Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effects of Specialized Footwear in Osteoarthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Arthritis Foundation
Information provided by (Responsible Party):
Najia Shakoor, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01597830
First received: May 10, 2012
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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 Intervention
Knee Osteoarthritis
Other: Mobility shoe
Other: control shoe

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Specialized Footwear in Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Dynamic knee loading [ Time Frame: 6 months to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: July 2007
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active shoe Other: Mobility shoe
flat, specialized shoe
Sham Comparator: Control Other: control shoe
control shoe

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01597830

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

Publications:
Responsible Party: Najia Shakoor, M.D., Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01597830     History of Changes
Other Study ID Numbers: L07041071
Study First Received: May 10, 2012
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
knee
osteoarthritis
loading

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

ClinicalTrials.gov processed this record on November 20, 2014