NCT00506714

Brief Summary

The purpose of this study is to determine whether or not the use of a nonpharmacologic intervention (single point cane) is effective in the treatment of knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

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
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

September 28, 2012

Completed
Last Updated

October 4, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

July 20, 2007

Results QC Date

February 6, 2012

Last Update Submit

September 28, 2012

Conditions

Keywords

OsteoarthritisWalking SticksCanes

Outcome Measures

Primary Outcomes (1)

  • Gait Velocity

    Baseline

Secondary Outcomes (2)

  • Gait Velocity With a Cane in Hip OA Subjects

    Baseline

  • Gait Velocity

    4 weeks

Study Arms (2)

Adult subjects with hip osteoarthritis

EXPERIMENTAL

Walk with and without a single point cane at baseline and after four weeks

Device: single point cane

Healthy Subjects

NO INTERVENTION

Healthy adults walking without a cane at baseline

Interventions

Adjustable single point cane with SureGrip handle

Adult subjects with hip osteoarthritis

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hip OA (grades II-IV) of the Kellgren/Lawrence classification
  • with pain in one hip for most days of the prior month
  • Ability to walk 30 feet without postural sway
  • Ability to stand unaided
  • Ability to understand verbal instructions
  • Ability to give informed consent

You may not qualify if:

  • History of hip or knee trauma or surgery including arthroscopic surgery in the past six months
  • Severe obesity (\> 300 pounds)
  • Neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy, vestibular dysfunction or poor vision
  • Injury or amputation to the lower extremity joints
  • History of other types of arthritis or fibromyalgia
  • Pain from spine, knee, ankle, or foot disease that would interfere with assessment of the hip
  • Poor health that would impair compliance or assessment such as shortness of breath with exertion, chest pain
  • Foot deformities such as hallux rigidus, valgus deformity of the midfoot, previous ankle arthrodesis
  • Greater trochanteric pain syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA West Los Angeles

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Meika A. Fang, MD
Organization
Arthritis Foundation

Study Officials

  • Meika A Fang, MD

    VA Greater Los Angeles Healthcare System Department of Medicine; UCLA Department of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rheumatology

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 25, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

October 4, 2012

Results First Posted

September 28, 2012

Record last verified: 2012-09

Locations