NCT00076453

Brief Summary

Osteoarthritis is a degenerative joint disease and is the most common form of arthritis. This study will evaluate the effectiveness of customized shoe inserts in controlling and relieving the pain of knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 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

June 1, 2003

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

4.5 years

First QC Date

January 22, 2004

Last Update Submit

September 26, 2011

Conditions

Osteoarthritis

Keywords

Knee PainDegenerative ArthritisCartilage DiseaseNon-drug Therapy

Outcome Measures

Primary Outcomes (1)

  • Pain reduction

    Years 2 and 3

Secondary Outcomes (1)

  • Reduction in loading of the medial knee

    Years 2 and 3

Study Arms (2)

1

EXPERIMENTAL

Participants will wear lateral wedge orthotic inserts.

Device: Lateral wedge orthotic shoe inserts

2

ACTIVE COMPARATOR

Participants will wear standard orthotic inserts.

Device: Standard orthotic shoe inserts

Interventions

Lateral wedge orthotic shoe insertsDEVICE

Customized lateral wedge orthotic shoe inserts

1
Standard orthotic shoe insertsDEVICE

Neutral orthotic inserts

2

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 and radiographic OA of the knee
  • Knee pain upon walking
  • Predominant medial compartment OA

You may not qualify if:

  • Knee flexion contracture of greater than 15 degrees or inability to walk without assistance
  • Predominant lateral compartment OA of either knee
  • Greater than 3 degree valgus or greater than 12 degree varus deformity of either knee, as defined by the mechanical axis
  • Clinically evident OA of the ankle or hip
  • Clinically significant intrinsic foot disease upon podiatric evaluation, including any foot condition that may be aggravated by wearing orthotics
  • Substantial obesity, defined as having body mass index (BMI) greater than 35
  • Anticipation of surgery involving any joint of either lower extremity in the next 3 years
  • Habitual use of inappropriate shoewear that would interfere with adequate use of the orthotic inserts
  • Inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout
  • Chronic infection in any joint of the lower extremities
  • History of fracture of either lower extremity within 6 months of study entry
  • History of knee or hip arthroplasty or of surgical arthroscopy of either knee within 3 months of study entry
  • History of intra-articular injections (glucocorticoids or hyaluronic acid derivatives) in the index knee within 6 months of study entry
  • Pregnancy
  • Any medical condition which, in the opinion of the investigator, would render the patient unable to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center, Section of Rheumatology

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Tezcan ME, Goker B, Lidtke R, Block JA. Long-term effects of lateral wedge orthotics on hip and ankle joint space widths. Gait Posture. 2017 Jan;51:36-40. doi: 10.1016/j.gaitpost.2016.09.017. Epub 2016 Sep 21.

    PMID: 27693959DERIVED

MeSH Terms

Conditions

OsteoarthritisCartilage Diseases

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Joel A. Block, MD

    Rush University Medical Center, Section of Rheumatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2004

First Posted

January 26, 2004

Study Start

June 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

US(1)