the habitually heavily regions of the articular surface) than those with high surface irregularity. 2b) Low geometric surface irregularity and greater range of motion will have reduced habitual focal or regional contact stress elevation. 3) Joints that have better improvements in Ankle Osteoarthritis Scale scores and improved cartilage thickness distribution over habitually heavily loaded portion of the articular surface will have improved normalization of synovial fluid markers of biosynthetic/degradative activity and oxidative stress.
|Condition||Treatment or Intervention|
|Osteoarthritis || Procedure: Fixed ankle distraction |
Procedure: Ankle distraction permitting motion
MedlinePlus related topics: Osteoarthritis
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Pathogenesis-Prevention of Post-Traumatic Osteoarthritis (OA): Effects of Distraction and Motion on OA
Expected Total Enrollment: 56
Study start: November 2002
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.
Ages Eligible for Study: up to 60 Years, Genders Eligible for Study: Both
- 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)
Location and Contact Information
Mary P. Stolley, BSN 319-353-7504 firstname.lastname@example.org
Department of Orthopedics and Rehabilitation, University of Iowa, Iowa City, Iowa, 52242, United States; Recruiting
Joseph A. Buckwalter, MD 319-356-2595 email@example.com
Charles L. Saltzman, MD, Principal Investigator
Annunziato Amendola, MD, Sub-Investigator
Thomas D. Brown, PhD, Sub-Investigator
Joseph A. Buckwalter, MD, Principal Investigator, University of Iowa
Thomas D. Brown, PhD, Principal Investigator, University of Iowa
Buckwalter JA. Sports, joint injury, and posttraumatic osteoarthritis. J Orthop Sports Phys Ther. 2003 Oct;33(10):578-88.
Buckwalter JA, Brown TD. Joint injury, repair, and remodeling: roles in post-traumatic osteoarthritis. Clin Orthop. 2004 Jun;(423):7-16.
Record last reviewed: March 2005
Last Updated: April 7, 2005
Record first received: February 11, 2003
ClinicalTrials.gov Identifier: NCT00054821
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005