Clinical Trial: Prevention of Post-Traumatic Osteoarthritis (OA)

This study is currently recruiting patients.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

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

Further Study Details: 
Primary Outcomes: Ankle Osteoarthritis Scale scores; SF-36 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
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.

Eligibility

Ages Eligible for Study:  up to  60 Years,  Genders Eligible for Study:  Both

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)

Location and Contact Information

Charles L. Saltzman, MD      319-356-7149    charles-saltzman@uiowa.edu
Mary P. Stolley, BSN      319-353-7504    patty-stolley@uiowa.edu

Iowa
      Department of Orthopedics and Rehabilitation, University of Iowa, Iowa City,  Iowa,  52242,  United States; Recruiting
Lois A. Lembke, MS  319-335-7548    lois-lembke@uiowa.edu 
Joseph A. Buckwalter, MD  319-356-2595    joseph-buckwalter@uiowa.edu 
Charles L. Saltzman, MD,  Principal Investigator
Annunziato Amendola, MD,  Sub-Investigator
Thomas D. Brown, PhD,  Sub-Investigator

Study chairs or principal investigators

Joseph A. Buckwalter, MD,  Principal Investigator,  University of Iowa   
Thomas D. Brown, PhD,  Principal Investigator,  University of Iowa   

More Information

Publications

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.

Study ID Numbers:  NIAMS-082; P50 AR48939
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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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