Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

NCT01739296 | Completed

• 1 other identifier: 839/2011
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment.

Conditions

Osteoarthritis

Keywords

osteoarthritis; osteoarthritis, knee; foot orthoses; orthotic insoles

Outcome Measures

Primary Outcomes (1)

• Symptoms

  Evaluation of patient's symptoms using WOMAC (western ontario and mcmaster universities osteoarthritis index), VAS (visual analogic scale of pain) and Lequesne questionaires

  24 weeks

Secondary Outcomes (1)

• Ankle pain

  24 weeks

Study Arms (2)

Wedge

EXPERIMENTAL

Lateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily

Other: Lateral wedge insole with subtalar strapping

Neutral

SHAM COMPARATOR

Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily

Other: Neutral insole with subtalar strapping (sham)

Interventions

Neutral insole with subtalar strapping (sham) OTHER

Neutral insole with subtalar strapping (sham)

Also known as: Neutral

Neutral

Lateral wedge insole with subtalar strapping OTHER

Lateral wedge insole with subtalar strapping

Also known as: Wedge

Wedge

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the American College of Rheumatology criteria for knee Osteoarthritis
• Varus malalignment of the knee
• Absence of previous fracture on the index knee
• Absence of previous surgery on the index knee
• Absence of Rheumatoid Arthritis
• No Intra-articular injection on the index knee in the past 6 months
• Receiving usual care for Osteoarthritis for at least 6 months
• Be able to understand and agree with the informed consent

You may not qualify if:

• Undergo surgery during the study
• Undergo Intra-articular injection during the study
• Develop articular infection of the index joint during the study

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto de Ortopedia e Traumatologia HC-FMUSP

São Paulo, São Paulo, 05410-000, Brazil

Location

Related Links

• Brazilian Orthopaedics Association
• Orthopaedics and Traumatology Institute website
• University of São Paulo website
• Brazilian Knee Surgery Association website

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Gustavo C Campos, MD

  FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: December 3, 2012
• Study Start: June 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 11, 2013

Record last verified: 2013-09

Locations

BR (1)