NCT02984254

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable knee-osteoarthritis

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

First Submitted

Initial submission to the registry

October 31, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

December 20, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

October 31, 2016

Last Update Submit

January 23, 2019

Conditions

Knee OsteoarthritisMetabolic Disease

Keywords

kneeknee osteoarthritisBracingpatellofemoral osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Evaluate improvement in function

    Apply the Lequesne questionnaire

    baseline and 3 months

Secondary Outcomes (5)

  • Improvement in pain

    baseline, 1 month, 3 months and 1 year

  • Improvement in stiffness

    baseline, 1 month, 3 months and 1 year

  • Improvement in function with the TUG (Timed-Up-and-Go)

    baseline, 1 month, 3 months and 1 year

  • Improvement in function with Five-Times-Sit-To-Stand-Test (FTSST)

    baseline, 1 month, 3 months and 1 year

  • Improvement in function with six minute walk test

    baseline, 1 month, 3 months and 1 year

Study Arms (2)

functional patellofemoral neoprene brace

EXPERIMENTAL

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: WomacDevice: LequesneDevice: Timed-up-and-go (TUG)Device: five-times-sit-to-stand-test (FTSST)Device: Six-minute walk test.Device: functional patellofemoral neoprene brace

neoprene sleeve brace.

EXPERIMENTAL

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: WomacDevice: LequesneDevice: Timed-up-and-go (TUG)Device: five-times-sit-to-stand-test (FTSST)Device: Six-minute walk test.Device: neoprene sleeve brace.

Interventions

WomacDEVICE

Answer Womac questionnaires at baseline, 1 month, 3 months and 1 year

functional patellofemoral neoprene braceneoprene sleeve brace.
LequesneDEVICE

Answer Lequesne questionnaires at baseline, 1 month, 3 months and 1 year

functional patellofemoral neoprene braceneoprene sleeve brace.
Timed-up-and-go (TUG)DEVICE

Perform Timed-up-and-go (TUG) at baseline, 1 month, 3 months and 1 year

functional patellofemoral neoprene braceneoprene sleeve brace.
five-times-sit-to-stand-test (FTSST)DEVICE

Perform the five-times-sit-to-stand-test (FTSST) at baseline, 1 month, 3 months and 1 year

functional patellofemoral neoprene braceneoprene sleeve brace.
Six-minute walk test.DEVICE

Perform six-minute walk test at baseline, 3 months and 1 year

functional patellofemoral neoprene braceneoprene sleeve brace.
functional patellofemoral neoprene braceDEVICE

Use the functional patellofemoral neoprene brace for 2 hours/day minimum - 12 hours/day maximum

functional patellofemoral neoprene brace
neoprene sleeve brace.DEVICE

Use the neoprene sleeve brace for 2 hours/day minimum - 12 hours/day maximum

neoprene sleeve brace.

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic knee OA (patellofemoral)

You may not qualify if:

  • Not using the brace as requested;
  • Study abandonment;
  • No adaptation to brace;
  • Skin and vascular complications by use of the brace;
  • Obesity class II, III or morbid;
  • Patients who cannot read or understand the informed consent or the WOMAC questionnaire;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. 2006 Nov;33(11):2271-9. Epub 2006 Oct 1.

    PMID: 17013996BACKGROUND

  • McAlindon T, Zhang Y, Hannan M, Naimark A, Weissman B, Castelli W, Felson D. Are risk factors for patellofemoral and tibiofemoral knee osteoarthritis different? J Rheumatol. 1996 Feb;23(2):332-7.

    PMID: 8882042BACKGROUND

  • Hunter DJ, Zhang YQ, Niu JB, Felson DT, Kwoh K, Newman A, Kritchevsky S, Harris T, Carbone L, Nevitt M. Patella malalignment, pain and patellofemoral progression: the Health ABC Study. Osteoarthritis Cartilage. 2007 Oct;15(10):1120-7. doi: 10.1016/j.joca.2007.03.020. Epub 2007 May 14.

    PMID: 17502158BACKGROUND

  • Kalichman L, Zhang Y, Niu J, Goggins J, Gale D, Felson DT, Hunter D. The association between patellar alignment and patellofemoral joint osteoarthritis features--an MRI study. Rheumatology (Oxford). 2007 Aug;46(8):1303-8. doi: 10.1093/rheumatology/kem095. Epub 2007 May 24.

    PMID: 17525117BACKGROUND

  • Hinman RS, Bennell KL, Crossley KM, McConnell J. Immediate effects of adhesive tape on pain and disability in individuals with knee osteoarthritis. Rheumatology (Oxford). 2003 Jul;42(7):865-9. doi: 10.1093/rheumatology/keg233. Epub 2003 Mar 31.

    PMID: 12730546BACKGROUND

  • Hinman RS, Crossley KM, McConnell J, Bennell KL. Efficacy of knee tape in the management of osteoarthritis of the knee: blinded randomised controlled trial. BMJ. 2003 Jul 19;327(7407):135. doi: 10.1136/bmj.327.7407.135.

    PMID: 12869456BACKGROUND

  • Cushnaghan J, McCarthy C, Dieppe P. Taping the patella medially: a new treatment for osteoarthritis of the knee joint? BMJ. 1994 Mar 19;308(6931):753-5. doi: 10.1136/bmj.308.6931.753.

    PMID: 8142829BACKGROUND

  • Crossley KM, Marino GP, Macilquham MD, Schache AG, Hinman RS. Can patellar tape reduce the patellar malalignment and pain associated with patellofemoral osteoarthritis? Arthritis Rheum. 2009 Dec 15;61(12):1719-25. doi: 10.1002/art.24872.

    PMID: 19950307BACKGROUND

  • McWalter EJ, Hunter DJ, Harvey WF, McCree P, Hirko KA, Felson DT, Wilson DR. The effect of a patellar brace on three-dimensional patellar kinematics in patients with lateral patellofemoral osteoarthritis. Osteoarthritis Cartilage. 2011 Jul;19(7):801-8. doi: 10.1016/j.joca.2011.03.003. Epub 2011 Mar 11.

    PMID: 21397707BACKGROUND

  • Hunter DJ, Harvey W, Gross KD, Felson D, McCree P, Li L, Hirko K, Zhang B, Bennell K. A randomized trial of patellofemoral bracing for treatment of patellofemoral osteoarthritis. Osteoarthritis Cartilage. 2011 Jul;19(7):792-800. doi: 10.1016/j.joca.2010.12.010. Epub 2011 Jan 11.

    PMID: 21232620BACKGROUND

  • Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.

    PMID: 3741515BACKGROUND

  • KELLGREN JH, LAWRENCE JS. Radiological assessment of rheumatoid arthritis. Ann Rheum Dis. 1957 Dec;16(4):485-93. doi: 10.1136/ard.16.4.485. No abstract available.

    PMID: 13498603BACKGROUND

  • McCarthy EK, Horvat MA, Holtsberg PA, Wisenbaker JM. Repeated chair stands as a measure of lower limb strength in sexagenarian women. J Gerontol A Biol Sci Med Sci. 2004 Nov;59(11):1207-12. doi: 10.1093/gerona/59.11.1207.

    PMID: 15602077BACKGROUND

  • Stratford PW, Kennedy DM, Woodhouse LJ. Performance measures provide assessments of pain and function in people with advanced osteoarthritis of the hip or knee. Phys Ther. 2006 Nov;86(11):1489-96. doi: 10.2522/ptj.20060002.

    PMID: 17079748BACKGROUND

  • de Campos GC, Rezende MU, Pailo AF, Frucchi R, Camargo OP. Adding triamcinolone improves viscosupplementation: a randomized clinical trial. Clin Orthop Relat Res. 2013 Feb;471(2):613-20. doi: 10.1007/s11999-012-2659-y. Epub 2012 Oct 26.

    PMID: 23100188BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoarthritis, KneeMetabolic Diseases

Interventions

Walk Test

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise TestHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Marcia U Rezende, MD; PhD

    Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; PhD

Study Record Dates

First Submitted

October 31, 2016

First Posted

December 6, 2016

Study Start

December 20, 2016

Primary Completion

October 30, 2018

Study Completion

December 30, 2018

Last Updated

January 25, 2019

Record last verified: 2019-01