Prevention of Post-Traumatic Osteoarthritis (OA)

NCT ID: NCT00054821

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2009-02-28

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Group A participants will be treated with mechanical distraction with motion

Group Type: EXPERIMENTAL

Ankle distraction permitting motion

Intervention Type: PROCEDURE

External fixator is applied to ankle joint for 85 - 95 days; ankle motion is permitted

Group B

Group B participants will be treated with mechanical distraction without motion

Group Type: ACTIVE_COMPARATOR

Ankle distraction without motion

Intervention Type: PROCEDURE

External fixator is applied to ankel joint for 85 - 95 days; ankle motion is not permitted

Interventions

Ankle distraction permitting motion

External fixator is applied to ankle joint for 85 - 95 days; ankle motion is permitted

Intervention Type: PROCEDURE

Ankle distraction without motion

External fixator is applied to ankel joint for 85 - 95 days; ankle motion is not permitted

Intervention Type: PROCEDURE

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)

• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Ned Amendola

OTHER

Sponsor Role: lead

Responsible Party

Ned Amendola

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joseph A. Buckwalter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Thomas D. Brown, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

Department of Orthopedics and Rehabilitation, University of Iowa

Iowa City, Iowa, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 14620787 (View on PubMed)

Buckwalter JA, Brown TD. Joint injury, repair, and remodeling: roles in post-traumatic osteoarthritis. Clin Orthop Relat Res. 2004 Jun;(423):7-16.

Reference Type: BACKGROUND

PMID: 15232420 (View on PubMed)

Other Identifiers

P50AR048939

Identifier Type: NIH

Identifier Source: secondary_id

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NIAMS-082

Identifier Type: -

Identifier Source: secondary_id

P50AR048939

Identifier Type: NIH

Identifier Source: org_study_id

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