The Effects of Specialized Footwear in Osteoarthritis

April 4, 2016 updated by: Najia Shakoor, Rush University Medical Center
This study evaluates the effects of specialized footwear on pain and knee loading in knee osteoarthritis. The hypothesis is that this footwear will lead to decreased knee loading and knee pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able and willing to give informed consent and to comply with the study protocol and follow-up instructions.
  • Symptomatic OA of the knee, as defined by the American College of Rheumatology's Clinical Criteria for Classification and Reporting of OA of the Knee. If symptoms are bilateral, then the knee identified by the subject as more symptomatic will serve as the index knee.
  • Ambulatory knee pain, defined as the presence of greater than 30 mm of pain while walking on a flat surface (corresponding to question 1 of the visual analog format of the WOMAC.
  • Radiographic OA of the study knee of grade 2 or 3, as defined by the modified Kellgren and Lawrence (K-L) grading scale.
  • Medial compartment OA, defined as either qualitative joint space narrowing of ≥ 1or the presence of medial bone cyst, sclerosis, or osteophyte.

Exclusion Criteria:

  • Inability or unwillingness to wear study shoes for at least 6 hours/day for 6 days/week
  • Knee flexion contracture of > 15 degrees or inability to ambulate without assistance.
  • Presence of clinically significant OA of the hip or ankle or pain greater than 20 mm at these sites (WOMAC).
  • > 3 degrees valgus or >12 degrees varus deformity of either knee, defined by the mechanical axis (hip-knee angle).
  • Predominant lateral compartment OA, defined as narrowing of the lateral joint space in excess of the narrowing of the medial joint space in either the index or the contralateral knee.
  • Concurrent systemic inflammatory arthropathy,
  • Prior knee or hip arthroplasty, or surgical arthroscopy of either knee within previous 3 months or history of fracture of either lower extremity within 6 months of study entry.
  • Intrinsic foot disease including hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated by particular footwear.
  • Intra-articular injection in the index knee: steroids within 6 weeks, hyaluronan derivatives within 4 months.
  • Pregnant subjects will be excluded because of the X-rays required.
  • Any medical condition that, in the opinion of the PI, would render the subject unable to complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Control
Other: control shoe
control shoe
EXPERIMENTAL: active shoe
Other: Mobility shoe
flat, specialized shoe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dynamic knee loading
Time Frame: 6 months to 2 years
6 months to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Collaborators

Arthritis Foundation

Investigators

  • Principal Investigator: Najia Shakoor, MD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (ESTIMATE)

May 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L07041071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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