Prevention of Post-Traumatic Osteoarthritis (OA)
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ankle distraction permitting motion
Ankle distraction without motion
Sponsored by
About this trial
This is an interventional prevention trial for Osteoarthritis focused on measuring Osteoarthritis, Ankle, Ankle Distraction
Eligibility 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 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)
Sites / Locations
- Department of Orthopedics and Rehabilitation, University of Iowa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Group A participants will be treated with mechanical distraction with motion
Group B participants will be treated with mechanical distraction without motion
Outcomes
Primary Outcome Measures
Ankle Osteoarthritis Scale scores
CT data to measure cartilage distribution over the articular surface and synovial fluid markers of biosynthetic/degradative activity and oxidative stress in response to treatment and comparison to clinical and radiographic changes
Improved joint function
Secondary Outcome Measures
Full Information
NCT ID
NCT00054821
First Posted
February 11, 2003
Last Updated
March 16, 2017
Sponsor
Ned Amendola
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00054821
Brief Title
Prevention of Post-Traumatic Osteoarthritis (OA)
Official Title
Pathogenesis-Prevention of Post-Traumatic Osteoarthritis (OA): Effects of Distraction and Motion on OA
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ned Amendola
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Ankle, Ankle Distraction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A participants will be treated with mechanical distraction with motion
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B participants will be treated with mechanical distraction without motion
Intervention Type
Procedure
Intervention Name(s)
Ankle distraction permitting motion
Intervention Description
External fixator is applied to ankle joint for 85 - 95 days; ankle motion is permitted
Intervention Type
Procedure
Intervention Name(s)
Ankle distraction without motion
Intervention Description
External fixator is applied to ankel joint for 85 - 95 days; ankle motion is not permitted
Primary Outcome Measure Information:
Title
Ankle Osteoarthritis Scale scores
Time Frame
Two years
Title
CT data to measure cartilage distribution over the articular surface and synovial fluid markers of biosynthetic/degradative activity and oxidative stress in response to treatment and comparison to clinical and radiographic changes
Time Frame
Two years
Title
Improved joint function
Time Frame
Two Years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A. Buckwalter, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas D. Brown, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedics and Rehabilitation, University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
14620787
Citation
Buckwalter JA. Sports, joint injury, and posttraumatic osteoarthritis. J Orthop Sports Phys Ther. 2003 Oct;33(10):578-88. doi: 10.2519/jospt.2003.33.10.578.
Results Reference
background
PubMed Identifier
15232420
Citation
Buckwalter JA, Brown TD. Joint injury, repair, and remodeling: roles in post-traumatic osteoarthritis. Clin Orthop Relat Res. 2004 Jun;(423):7-16.
Results Reference
background
Learn more about this trial
Prevention of Post-Traumatic Osteoarthritis (OA)
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