Prevention of Post-Traumatic Osteoarthritis (OA)
Completed · Not applicable
Conditions studied: Osteoarthritis
In brief
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.
Key facts
- Study ID
- NCT00054821
- Run by
- Ned Amendola
- People needed
- 40
- Starts
- 2002-11-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2017-03-17
Who can join
Age: any, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Symptomatic isolated ankle OA (unilateral Kellgren grade 3, 4, or 5)
- Skeletally mature (children included if they have no open growth plates)
- Failure of less than 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)
Where it is running
- Department of Orthopedics and Rehabilitation, University of Iowa — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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