NCT00331110

Brief Summary

The goal of this project is to assess the effects of an ankle strap on the effectiveness of a laterally-wedged insole with ankle strapping in reducing knee symptoms and improving static and dynamic lower limb biomechanics. Using a repeated measures, modified cross-over design, the following aims and hypotheses will be addressed: Biomechanical Hypotheses

  1. 1.Use of the insole with ankle strapping significantly alters hip-knee-ankle (HKA) angle towards 180° or talar valgus angulation.
  2. 2.Use of the insole with ankle strapping significantly reduces peak knee external varus moment during gait.
  3. 3.Use of the insole with ankle strapping significantly reduces foot external rotation (out-toeing) or widened base during gait analysis.
  4. 4.The radiographic HKA angle and tilt angle of the talus will predict knee peak external varus moment during gait.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

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

May 1, 2006

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
2 months 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

January 3, 2008

Status Verified

April 1, 2007

Enrollment Period

3 months

First QC Date

May 26, 2006

Last Update Submit

December 20, 2007

Conditions

Medial Compartment Knee Osteoarthritis

Outcome Measures

Primary Outcomes (5)

  • Hip-Knee-Ankle Alignment

  • Talar Tilt Angle

  • External Knee Adduction Moment

  • Pain Assessment

  • Gait Velocity

Secondary Outcomes (2)

  • Center of Pressure

  • Foot Progression Angle

Interventions

Laterally-Wedged Insole with Ankle StrappingDEVICE
Laterally-Weged InsoleDEVICE

Eligibility Criteria

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

You may qualify if:

  • Subjects aged 45 or over will be included if they have predominantly medial compartment knee OA by American College of Rheumatology criteria, with medial knee pain rated at least 40/100mm on a visual analogue scale on most days of the month during one of the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Study Officials

  • Neil A Segal, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2006

First Posted

May 29, 2006

Study Start

May 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

January 3, 2008

Record last verified: 2007-04

Locations

US(1)