NCT01597830

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

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

July 1, 2007

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

6.1 years

First QC Date

May 10, 2012

Last Update Submit

April 4, 2016

Conditions

Knee Osteoarthritis

Keywords

kneeosteoarthritisloading

Outcome Measures

Primary Outcomes (1)

  • Dynamic knee loading

    6 months to 2 years

Study Arms (2)

active shoe

EXPERIMENTAL
Other: Mobility shoe

Control

SHAM COMPARATOR
Other: control shoe

Interventions

Mobility shoeOTHER

flat, specialized shoe

active shoe
control shoeOTHER

control shoe

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

  • Shakoor N, Sengupta M, Foucher KC, Wimmer MA, Fogg LF, Block JA. Effects of common footwear on joint loading in osteoarthritis of the knee. Arthritis Care Res (Hoboken). 2010 Jul;62(7):917-23. doi: 10.1002/acr.20165.

    PMID: 20191571BACKGROUND

  • Shakoor N, Lidtke RH, Sengupta M, Fogg LF, Block JA. Effects of specialized footwear on joint loads in osteoarthritis of the knee. Arthritis Rheum. 2008 Sep 15;59(9):1214-20. doi: 10.1002/art.24017.

    PMID: 18759313BACKGROUND

  • Shakoor N, Block JA. Walking barefoot decreases loading on the lower extremity joints in knee osteoarthritis. Arthritis Rheum. 2006 Sep;54(9):2923-7. doi: 10.1002/art.22123.

    PMID: 16947448BACKGROUND

  • Shakoor N, Lidtke RH, Wimmer MA, Mikolaitis RA, Foucher KC, Thorp LE, Fogg LF, Block JA. Improvement in knee loading after use of specialized footwear for knee osteoarthritis: results of a six-month pilot investigation. Arthritis Rheum. 2013 May;65(5):1282-9. doi: 10.1002/art.37896.

    PMID: 23575871BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Najia Shakoor, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 14, 2012

Study Start

July 1, 2007

Primary Completion

August 1, 2013

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

US(1)