The Knee Usual Care Evaluation Study (KUCE)
29 de novembro de 2017 atualizado por: Hospital for Special Surgery, New York
Title: The Study of Intra-articular Interventions of Platelet Rich Plasma or Hyaluronic Acid Compounds vs. Usual Care (Exercise/Diet/Supplements) in the Medical Management of Knee OA- Effects on Pain and Function; Effects on Articular Cartilage; Effects on Time to Partial or Total Knee Arthroplasty: The Knee Usual Care Evaluation (KUCE) Study
The purpose of this prospective data collection is to track patients who are treated at HSS who are confirmed with knee osteoarthritis. The registry will collect prospective patient related and functional outcomes (including use of assistive devices), medication use and imaging data on patients with confirmed osteoarthritis, and the effect of different medical interventions that include PRP, Synvisc / Orthovisc /Euflexxa, bracing, suggested exercises, supplements, and diet. Information from the data collection will be used to compare outcomes of non-surgical alternatives with the end point being knee arthroplasty. The information results will enhance our knowledge of the long-term efficacy and effectiveness of non-surgical interventions intended to treat the progression of osteoarthritis.
Hypotheses:
- Different non-surgical interventions such as PRP, Synvisc®, Orthrovisc®, Euflexxa, bracing, physical therapy, and a prescribed combination of exercise, diet, and supplements will demonstrate statistically significant differences in patient pain and functional outcomes compared to usual interventions including use of NSAIDs, corticosteroid injections, and use of assistive devices such as canes.
- Non-operative interventions for knee osteoarthritis will be associated with different rates of breakdown of articular cartilage and different rates of progression of osteoarthritis as evidenced by MRI or joint space narrowing on standing knee films?
- Education about available non-operative treatment methods may change time the end point of total or partial knee replacement for patients with knee osteoarthritis of varying severity.
- Different non-operative interventions will be associated with different times to total or partial knee arthroplasty in patient with knee osteoarthritis of similar severity.
- An electronic data capture system (EDC) for osteoarthritis patients will improve patient care and patient outcomes.
Visão geral do estudo
Status
Rescindido
Condições
Descrição detalhada
Specific Aims:
- To ascertain the long term success of non-surgical interventions intended to alleviate symptoms or slow progression of osteoarthritis of the knee.
- To ascertain if non-operative interventions for knee osteoarthritis improve patient pain, function, and quality of life.
- To ascertain if non-operative interventions for knee osteoarthritis affect the breakdown of articular cartilage and slow progression of osteoarthritis as evidenced by MRI or joint space narrowing on standing knee films?
- To ascertain the amount of time between the initial entry into care at HSS and the end point of total or partial knee replacement for patients with knee osteoarthritis of varying severity.
- To ascertain if non-operative interventions for knee osteoarthritis prolong time to knee replacement surgery.
- To implement at electronic data capture system (EDC) for osteoarthritis patients which will store validated patient reported outcomes, physical findings, and imaging results.
Tipo de estudo
Observacional
Inscrição (Real)
906
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10021
- Hospital for Special Surgery
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
30 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Hospital for Special Surgery knee osteoarthritis patients
Descrição
Inclusion Criteria:
- Age greater than 30 years and less than 80 years
- Knee pain for at least 6 weeks
- Pain rate greater than or equal to 4/10 on a visual analog scale
- Morning stiffness less than 30 minutes
- Crepitus on active motion of the knee, bony tenderness, or bony enlargement of the knee
- Willing and able to consider all medical treatment options used to manage osteoarthritis of the knee
- No contraindications to knee radiographs or MRI
- Willing to participate in a registry
- Able to understand and sign a consent
- Able to answer registry questions independently
Exclusion Criteria:
- Diagnosis of a systemic rheumatic disease or crystalline arthritis (ie RA, SLE, systemic sclerosis, psoriatic arthritis or psoriasis, gout, pseudogout, lyme arthritis, reactive arthritis, viral arthritis
- pregnant or nursing
- unable to give informed consent
- contraindication to MRI such as indwelling paemaker or cochlear implant
- requirement of metal equipment (such as oxygen)
- known claustrophobia
- gadolinium allergy
- lack of fluency in English. Unfortunately, we do not have the financial resources to offer full translation services
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Short Form (12) Health Survey (SF-12)
Prazo: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
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Change is being assessed.
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6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Knee injury and Osteoarthritis Outcome Score (KOOS)
Prazo: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
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Change is being assessed.
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6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Whole-Organ MRI Scoring (WORMS)
Prazo: baseline, 1 year, 2 years, 5 years
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Changes in MRI will be measured by a chance in the Whole-Organ MRI Scoring (WORMS) score of femur and tibia, and Outerbridge score for cartilage.
The Boston Osteoarthritis Knee Study defined cartilage loss using the WORMS score as "an increase in the score at any sub-region compared to baseline in any of the 14 subregions of the knee scored for cartilage in each knee."
For patients who have only standing radiographs available a 0.7 mm loss of joint space will be considered a significant loss over 3 years.
Bruyere et al predicted that "the cut off for minimum JSN maximizing sensitivity and specificity for predicting future surgery was a change of 0.7 mm or more in minimum joint space width over a period of three years."
Note: change is being assessed.
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baseline, 1 year, 2 years, 5 years
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X-ray with Kellgren-Lawrence Grading
Prazo: baseline, 4 years
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Change is being assessed.
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baseline, 4 years
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, Heyse SP, Hirsch R, Hochberg MC, Hunder GG, Liang MH, Pillemer SR, Steen VD, Wolfe F. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998 May;41(5):778-99. doi: 10.1002/1529-0131(199805)41:53.0.CO;2-V.
- Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17.
- Kon E, Mandelbaum B, Buda R, Filardo G, Delcogliano M, Timoncini A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma intra-articular injection versus hyaluronic acid viscosupplementation as treatments for cartilage pathology: from early degeneration to osteoarthritis. Arthroscopy. 2011 Nov;27(11):1490-501. doi: 10.1016/j.arthro.2011.05.011. Epub 2011 Aug 10.
- Peterfy CG, Guermazi A, Zaim S, Tirman PF, Miaux Y, White D, Kothari M, Lu Y, Fye K, Zhao S, Genant HK. Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritis. Osteoarthritis Cartilage. 2004 Mar;12(3):177-90. doi: 10.1016/j.joca.2003.11.003.
- Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72.
- Rhon D. Re: Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008;16:137-62. Osteoarthritis Cartilage. 2008 Dec;16(12):1585; author reply 1589. doi: 10.1016/j.joca.2008.04.019. Epub 2008 Jun 2. No abstract available.
- Cameron ML, Briggs KK, Steadman JR. Reproducibility and reliability of the outerbridge classification for grading chondral lesions of the knee arthroscopically. Am J Sports Med. 2003 Jan-Feb;31(1):83-6. doi: 10.1177/03635465030310012601.
- Hunter DJ, Li J, LaValley M, Bauer DC, Nevitt M, DeGroot J, Poole R, Eyre D, Guermazi A, Gale D, Felson DT. Cartilage markers and their association with cartilage loss on magnetic resonance imaging in knee osteoarthritis: the Boston Osteoarthritis Knee Study. Arthritis Res Ther. 2007;9(5):R108. doi: 10.1186/ar2314.
- Ornetti P, Brandt K, Hellio-Le Graverand MP, Hochberg M, Hunter DJ, Kloppenburg M, Lane N, Maillefert JF, Mazzuca SA, Spector T, Utard-Wlerick G, Vignon E, Dougados M. OARSI-OMERACT definition of relevant radiological progression in hip/knee osteoarthritis. Osteoarthritis Cartilage. 2009 Jul;17(7):856-63. doi: 10.1016/j.joca.2009.01.007. Epub 2009 Feb 9.
- Loza E, Benito-Ruiz P, Blanco F, de Miguel E, Roman JA; ARTROACAS study group, Spain. Feasibility and efficacy of a multidisciplinary health care programme for patients with knee osteoarthritis. Clin Exp Rheumatol. 2011 Nov-Dec;29(6):913-20. Epub 2011 Dec 22.
- Keller SD, Bayliss MS, Ware JE Jr, Hsu MA, Damiano AM, Goss TF. Comparison of responses to SF-36 Health Survey questions with one-week and four-week recall periods. Health Serv Res. 1997 Aug;32(3):367-84.
- Pincus T, Maclean R, Yazici Y, Harrington JT. Quantitative measurement of patient status in the regular care of patients with rheumatic diseases over 25 years as a continuous quality improvement activity, rather than traditional research. Clin Exp Rheumatol. 2007 Nov-Dec;25(6 Suppl 47):69-81.
- Gourlay ML, Fine JP, Preisser JS, May RC, Li C, Lui LY, Ransohoff DF, Cauley JA, Ensrud KE; Study of Osteoporotic Fractures Research Group. Bone-density testing interval and transition to osteoporosis in older women. N Engl J Med. 2012 Jan 19;366(3):225-33. doi: 10.1056/NEJMoa1107142.
- Roos EM, Roos HP, Lohmander LS. WOMAC Osteoarthritis Index--additional dimensions for use in subjects with post-traumatic osteoarthritis of the knee. Western Ontario and MacMaster Universities. Osteoarthritis Cartilage. 1999 Mar;7(2):216-21. doi: 10.1053/joca.1998.0153.
- Poissant L, Pereira J, Tamblyn R, Kawasumi Y. The impact of electronic health records on time efficiency of physicians and nurses: a systematic review. J Am Med Inform Assoc. 2005 Sep-Oct;12(5):505-16. doi: 10.1197/jamia.M1700. Epub 2005 May 19.
- Wilson AS, Kitas GD, Carruthers DM, Reay C, Skan J, Harris S, Treharne GJ, Young SP, Bacon PA. Computerized information-gathering in specialist rheumatology clinics: an initial evaluation of an electronic version of the Short Form 36. Rheumatology (Oxford). 2002 Mar;41(3):268-73. doi: 10.1093/rheumatology/41.3.268.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de julho de 2013
Conclusão Primária (Real)
21 de março de 2014
Conclusão do estudo (Real)
21 de março de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
16 de julho de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de julho de 2013
Primeira postagem (Estimativa)
23 de julho de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de dezembro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de novembro de 2017
Última verificação
1 de novembro de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 29031
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .