Study of How An Ankle Strap Changes Effects of Insole Treatment for Knee Osteoarthritis

Medial Compartment Knee Osteoarthritis Clinical Trial

Official title:

Immediate and Short-Term Analgesic and Biomechanical Effects of a Laterally Wedged Insole With Ankle Strapping for Medial Compartment Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331110
• Other study ID #: 200501707
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 26, 2006
• Last updated: December 20, 2007
• Start date: May 2006
• Est. completion date: August 2006

Study information

• Verified date: April 2007
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. Use of the insole with ankle strapping significantly alters hip-knee-ankle (HKA) angle towards 180° or talar valgus angulation.

2. Use of the insole with ankle strapping significantly reduces peak knee external varus moment during gait.

3. Use of the insole with ankle strapping significantly reduces foot external rotation (out-toeing) or widened base during gait analysis.

4. The radiographic HKA angle and tilt angle of the talus will predict knee peak external varus moment during gait.

Clinical Hypotheses

1. The use of an insole with ankle strapping over a two-week period will reduce knee pain (Visual analogue scale, and Knee Osteoarthritis Outcome Survey).

Description:

Osteoarthritis (OA) of the knee is a common cause of pain and disability and the medial compartment is involved most frequently. If conservative mechanical therapies could reduce knee OA symptoms, risks to patients might be minimized through reduction in use of pharmacotherapy or surgery. A lateral heel wedge with strapping of the ankle joint has been reported to induce a similar therapeutic effect to that of proximal tibial osteotomy. It is presumed that the mechanism for this involves correction of genu varum. However, the effects on the static lower limb mechanical axis and the dynamic knee adduction moment, a risk factor for knee OA symptoms and progression, have not been assessed, so the mechanism of effect is currently unknown. The proposed protocol would compare lower limb mechanical alignment (measured by radiographic hip-knee-ankle angle) and dynamic knee varus moment (measured by 3-dimensional gait analysis) with and without the strapped insole to further understanding of the mechanism of effect on subjects with knee OA. Additionally, this protocol would assess analgesia and whether use of the insole reduces known knee joint unloading compensatory mechanisms during gait. Through measurement of radiographic lower limb alignment, dynamic knee varus moment, and ankle/foot static and dynamic angles, a model would be developed relating radiographs with dynamic moments, potentially allowing greater risk stratification for knee OA development and progression through use of radiographs. In addition to elucidating the mechanism of effect of this insole and developing a model for radiographic interpretation, this protocol would be the fist study of this insole involving non-Japanese subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Potential subjects with a body mass index (BMI) of greater than 35 will be excluded to avoid the potential confounding effect of increased weight on the height of the insole. Other exclusion criteria will include: known injury or surgery involving bone or cartilage of the knee or ankle which may alter gait, history of factors which might alter response to use of a laterally wedged insole (e.g. greater or similar reduction in lateral compared with medial femorotibial jont space width on posterior-anterior radiographs, tibial osteotomy, congenital foot problems, fused joints, foot deformity, known limitation of range of motion of the subtalar joint), known neuromuscular disease, co-morbid disease which might confound gait analysis (e.g. hip OA, ankle OA, hallux rigidus, valgus deformity of the midfoot, other symptomatic deformity of the foot, advanced arthroplasty of the hindfoot, previous ankle arthrodesis, unable to walk without a gait aid), current use of an orthotic insole, inability to comply with study protocol.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medial Compartment Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Laterally-Wedged Insole with Ankle Strapping

• Laterally-Weged Insole

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
University of Iowa	Foundation for Physical Medicine and Rehabilitation, Physiatric Association of Spine, Sports and Occupational Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip-Knee-Ankle Alignment
Primary	Talar Tilt Angle
Primary	External Knee Adduction Moment
Primary	Pain Assessment
Primary	Gait Velocity
Secondary	Center of Pressure
Secondary	Foot Progression Angle