NCT00054821

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2003

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

6.3 years

First QC Date

February 11, 2003

Last Update Submit

March 16, 2017

Conditions

Osteoarthritis

Keywords

Osteoarthritis, AnkleAnkle Distraction

Outcome Measures

Primary Outcomes (3)

  • Ankle Osteoarthritis Scale scores

    Two years

  • 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

    Two years

  • Improved joint function

    Two Years

Study Arms (2)

Group A

EXPERIMENTAL

Group A participants will be treated with mechanical distraction with motion

Procedure: Ankle distraction permitting motion

Group B

ACTIVE COMPARATOR

Group B participants will be treated with mechanical distraction without motion

Procedure: Ankle distraction without motion

Interventions

Ankle distraction permitting motionPROCEDURE

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

Group A
Ankle distraction without motionPROCEDURE

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

Group B

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedics and Rehabilitation, University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

  • 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.

    PMID: 14620787BACKGROUND

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

    PMID: 15232420BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Motion

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Joseph A. Buckwalter, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • Thomas D. Brown, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2003

First Posted

February 13, 2003

Study Start

November 1, 2002

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

March 17, 2017

Record last verified: 2017-03

Locations

US(1)