Bracing for Patellofemoral Osteoarthritis

January 23, 2019 updated by: Marcia Uchoa Rezende, University of Sao Paulo General Hospital

Bracing for Patellofemoral Osteoarthritis. A Prospective Randomized Study of the Treatment of Patellofemoral Arthritis by an Orthosis

BACKGROUND: Despite the prevalence of patellofemoral ostearthritis (OA), this joint has received relatively little attention in the OA literature and there are few treatment options for individuals with patellofemoral OA. Patellar misalignment is associated with radiographic progression patellofemoral OA and symptoms and in magnetic resonance imaging (MRI), to cartilage loss measurements and bone marrow lesions. The hypothesis is that the correction of the patella disorder using strategies such as bracing or adhesive bandages can handle the symptoms and progression of OA.

OBJECTIVE: To compare the effect of a brace designed to stabilize the patellofemoral joint compared with a neoprene sleeve with kneecap opening in patients with patellofemoral OA.

METHODS: Fifty-two patients with patellofemoral OA and co-morbidities (Two or more of: overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will be divided into two groups according to the knee brace that will receive: Functional Bracing patellofemoral (group 1) and neoprene knee sleeve with patella opening (group 2). Both groups will be oriented on the clinical treatment of osteoarthritis and metabolic syndrome and asked to do daily exercises in addition to reporting the daily consumption of drugs a month before placing the orthotics up to three months after placing it. They will be evaluated with the questionnaires WOMAC and Lequesne, and asked to perform the five-times-sit-to-stand-test, Timed-up-and-go (TUG) and the six-minute walk test in the moments immediately prior to placement of the brace, with one, three and after 12 months bracing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients that sign the informed consent will be randomized and asked to participate in a 4-hour course about knee osteoarthritis. They will be sent home with a form to fill in all medications consumed daily for a month. They will return to the hospital where according to data given by www.randomization.com, they will receive one of two braces in one or both knees depending on their symptoms.

The functional brace has medial, lateral, superior and inferior "ruber bands" that should center patella in the patella groove. The other traditional neoprene sleeve brace with a patellar opening also tries to do the same with no other reinforcement other than the neoprene sleeve.

Prior to bracing, patients will deliver the prior month medication form, answer WOMAC and Lequesne questionnaires, and perform TUG, FTSST and the six-minute walk test.

They will be instructed to use the brace for 2 hours in the first day increasing half an hour per day up to a maximum of 12 hours/day. In case of difficulties with the brace for 12 continuous hours, they will be allowed to use it for at least 4 hours with a 2 hours interval and then again returning to bracing. Patients should sleep/rest without the brace(s). They should use their braces during physical activities unless if under water.

The primary objective is to evaluate and compare the short-term benefits of knee stabilization and compression. Therefore, the follow-up assessments, will be made prior to bracing and after one and three months. The evaluation will include the delivery of the registration of medications consumed daily (along with the hours of use of the orthosis), the WOMAC and Lequesne questionnaires and functional evaluations. X-rays without the braces (Front Schuss, profile and Axial) for measurement of affected joint spaces will be made before inclusion and after one year. Panoramic X-rays of the lower limbs will be performed before inclusion to measure the internal and external femoral-tibial angle. Complaints (pain, slip, swelling, skin lesions) and satisfaction (decrease pain, mobility improvement) with the use of the brace will be sought at each encounter. Patients will be asked about their weekly physical activity (intensity, type and hours of physical activity) on any adverse effects when using orthotics. Weight and height will be measured and each assessment to calculate BMI.

The secondary objective is the improvement in pain, stiffness and long-term function (1 year). Therefore, after a brief analysis of the results of three months, if there is a clinically significant difference between the groups, all patients will use the brace with best results. Therefore the study will be a case series. If both groups show clinically relevant improvements with no significant differences between the orthotics, the study will remain with two arms and the same clinical assessments, questionnaires, functional and radiographic one year. If none of the groups show a clinically relevant improvement in three months, the study will be terminated. Adverse effects of the use of orthotics will also be recorded in the one-year visit. All patients will be advised to discontinue use of the braces and telephone to our secretary in case of any adverse effects in the period between the official evaluations for proper conduct.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with symptomatic knee OA (patellofemoral)
  • Exclusion Criteria:
  • Not using the brace as requested;
  • Study abandonment;
  • No adaptation to brace;
  • Skin and vascular complications by use of the brace;
  • Failure to complete the consumption of drugs between inclusion and bracing;
  • Obesity class II, III or morbid;
  • Patients who cannot read or understand the informed consent or the WOMAC questionnaire;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: functional patellofemoral neoprene brace
26 Patients will use a a functional patellofemoral neoprene brace and answer WOMAC, Lequesne questionnaires, perform Timed-up-and-go (TUG), five-times-sit-to-stand-test (FTSST) and the six-minute walk test.
Device: Womac
Answer Womac questionnaires at baseline, 1 month, 3 months and 1 year
Device: Lequesne
Answer Lequesne questionnaires at baseline, 1 month, 3 months and 1 year
Device: Timed-up-and-go (TUG)
Perform Timed-up-and-go (TUG) at baseline, 1 month, 3 months and 1 year
Device: five-times-sit-to-stand-test (FTSST)
Perform the five-times-sit-to-stand-test (FTSST) at baseline, 1 month, 3 months and 1 year
Device: Six-minute walk test.
Perform six-minute walk test at baseline, 3 months and 1 year
Device: functional patellofemoral neoprene brace
Use the functional patellofemoral neoprene brace for 2 hours/day minimum - 12 hours/day maximum
Experimental: neoprene sleeve brace.
26 Patients will use a neoprene sleeve brace and answer WOMAC, Lequesne questionnaires, perform Timed-up-and-go (TUG), five-times-sit-to-stand-test (FTSST) and the six-minute walk test.
Device: Womac
Answer Womac questionnaires at baseline, 1 month, 3 months and 1 year
Device: Lequesne
Answer Lequesne questionnaires at baseline, 1 month, 3 months and 1 year
Device: Timed-up-and-go (TUG)
Perform Timed-up-and-go (TUG) at baseline, 1 month, 3 months and 1 year
Device: five-times-sit-to-stand-test (FTSST)
Perform the five-times-sit-to-stand-test (FTSST) at baseline, 1 month, 3 months and 1 year
Device: Six-minute walk test.
Perform six-minute walk test at baseline, 3 months and 1 year
Device: neoprene sleeve brace.
Use the neoprene sleeve brace for 2 hours/day minimum - 12 hours/day maximum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate improvement in function
Time Frame: baseline and 3 months
Apply the Lequesne questionnaire
baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in pain
Time Frame: baseline, 1 month, 3 months and 1 year
Apply the WOMAC questionnaire
baseline, 1 month, 3 months and 1 year
Improvement in stiffness
Time Frame: baseline, 1 month, 3 months and 1 year
Apply the WOMAC questionnaire
baseline, 1 month, 3 months and 1 year
Improvement in function with the TUG (Timed-Up-and-Go)
Time Frame: baseline, 1 month, 3 months and 1 year
Apply TUG (Time-up-Go test)
baseline, 1 month, 3 months and 1 year
Improvement in function with Five-Times-Sit-To-Stand-Test (FTSST)
Time Frame: baseline, 1 month, 3 months and 1 year
Apply Five-Times-Sit-To-Stand-Test (FTSST)
baseline, 1 month, 3 months and 1 year
Improvement in function with six minute walk test
Time Frame: baseline, 1 month, 3 months and 1 year
Apply six minute walk test
baseline, 1 month, 3 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Marcia U Rezende, MD; PhD, Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2016

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15016/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Womac

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe