Pilot Trial to Assess the Feasibility of Implementing Objective Parameters in Patients Affected by Knee Osteoarthritis

NCT03421054 | Completed DMC

• 1 other identifier: Pilot OPRPH/0117/FS
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot, open non-controlled trial to assess the feasibility of implementing objective parameters as primary endpoints in a clinical trial with patients affected by knee osteoarthritis.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• synovial effusion reduction

  Correlation between reduction in VAS (at rest) and ultrasonography parameters

  week 4 and 8

Secondary Outcomes (1)

• pain reduction

  week 4 and 8

Study Arms (1)

nutraceutical containing HA

OTHER

pain reduction of the affected knee in the patients assuming nutraceutical containing HA

Dietary Supplement: patients assuming nutraceutical containing HA

Interventions

patients assuming nutraceutical containing HA DIETARY_SUPPLEMENT

pain reduction of the affected knee in the patients assuming nutraceutical containing HA

nutraceutical containing HA

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender and age from 50 to 70 years
• Symptomatic osteoarthritis (OA) of the knee with mild joint discomfort for at least 6 months prior to enrollment, following ACR criteria with history and physical examination (1). Subjects diagnosed with bilateral knee OA will be asked to specify the most affected knee at baseline, and this knee will be evaluated throughout the study period.
• Available confirmatory X-ray (performed within the previous 6 months) diagnosis (Kellgren/Lawrence score 2) at the evaluated knee joint (2).
• Subjects experienced pain for at least 15 of the 30 days prior to the start of the study.

You may not qualify if:

• Subjects who have any inflammatory arthritic condition (different from the OA of the knee), fibromyalgia, multiple sclerosis or autoimmune disorder.
• Treatment with oral corticosteroids within 4 weeks before screening.
• Intra-articular injections of HA or corticosteroids in the target joint within 3 months before screening.
• Treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, methylsulfonylmethane, HA, diacerein) 2 weeks before the selection.
• HA-containing nutritional supplements or cosmetics during the month before the study.
• Previous surgical treatment of knee joint(s) or its necessity; complication(s) necessary for hospitalization and surgical treatment.
• Significant injury to the target joint within the past 6 months prior to screening (identified from medical history).
• Subjects following an energy-restricted diet for weight loss.
• Pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception.
• Subjects with cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
• Participation in an interventional clinical study in the previous 30 days.

Sponsors & Collaborators

• River Pharma S.r.l.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

Opera Contract Research Organization S.r.l.

Timișoara, Timiș County, 300209, Romania

Location

Related Publications (37)

• Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561.

  PMID: 23559821 BACKGROUND

• Carvalho NA, Bittar ST, Pinto FR, Ferreira M, Sitta RR. Manual for guided home exercises for osteoarthritis of the knee. Clinics (Sao Paulo). 2010 Jun;65(8):775-80. doi: 10.1590/s1807-59322010000800006.

  PMID: 20835554 BACKGROUND

• Voelker R. Few adults with knee osteoarthritis meet national guidelines for physical activity. JAMA. 2011 Oct 5;306(13):1428, 1430. doi: 10.1001/jama.2011.1388. No abstract available.

  PMID: 21972300 BACKGROUND

• Pai YC, Chang HJ, Chang RW, Sinacore JM, Lewis JL. Alteration in multijoint dynamics in patients with bilateral knee osteoarthritis. Arthritis Rheum. 1994 Sep;37(9):1297-304. doi: 10.1002/art.1780370905.

  PMID: 7945492 BACKGROUND

• Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gosselin R, Grainger R, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Ma J, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2163-96. doi: 10.1016/S0140-6736(12)61729-2.

  PMID: 23245607 BACKGROUND

• Cutolo M, Berenbaum F, Hochberg M, Punzi L, Reginster JY. Commentary on recent therapeutic guidelines for osteoarthritis. Semin Arthritis Rheum. 2015 Jun;44(6):611-7. doi: 10.1016/j.semarthrit.2014.12.003. Epub 2014 Dec 24.

  PMID: 25677861 BACKGROUND

• Bruyere O, Cooper C, Pelletier JP, Branco J, Luisa Brandi M, Guillemin F, Hochberg MC, Kanis JA, Kvien TK, Martel-Pelletier J, Rizzoli R, Silverman S, Reginster JY. An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally: a report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). Semin Arthritis Rheum. 2014 Dec;44(3):253-63. doi: 10.1016/j.semarthrit.2014.05.014. Epub 2014 May 14.

  PMID: 24953861 BACKGROUND

• Bruyere O, Burlet N, Delmas PD, Rizzoli R, Cooper C, Reginster JY. Evaluation of symptomatic slow-acting drugs in osteoarthritis using the GRADE system. BMC Musculoskelet Disord. 2008 Dec 16;9:165. doi: 10.1186/1471-2474-9-165.

  PMID: 19087296 BACKGROUND

• Bannuru RR, Schmid CH, Kent DM, Vaysbrot EE, Wong JB, McAlindon TE. Comparative effectiveness of pharmacologic interventions for knee osteoarthritis: a systematic review and network meta-analysis. Ann Intern Med. 2015 Jan 6;162(1):46-54. doi: 10.7326/M14-1231.

  PMID: 25560713 BACKGROUND

• Navarro-Sarabia F, Coronel P, Collantes E, Navarro FJ, de la Serna AR, Naranjo A, Gimeno M, Herrero-Beaumont G; AMELIA study group. A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated intra-articular injections of hyaluronic acid in knee osteoarthritis: the AMELIA project. Ann Rheum Dis. 2011 Nov;70(11):1957-62. doi: 10.1136/ard.2011.152017. Epub 2011 Aug 17.

  PMID: 21852252 BACKGROUND

• Waddell DD, Bricker DC. Total knee replacement delayed with Hylan G-F 20 use in patients with grade IV osteoarthritis. J Manag Care Pharm. 2007 Mar;13(2):113-121. doi: 10.18553/jmcp.2007.13.2.113.

  PMID: 17330972 BACKGROUND

• Reed RK, Townsley MI, Laurent TC, Taylor AE. Hyaluronan flux from cat intestine: changes with lymph flow. Am J Physiol. 1992 Feb;262(2 Pt 2):H457-62. doi: 10.1152/ajpheart.1992.262.2.H457.

  PMID: 1539704 BACKGROUND

• Balogh L, Polyak A, Mathe D, Kiraly R, Thuroczy J, Terez M, Janoki G, Ting Y, Bucci LR, Schauss AG. Absorption, uptake and tissue affinity of high-molecular-weight hyaluronan after oral administration in rats and dogs. J Agric Food Chem. 2008 Nov 26;56(22):10582-93. doi: 10.1021/jf8017029.

  PMID: 18959406 BACKGROUND

• Hisada N, Satsu H, Mori A, Totsuka M, Kamei J, Nozawa T, Shimizu M. Low-molecular-weight hyaluronan permeates through human intestinal Caco-2 cell monolayers via the paracellular pathway. Biosci Biotechnol Biochem. 2008 Apr;72(4):1111-4. doi: 10.1271/bbb.70748. Epub 2008 Apr 7.

  PMID: 18391466 BACKGROUND

• Laznicek M, Laznickova A, Cozikova D, Velebny V. Preclinical pharmacokinetics of radiolabelled hyaluronan. Pharmacol Rep. 2012;64(2):428-37. doi: 10.1016/s1734-1140(12)70784-3.

  PMID: 22661195 BACKGROUND

• Altman RD, Manjoo A, Fierlinger A, Niazi F, Nicholls M. The mechanism of action for hyaluronic acid treatment in the osteoarthritic knee: a systematic review. BMC Musculoskelet Disord. 2015 Oct 26;16:321. doi: 10.1186/s12891-015-0775-z.

  PMID: 26503103 BACKGROUND

• du Souich P. Absorption, distribution and mechanism of action of SYSADOAS. Pharmacol Ther. 2014 Jun;142(3):362-74. doi: 10.1016/j.pharmthera.2014.01.002. Epub 2014 Jan 21.

  PMID: 24457028 BACKGROUND

• Oe M, Tashiro T, Yoshida H, Nishiyama H, Masuda Y, Maruyama K, Koikeda T, Maruya R, Fukui N. Oral hyaluronan relieves knee pain: a review. Nutr J. 2016 Jan 27;15:11. doi: 10.1186/s12937-016-0128-2.

  PMID: 26818459 BACKGROUND

• Yasui T, Akatsuka M, Tobetto K, Hayaishi M, Ando T. The effect of hyaluronan on interleukin-1 alpha-induced prostaglandin E2 production in human osteoarthritic synovial cells. Agents Actions. 1992 Sep;37(1-2):155-6. doi: 10.1007/BF01987905.

  PMID: 1456177 BACKGROUND

• Homandberg GA, Ummadi V, Kang H. The role of insulin-like growth factor-I in hyaluronan mediated repair of cultured cartilage explants. Inflamm Res. 2004 Aug;53(8):396-404. doi: 10.1007/s00011-004-1276-y. Epub 2004 Aug 10.

  PMID: 15316671 BACKGROUND

• Wang CT, Lin YT, Chiang BL, Lin YH, Hou SM. High molecular weight hyaluronic acid down-regulates the gene expression of osteoarthritis-associated cytokines and enzymes in fibroblast-like synoviocytes from patients with early osteoarthritis. Osteoarthritis Cartilage. 2006 Dec;14(12):1237-47. doi: 10.1016/j.joca.2006.05.009. Epub 2006 Jun 30.

  PMID: 16806998 BACKGROUND

• Waller KA, Zhang LX, Fleming BC, Jay GD. Preventing friction-induced chondrocyte apoptosis: comparison of human synovial fluid and hylan G-F 20. J Rheumatol. 2012 Jul;39(7):1473-80. doi: 10.3899/jrheum.111427. Epub 2012 Jun 1.

  PMID: 22660808 BACKGROUND

• Bernad Pineda M. Current status of symptomatic slow-acting drugs for osteoarthritis (SYSADOAs) in Spain. Reumatol Clin. 2016 Jul-Aug;12(4):181-3. doi: 10.1016/j.reuma.2016.03.012. Epub 2016 Apr 18. No abstract available. English, Spanish.

  PMID: 27101743 BACKGROUND

• Tashiro T, Seino S, Sato T, Matsuoka R, Masuda Y, Fukui N. Oral administration of polymer hyaluronic acid alleviates symptoms of knee osteoarthritis: a double-blind, placebo-controlled study over a 12-month period. ScientificWorldJournal. 2012;2012:167928. doi: 10.1100/2012/167928. Epub 2012 Nov 20.

  PMID: 23226979 BACKGROUND

• Nagaoka I, Nabeshima K, Murakami S, Yamamoto T, Watanabe K, Tomonaga A, Yamaguchi H. Evaluation of the effects of a supplementary diet containing chicken comb extract on symptoms and cartilage metabolism in patients with knee osteoarthritis. Exp Ther Med. 2010 Sep;1(5):817-827. doi: 10.3892/etm.2010.114. Epub 2010 Jul 12.

  PMID: 22993606 BACKGROUND

• D'Agostino MA, Conaghan P, Le Bars M, Baron G, Grassi W, Martin-Mola E, Wakefield R, Brasseur JL, So A, Backhaus M, Malaise M, Burmester G, Schmidely N, Ravaud P, Dougados M, Emery P. EULAR report on the use of ultrasonography in painful knee osteoarthritis. Part 1: prevalence of inflammation in osteoarthritis. Ann Rheum Dis. 2005 Dec;64(12):1703-9. doi: 10.1136/ard.2005.037994. Epub 2005 May 5.

  PMID: 15878903 BACKGROUND

• Hartung W, Kellner H, Strunk J, Sattler H, Schmidt WA, Ehrenstein B, Fleck M, Backhaus M. Development and evaluation of a novel ultrasound score for large joints in rheumatoid arthritis: one year of experience in daily clinical practice. Arthritis Care Res (Hoboken). 2012 May;64(5):675-82. doi: 10.1002/acr.21574.

  PMID: 22183834 BACKGROUND

• Serban O, Porojan M, Deac M, Cozma F, Solomon C, Lenghel M, Micu M, Fodor D. Pain in bilateral knee osteoarthritis - correlations between clinical examination, radiological, and ultrasonographical findings. Med Ultrason. 2016 Sep;18(3):318-25. doi: 10.11152/mu.2013.2066.183.pin.

  PMID: 27622408 BACKGROUND

• Wu PT, Shao CJ, Wu KC, Wu TT, Chern TC, Kuo LC, Jou IM. Pain in patients with equal radiographic grades of osteoarthritis in both knees: the value of gray scale ultrasound. Osteoarthritis Cartilage. 2012 Dec;20(12):1507-13. doi: 10.1016/j.joca.2012.08.021. Epub 2012 Sep 1.

  PMID: 22944523 BACKGROUND

• Yoshimura M, Aoba Y, Watari T, Momomura R, Watanabe K, Tomonaga A, Matsunaga M, Suda Y, Lee WY, Asai K, Yoshimura K, Nakagawa T, Yamamoto T, Yamaguchi H, Nagaoka I. Evaluation of the effect of a chicken comb extract-containing supplement on cartilage and bone metabolism in athletes. Exp Ther Med. 2012 Oct;4(4):577-580. doi: 10.3892/etm.2012.646. Epub 2012 Jul 24.

  PMID: 23170108 BACKGROUND

• Yang CC, Hsu YL. A review of accelerometry-based wearable motion detectors for physical activity monitoring. Sensors (Basel). 2010;10(8):7772-88. doi: 10.3390/s100807772. Epub 2010 Aug 20.

  PMID: 22163626 BACKGROUND

• Steins D, Dawes H, Esser P, Collett J. Wearable accelerometry-based technology capable of assessing functional activities in neurological populations in community settings: a systematic review. J Neuroeng Rehabil. 2014 Mar 13;11:36. doi: 10.1186/1743-0003-11-36.

  PMID: 24625308 BACKGROUND

• Trudeau J, Van Inwegen R, Eaton T, Bhat G, Paillard F, Ng D, Tan K, Katz NP. Assessment of pain and activity using an electronic pain diary and actigraphy device in a randomized, placebo-controlled crossover trial of celecoxib in osteoarthritis of the knee. Pain Pract. 2015 Mar;15(3):247-55. doi: 10.1111/papr.12167. Epub 2014 Feb 5.

  PMID: 24494935 BACKGROUND

• Wylde V, Lenguerrand E, Brunton L, Dieppe P, Gooberman-Hill R, Mann C, Blom AW. Does measuring the range of motion of the hip and knee add to the assessment of disability in people undergoing joint replacement? Orthop Traumatol Surg Res. 2014 Apr;100(2):183-6. doi: 10.1016/j.otsr.2013.09.016. Epub 2014 Feb 17.

  PMID: 24556210 BACKGROUND

• Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

  PMID: 20053272 BACKGROUND

• Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.

  PMID: 15189396 BACKGROUND

• Dogaru DE, Rosu S, Barattini DF, Guadagna S, Barattini L, Andor B. Assessment of the Feasibility of Objective Parameters as Primary End Points for Patients Affected by Knee Osteoarthritis: Protocol for a Pilot, Open Noncontrolled Trial (:SMILE:). JMIR Res Protoc. 2024 Jun 28;13:e13642. doi: 10.2196/13642.

  PMID: 38941599 DERIVED

Related Links

• 46\. Proverb resources: Ashanti Proverbs from Ghana

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Bogdan Andor, MD

  MEDICALI'S

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: March 19, 2018
• Primary Completion: April 15, 2018
• Study Completion: May 14, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

RO (1)