NCT00105365

Brief Summary

This trial will assess the ability of shoe inserts to relieve pain and disability in people with knee osteoarthritis (OA) in the inner (medial) aspect of the knee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

1.5 years

First QC Date

March 11, 2005

Last Update Submit

October 20, 2015

Conditions

Knee Osteoarthritis

Keywords

lateral wedge insertsshoe inserts

Outcome Measures

Primary Outcomes (1)

  • WOMAC pain scale

    6 months

Study Arms (2)

walking shoes

PLACEBO COMPARATOR

walking shoes

Other: walking shoes

walking shoes + shoe insert

EXPERIMENTAL

walking shoes + shoe insert

Device: Shoe insert

Interventions

Shoe insertDEVICE

Subjects with knee OA underwent gait analysis and knee pain and function assessment at baseline while wearing walking shoes and after four weeks of wearing walking shoes with lateral-wedged insoles.

walking shoes + shoe insert
walking shoesOTHER

walking shoes

walking shoes

Eligibility Criteria

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

You may qualify if:

  • Ability to walk 30 feet without a walking aid
  • Ability to stand unaided
  • Ability to understand verbal instructions
  • Ability to give informed consent

You may not qualify if:

  • History of knee trauma or surgery including arthroscopic surgery in the past 6 months
  • Severe obesity (\>30 kg/m2)
  • Neurological disease
  • Injury or amputation to the lower extremity joints
  • History of other types of arthritis
  • Symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee
  • Intra-articular steroids in the past 3 months, or hyaluronic acid in the last 6 months
  • Poor health that would impair compliance or assessment such as shortness of breath with exertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

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

  • Meika A Fang, MD

    VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2005

First Posted

March 14, 2005

Study Start

March 1, 2004

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

October 21, 2015

Record last verified: 2015-10

Locations

US(1)