Knee OsteoarthritisNCT02984254
Bracing for Patellofemoral Osteoarthritis
A study testing Womac, Lequesne and Timed-up-and-go (TUG) in people with Knee Osteoarthritis and Metabolic Disease, run by University of Sao Paulo General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Metabolic Disease
- What is being tested?
- Womac, Lequesne and Timed-up-and-go (TUG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2016to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic knee OA (patellofemoral)
Who cannot join
- 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;
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Metabolic Disease
- Being tested
- Womac, Lequesne, Timed-up-and-go (TUG), five-times-sit-to-stand-test (FTSST), Six-minute walk test.
- Keywords
- knee, knee osteoarthritis, Bracing, patellofemoral osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WomacDevice
Answer Womac questionnaires at baseline, 1 month, 3 months and 1 year
LequesneDevice
Answer Lequesne questionnaires at baseline, 1 month, 3 months and 1 year
Timed-up-and-go (TUG)Device
Perform Timed-up-and-go (TUG) at baseline, 1 month, 3 months and 1 year
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
Six-minute walk test.Device
Perform six-minute walk test at baseline, 3 months and 1 year
functional patellofemoral neoprene braceDevice
Use the functional patellofemoral neoprene brace for 2 hours/day minimum - 12 hours/day maximum
neoprene sleeve brace.Device
Use the neoprene sleeve brace for 2 hours/day minimum - 12 hours/day maximum
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Womac; Device: Lequesne; Device: 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. Receives: Device: Womac; Device: Lequesne; Device: Timed-up-and-go (TUG); Device: five-times-sit-to-stand-test (FTSST); Device: Six-minute walk test.; Device: neoprene sleeve brace. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate improvement in function
Apply the Lequesne questionnaire
Measured: baseline and 3 months
Secondary outcomes (5)
Improvement in pain
Apply the WOMAC questionnaire
Measured: baseline, 1 month, 3 months and 1 year
Improvement in stiffness
Apply the WOMAC questionnaire
Measured: baseline, 1 month, 3 months and 1 year
Improvement in function with the TUG (Timed-Up-and-Go)
Apply TUG (Time-up-Go test)
Measured: baseline, 1 month, 3 months and 1 year
Improvement in function with Five-Times-Sit-To-Stand-Test (FTSST)
Apply Five-Times-Sit-To-Stand-Test (FTSST)
Measured: baseline, 1 month, 3 months and 1 year
Improvement in function with six minute walk test
Apply six minute walk test
Measured: baseline, 1 month, 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start20 Dec 2016
- Primary completion30 Oct 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcia Uchoa Rezende, University of Sao Paulo General Hospital
- Investigators
- Marcia U Rezende, MD; PhD, Principal investigator, Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984254
- Sponsor's protocol ID
- 15016/16
- Status last verified
- Jan 2019
- First submitted
- 31 Oct 2016
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17013996McAlindon 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.
PubMed 8882042Hunter 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.
PubMed 17502158Kalichman 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.
PubMed 17525117Hinman 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.
PubMed 12730546Hinman 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.
PubMed 12869456Cushnaghan 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.
PubMed 8142829Crossley 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.
PubMed 19950307McWalter 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.
PubMed 21397707Hunter 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.
PubMed 21232620Altman 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.
PubMed 3741515KELLGREN 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.
PubMed 13498603McCarthy 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.
PubMed 15602077Stratford 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.
PubMed 17079748de 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.
PubMed 23100188
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bracing for Patellofemoral Osteoarthritis. A Prospective Randomized Study of the Treatment of Patellofemoral Arthritis by an Orthosis
- ClinicalTrials.gov ID
- NCT02984254
- Acronym / sponsor ID
- 15016/16
- Conditions
- Knee Osteoarthritis, Metabolic Disease
- Keywords
- knee, knee osteoarthritis, Bracing, patellofemoral osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| functional patellofemoral neoprene brace | Experimental | Device: Womac, Device: Lequesne, Device: Timed-up-and-go (TUG), Device: five-times-sit-to-stand-test (FTSST), Device: Six-minute walk test., Device: functional patellofemoral neoprene brace26 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. |
| neoprene sleeve brace. | Experimental | Device: Womac, Device: Lequesne, Device: Timed-up-and-go (TUG), Device: five-times-sit-to-stand-test (FTSST), Device: Six-minute walk test., Device: 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic knee OA (patellofemoral)
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WomacAnswer Womac questionnaires at baseline, 1 month, 3 months and 1 year | Device | functional patellofemoral neoprene brace, neoprene sleeve brace. |
| LequesneAnswer Lequesne questionnaires at baseline, 1 month, 3 months and 1 year | Device | functional patellofemoral neoprene brace, neoprene sleeve brace. |
| Timed-up-and-go (TUG)Perform Timed-up-and-go (TUG) at baseline, 1 month, 3 months and 1 year | Device | functional patellofemoral neoprene brace, neoprene sleeve brace. |
| 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 | functional patellofemoral neoprene brace, neoprene sleeve brace. |
| Six-minute walk test.Perform six-minute walk test at baseline, 3 months and 1 year | Device | functional patellofemoral neoprene brace, neoprene sleeve brace. |
| functional patellofemoral neoprene braceUse the functional patellofemoral neoprene brace for 2 hours/day minimum - 12 hours/day maximum | Device | functional patellofemoral neoprene brace |
| neoprene sleeve brace.Use the neoprene sleeve brace for 2 hours/day minimum - 12 hours/day maximum | Device | neoprene sleeve brace. |
Primary outcome
Evaluate improvement in function
Time frame: baseline and 3 months
Apply the Lequesne questionnaire
5 secondary outcomes
Improvement in pain
Time frame: baseline, 1 month, 3 months and 1 year
Improvement in stiffness
Time frame: 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
Improvement in function with Five-Times-Sit-To-Stand-Test (FTSST)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Background: PubMed 17013996Dillon 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.
- Background: PubMed 8882042McAlindon 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.
- Background: PubMed 17502158Hunter 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.
- Background: PubMed 17525117Kalichman 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.
- Background: PubMed 12730546Hinman 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.
- Background: PubMed 12869456Hinman 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.
- Background: PubMed 8142829Cushnaghan 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.
- Background: PubMed 19950307Crossley 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.
- Background: PubMed 21397707McWalter 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.
- Background: PubMed 21232620Hunter 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.
- Background: PubMed 3741515Altman 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.
- Background: PubMed 13498603KELLGREN 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.
- PARQVE - Project Arthritis Recovering Quality of Life by means of Education. Short-term outcome in a randomized clinical trialLink provided by the sponsor.
- . Analysis of anthropometric measures and dietary intake in patients undergoing a multi-professional osteoarthritis education program (PARQVE - Project Arthritis Recovering Quality of Life by means of EducationLink provided by the sponsor.
- Translation and cultural validation of the Lequesne's algofunctional questionnaire for osteoarthritis of knee and hip for portuguese languageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia U Rezende, MD; PhD principal investigator
Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Womac, Lequesne and Timed-up-and-go (TUG) in people with Knee Osteoarthritis and Metabolic Disease, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate improvement in function (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02984254, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.