Prevention of Post-Traumatic Osteoarthritis (OA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ned Amendola, University of Iowa
ClinicalTrials.gov Identifier:
NCT00054821
First received: February 11, 2003
Last updated: August 2, 2013
Last verified: August 2013
  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 Intervention
Osteoarthritis
Procedure: Ankle distraction permitting motion
Procedure: Ankle distraction without motion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pathogenesis-Prevention of Post-Traumatic Osteoarthritis (OA): Effects of Distraction and Motion on OA

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Ankle Osteoarthritis Scale scores [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Improved joint function [ Time Frame: Two Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: November 2002
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Group A participants will be treated with mechanical distraction with motion
Procedure: Ankle distraction permitting motion
External fixator is applied to ankle joint for 85 - 95 days; ankle motion is permitted
Active Comparator: Group B
Group B participants will be treated with mechanical distraction without motion
Procedure: Ankle distraction without motion
External fixator is applied to ankel joint for 85 - 95 days; ankle motion is not permitted

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.

  Eligibility

Ages Eligible for Study:   up to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054821

Locations
United States, Iowa
Department of Orthopedics and Rehabilitation, University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Ned Amendola
Investigators
Principal Investigator: Joseph A. Buckwalter, MD University of Iowa
Principal Investigator: Thomas D. Brown, PhD University of Iowa
  More Information

Publications:
Responsible Party: Ned Amendola, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT00054821     History of Changes
Other Study ID Numbers: P50 AR48939, P50AR048939, NIAMS-082
Study First Received: February 11, 2003
Last Updated: August 2, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Iowa:
Osteoarthritis, Ankle
Ankle Distraction

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014