The Effects of Specialized Footwear in Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01597830
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : April 6, 2016
Arthritis Foundation
Information provided by (Responsible Party):
Najia Shakoor, Rush University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Mobility shoe Other: control shoe Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Specialized Footwear in Osteoarthritis
Study Start Date : July 2007
Actual Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: active shoe Other: Mobility shoe
flat, specialized shoe

Sham Comparator: Control Other: control shoe
control shoe

Primary Outcome Measures :
  1. Dynamic knee loading [ Time Frame: 6 months to 2 years ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01597830

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Arthritis Foundation
Principal Investigator: Najia Shakoor, MD Rush University Medical Center