Prevention of Post-Traumatic Osteoarthritis (OA)
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | Any - 60 |
| Updated: | 3/18/2017 |
| Start Date: | November 2002 |
| End Date: | February 2009 |
Pathogenesis-Prevention of Post-Traumatic Osteoarthritis (OA): Effects of Distraction and Motion on OA
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.
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.
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.
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.
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 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)
We found this trial at
1
site
200 Hawkins Drive
Iowa City, Iowa 52242
Iowa City, Iowa 52242
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