NCT00032240

Brief Summary

This trial will test shoe inserts for the treatment of knee osteoarthritis, the most common form of knee arthritis. Those with disease on the inner (medial) aspect of the knee will be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_3

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

February 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2002

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

4.5 years

First QC Date

March 12, 2002

Last Update Submit

June 2, 2013

Conditions

Osteoarthritis, Knee

Keywords

Biomechanics

Interventions

Shoe InsertDEVICE

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medial knee osteoarthritis
  • Pain
  • No foot problems
  • Lives in Boston, Massachusetts Metro area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (3)

  • Kerrigan DC, Lelas JL, Goggins J, Merriman GJ, Kaplan RJ, Felson DT. Effectiveness of a lateral-wedge insole on knee varus torque in patients with knee osteoarthritis. Arch Phys Med Rehabil. 2002 Jul;83(7):889-93. doi: 10.1053/apmr.2002.33225.

    PMID: 12098144BACKGROUND

  • Goggins J, Baker K, Felson D. What WOMAC pain score should make a patient eligible for a trial in knee osteoarthritis? J Rheumatol. 2005 Mar;32(3):540-2.

    PMID: 15742450BACKGROUND

  • Baker K, Goggins J, Xie H, Szumowski K, LaValley M, Hunter DJ, Felson DT. A randomized crossover trial of a wedged insole for treatment of knee osteoarthritis. Arthritis Rheum. 2007 Apr;56(4):1198-203. doi: 10.1002/art.22516.

    PMID: 17393448DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • David T. Felson, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2002

First Posted

March 13, 2002

Study Start

February 1, 2002

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)